French Industry Loses Appeal Against Standardized OTC Packaging And

No. 42 • 4 November 2019

by “facilitating identification….and improving the visibility, readability and understanding of labeling.” The regulator is also looking to curb the practice of umbrella branding for non-prescription drugs which it claims is a source of confusion and misuse among consumers. Its recommendations advise MAHs when seeking product approval not to use a brand name which contains all or part of the name of another existing OTC line or a product which was previously available on the market. In response to ANSM, Afipa described the proposals as “counterproductive and dangerous for patients” and appealed to the court on the grounds that the regulator was abusing its power. Rejecting a request by ANSM to have the case thrown out, the court said Afipa French Industry Loses Appeal had grounds for its appeal. Against Standardized OTC INDUSTRY TO BE ‘SIGNIFICANTLY’ IMPACTED While ANSM’s proposals were technically Packaging And Curb On Branding recommendations and devoid of legal ef- TOM GALLEN [email protected] fects, they had the “purpose of significantly influencing the behavior of marketing TC drug packaging could before that the outer packaging of non-prescrip- authorization holders, as well as the be- long become uniform and be- tion drugs sold in solid oral form should havior of patients using self-medication,” Oreft of branding in France after display its active ingredient(s) in a font the court judged. As such, the proposals the country’s highest court rejected the larger than that used for all other informa- were “therefore likely to produce signifi- protestations of national self-medication tion, including the brand name or manu- cant effects,” particularly for the OTC in- industry group Afipa. facturer’s name. Marketing authorization dustry, it said. France’s Conseil d’Etat ruled against holders are also advised that brand names On the question of the packaging rec- Afipa, which had sought to have annulled should be displayed in a standardized font ommendations, Afipa argued that ANSM recommendations adopted last year by and all logos, for either the brand or com- was seeking to amend the public health national drug regulator ANSM to stan- pany, should be confined to the reverse or code in such a way that would treat OTC dardize OTC drug packaging and curb side panels of the package. drugs differently from their prescription the practice of umbrella branding. As a counterparts. result, the recommendations continue to MOTIVATED BY PATIENT SAFETY In response, the court said ANSM’s stand. ANSM has stated its goal is to en- ANSM’s rationale for removing branding recommendations did not disregard sure that the recommendations are “prop- and standardizing packaging is to reduce the meaning and scope of Article R. erly implemented by manufacturers.” the risk of medication error and promote 5121-138 of the code which stipulates ANSM’s recommendations stipulate the proper use of non-prescription drugs CONTINUED ON PAGE 4

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CONTINUED FROM PAGE 1 association maintained, which would shared the same or closely related names the information drug packaging must breach Article L. 714-5 of the intellec- were even more likely to be confused by legally display. The regulator was not tual property code. patients than prescription drugs given seeking to amend the code to add to Dismissing this argument, the court they could be obtained without the over- the list of particulars which must ap- said that while ANSM’s recommenda- sight of a doctor. pear, the court judged, but to make tions advocated that logos and brand- By causing confusion, umbrella brand- recommendations relating to the lay- ing should be kept off the front of the ing could also mislead patients regarding out and presentation of those particu- packaging – in favor of the active ingre- a drug’s quality or properties, the court lars, in order to improve readability and dient and strength – they did not pre- noted, which was prohibited under Article consumer understanding. clude their inclusion on other areas of R. 5121-3 of the health code. While ANSM had proposed general the pack and labeling. In recommending MAHs should avoid principles” of “comprehensibility, visibility Addressing Afipa’s concerns about umbrella branding, ANSM was motivated and legibility of statements” – with an em- how ANSM’s packaging proposals by “the risks of medication errors this prac- phasis on the prominent display of the ac- would impact patients, the court said tice was likely to entail”, the court said, and tive ingredient and its strength – the regu- that if packaging was standardized and had therefore not committed any “mani- lator was allowing MAHs to adapt these logos and branding removed patients fest error of judgement.” recommendations according to their own would still be able to identify the drugs Summing up its ruling, the court said constraints, the court observed. they needed by active ingredient. The Afipa was not justified in maintaining that Afipa also claimed that ANSM’s pro- measure would not increase the likeli- ANSM’s recommendations were based on posal to remove branding and logos hood of confusion between medicinal “materially incorrect facts,” or by claiming from the front of drug packs infringed products, it judged. the regulator had overstepped the mark, Article R. 5121-139 of the code, which as the motivation of the move was “to im- states MAHs are permitted to include UMBRELLA BRANDING prove the readability of the information “the distinctive sign/mark of the com- ‘CONFUSING’ carried on packaging and reduce the risk pany.” Companies also risked losing Turning to the issue of umbrella brand- of drug errors.” their rights to certain trademarks if ing, the court found that contrary to Afi- brand names could not be included, the pa’s claims, non-prescription drugs which Published online 28 October 2019 Reckitt’s New CEO Wants Immediate Changes As OTC Sales Slump In Q3

TOM GALLEN [email protected]

oo many changes too quickly” RB’s Sales in Q3 By Business is the route cause of the perfor- BUSINESS SALES (£M) LIKE-FOR-LIKE CHANGE (%) REPORTED CHANGE (%) “Tmance issues afflicting Reckitt Benckiser Group PLC’s Health business, IFCN 737 +7.2 +11.8 believes new CEO Laxman Narasimhan. OTC 496 -6.8 -3.7 Addressing investors as RB reported Other Health 726 -2.5 +1.3 third-quarter sales at the Health unit down by 0.3% to £1.96bn ($2.53bn), Total Health 1,959 -0.3 +3.6 Narasimhan – who took the reins from Total Hygiene Home 1,326 +4.5 +7.9 Rakesh Kapoor on 1 September – Total RB 3,285 +1.6 +5.3% claimed the latest results were the price IFCN = Infant and Child Nutrition (Source - RB) to pay for a poorly executed strategic shift at the business. (Also see “Reckitt Names New CEO To Ignite Growth And sion to shake-up the company’s op- ing all its attention on the Mead Johnson Lead Digital Transformation” - HBW In- erating structure with the creation of integration and the organisational shake- sight, 13 Jun, 2019.) two independent business units, one up, RB had “taken our eye off the ball on Acquiring Mead Johnson in 2017 serving the health market and the oth- execution,” he said. and moving into the infant nutrition er hygiene and home. These execution missteps had contin- market for the first time had caused “Things have gone wrong over the last ued to blight Health in the third quar- “significant disruption” at Health, ob- three years,” Narasimhan admitted. “We ter, Narasimhan noted, particularly at its served Narasimhan, as had the deci- ran the engine too hot in places.” By focus- OTC business.

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US CONSUMER HEALTH WOES RB’sR HealthB's He Salesalth In S Q3ale Bys RegionIn Q3 By Region OTC like-for-like sales – which exclude the 1000 6 impact of currency fluctuations, acquisi- 900 4 tions and disposals – had fallen by 6.8% to £496m in the three months, RB reported, 800 2 reflecting greater caution from US retailers 700 0 on inventory levels for cold and flu prod- 600 -2 ucts as a result of a weak season last year. 500 -4 This had hit sales of “powerbrand” Mu- e change (%) 400 -6 cinex, as well as some smaller lines such as Q3 Sales (£m) e-for-lik 300 -8 Delysm, the firm noted. Lik While variability in retailer buying pat- 200 -10 terns was understandable, RB had failed to 100 -12 sufficiently anticipate it, admitted CFO Adri- 0 -14 an Hennah, highlighting the executional is- North America Europe/ANZ Developing Markets sues that were dogging the company. Q3 Sales (£m) Like-for-like change (%) “It is abundantly clear we were not close enough to all of those retailers to get a good reading of what was going happen,” On a more positive note, efforts to refo- reflected the weak performance in the said Hennah. cus the Scholl brand following an ill-fated prior-year period. Adjusted for the impact “What is, of course, remarkable or note- move into the foot-care devices market of the supply disruption, RB said sales in worthy, is that managing inventory levels had begun to bear fruit, the firm said, the reporting region had declined by 3%, is a key part for all consumer goods and with the line cited as a key driver in an im- reflecting the issues facing IFCN and the one we spend a great deal of effort on proved performance for the Health unit in Durex and Dettol brands in China. around the world, particularly in distribu- Europe in the third quarter. Europe/ANZ saw an “encouraging return tors and traditional trade.” to growth” the quarter, RB reported, with Noting that the inventory issue had INFANT NUTRITION REMAINS A sales up by 3.5% to £514m, thanks to broad- “come as a surprise” to RB’s senior lead- HEADACHE based growth across countries and brands. ership team, Hennah implied something While both Other Health and OTC record- Away from the Health business, RB’s Hy- had gone wrong on the ground in the US. ed sales declines in the three months, the giene Home unit posted sales up by 4.5% to “One of the particularly remarkable as- Infant and Child Nutrition (IFCN) business £1.33bn. This improvement was enough to pects of the destocking we’ve seen here is posted turnover up by to 7.2% to £737m. offset the poor showing from Health leav- [that] it wasn’t in channels which are lightly However, Hennah admitted that this ing total group sales up by 1.6% to £3.29bn. managed distributor channels. It was in growth rate was misleading as sales in the the biggest and arguably, among the most prior-year period had been down signifi- CEO INSTITUTES IMMEDIATE sophisticated customers we have in the cantly due to supply disruption to the Chi- CHANGES world,” he pointed out. “So, it was a very dif- nese market. Adjusted to account for this, Characterizing RB’s third-quarter perfor- ferent phenomenon from that where you IFCN’s sales in the third quarter actually mance overall as “disappointing”, Nara- normally see inventory fluctuations.” declined by 3%. simhan said work to address the issues Excluding its inventory troubles, the Following that supply outage, it was affecting the company, particularly in the OTC business was performing steadily taking RB longer than expected to recover Health division, was already underway. and not losing market share, Hennah said. consumers in China, the firm said, in what “I am prioritizing execution and opera- Nurofen, Gaviscon and Strepsils were de- was an increasingly competitive market tional performance as a matter of urgency. livering market share growth while the given falling birth rates. “We are making I have made it clear within the organisa- company had also seen an improved per- progress,” insisted Hennah, “but it is hard tion that any activities that detract focus formance from its local OTC brands. fought and will continue to be tough.” and attention from improving our opera- Turning to its Other Health business, RB Conversely, the outlook for the North tional performance, be paused.” reported sales down by 2.5% to £726m, American market was much rosier, he said, Given the issues identified and the per- as again US retailer destocking of certain with RB continuing to drive strong share formance year-to-date, RB has revised its vitamin, mineral and supplement (VMS) improvement, underpinned by innova- group net revenue target down for the brands hampered growth. tion and success in new channels. second time in 2019 to from 2-3% to 0-2%. The weaker VMS performance had been Gains in the US infant nutrition market Adjusted operating margins are now ex- compounded by struggles for its Durex failed to offset RB’s OTC travails, with total pected to see a modest decline. sexual health brand and Dettol hygiene Health sales in North America slumping “I firmly believe that we have significant line, RB noted, with the former continu- by 12.3% to £464m in the three months. potential, with an outstanding set of brands ing to suffer from competitive pressures While turnover in Developing Markets in structural growth categories,” Narasim- in China. advanced by 4.1% to £981m, this gain han insisted. Published online 24 Oct 2019

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FDA Adds Homeopathic Enforcement Details, Subtracts Compliance Policy Guide MALCOLM SPICER [email protected]

he US homeopathic drug industry MOST PRODUCTS ‘OUTSIDE acknowledging that much of the homeo- leaves too much to risk, says the CATEGORIES’ FOR PRIORITY pathic market isn’t a concern. T Food and Drug Administration in ENFORCEMENT “Consumers have shown that they cancelling a policy guide that linked com- The CPG essentially ceded FDA’s oversight value the relief and benefits provided by pliance to industry standards rather than of homeopathics to manufacturers’ com- these medicines. FDA has conceded that FDA approval and imposing a risk-based pliance with HPUS standards. That ap- the new draft guidance will have little enforcement approach. proach, though, leaves too much room for impact on most marketed products,” said The agency on 24 October published error, the FDA found. AAHP counsel Alvin Lorman, an attorney a revised draft guidance for its oversight In the CPG withdrawal notice, it says in Washington. of the homeopathic industry, detailing it has “documented many serious viola- The trade group will file detailed com- its enforcement approach by identifying tions of current good manufacturing ments on the revised draft guidance, types of products that pose “higher risks practice (CGMP) requirements by manu- which it says “is not much different from to public health.” facturers of homeopathic drug products, how the agency has exercised its enforce- Additionally, along with the draft raising significant concerns about the ment discretion in the past.” guidance the FDA published a Federal Register notice stating that is withdrawing Compliance Policy Guide 400.400, We have additional coverage of this regulatory which it published in 1988 to allow homeopathic drugs to be available in the change by the FDA on the HBW Insight website, US even though they are not subject https://bit.ly/2q7rGKd to pre-market approval or other review process that the agency imposes on all other categories of drugs. In addition to products found to contain unsafe ingredients or manufactured in safety of the products made with inad- MARKET AND conditions noncompliant with FDA regula- equate process controls.” ‘POPULATION EXPOSURE’ tions, the agency says in the draft guidance The revised draft guidance, the agency GROWTH CONCERN FDA that it will prioritize enforcement against states, is “intended to provide notice that The revised draft guidance and the CPG homeopathics with routes of administra- any homeopathic drug product that is withdrawal are the latest steps in the FDA’s tion other than oral and topical, such as na- being marketed illegally is subject to consideration launched in 2015 at chang- sal gels or intravenous formulations. FDA enforcement action at any time.” It ing its regulatory approach for the ho- The FDA is not ordering an end to sales also adds, though, that it “anticipates that meopathic market, “in light of the growth and production of OTC or Rx homeopath- many homeopathic drug products will of the industry and passage of time since ics. It notes in the CPG withdrawal no- fall outside the categories of drug prod- the issuance” of the CPG, according to the tice that the definition of a drug under ucts that FDA intends to prioritize for en- notice on withdrawing the policy guide. agency regulations includes “articles rec- forcement and regulatory.” The FDA references the 2007-2012 Na- ognized in … the official Homoeopathic The guidance, for the first time, states tional Health Interview Survey conducted Pharmacopoeia of the United States.” a definition the FDA will apply in regu- by the Centers for Disease Control and lating homeopathics: “a drug product Prevention’s National Center for Health that is labeled as ‘homeopathic,’ and Statistics, showing around 15% of US is labeled as containing only active in- adults using homeopathic products. gredients and dilutions (e.g., 10X, 20X) “This growth, and the increased popu- listed for those active ingredients in lation exposure that it apparently repre- the Homeopathic Pharmacopeia of the sents, has contributed to FDA’s enhanced United States.” focus on the safety of homeopathic drugs The American Association of Homeo- in recent years,” the agency says in the CPG pathic Pharmacists says the agency’s draft withdrawal notice. FDA draft guidance: homeopathics once “were mostly prepared by homeopathic guidance and CPG withdrawal will disrupt Since beginning its evaluation, the FDA physicians for individual patients” but today the availability of a small part of homeo- conducted a public hearing homeopathic “are widely marketed as [OTC] products.” pathics and it points out that the FDA is safety and efficacy the same year and in

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2017 published its first draft guidance that identified problems it trixx Is Confident History Will Repeat Itself” - Pink Sheet, 29 Jun, will target for enforcement while allowing the products to remain 2009.) Used as labeled, the products delivered “significant dai- available without pre-market approval. (Also see “FDA ‘Evolving’ ly exposure to intranasal zinc, raising a serious safety concern,” Homeopathic Drug Enforcement With Risk-Based Approach” - HBW the draft guidance states. Insight, 19 Dec, 2017.) Of particular concern to the FDA, the draft guidance suggests, is The first draft stated that the CPG would be withdrawn when the absence in the marketplace of a distinction between homeo- the guidance was finalized, but that statement is absent from the pathics and nonprescription drugs available through new drug revised draft. “FDA believes that it is appropriate to withdraw CPG applications or under the agency’s OTC monograph. 400.400 at this time, rather than waiting for the issuance of the “In the past, these products were mostly prepared by homeo- final guidance,” it says in the CPG withdrawal notice. pathic physicians for individual patients. Today they are frequently In 2016, its evaluation identified 99 cases of adverse events mass manufactured and widely marketed as [OTC] products,” the consistent with belladonna toxicity, including reports of infant draft guidance states. deaths and seizures, possibly related to teething products. “In some instances, consumers may not even realize that the Further investigation determined that the poisonous bella- product they’re taking is homeopathic. Homeopathic drug prod- donna alkaloids in some of the products far exceeded the la- ucts are often placed on store shelves next to FDA-approved [OTC] beled amounts, raising a serious safety concern. (Also see “FTC drug products, or OTC drug products that comply with an OTC Homeopathic Disclaimer Policy Should Prompt FDA Changes – drug monograph issued by FDA, and packaging may not clearly Advocacy Group” - Pink Sheet, 21 Nov, 2016.) identify that a particular product is homeopathic,” said a represen- The revised draft guidance also references more than 130 tative for the FDA Center for Drug Evaluation and Research in a reports of anosmia, loss of the sense of smell, linked to use of statement to HBW Insight. Zicam homeopathic intranasal zinc products that the agency received in 2009. (Also see “Zicam Lawsuits Multiply, But Ma- Published online 24 October 2019 Australia Finds ‘Unacceptable’ Levels Of NDMA In 80% Of Ranitidine Batches

TOM GALLEN [email protected]

ustralia’s Therapeutic Goods Ad- Batches of ranitidine drugs marketed This method had a limit of quantitation ministration says the levels of by all 10 of the sponsors were found to of 0.1ppm NDMA, equivalent to 0.1 mi- Apotential carcinogen N-nitrosodi- contain levels of NDMA in breach of the crogram of NDMA per gram of ranitidine methylamine (NDMA) its testing has iden- 0.3ppm limit. active ingredient. tified in ranitidine heartburn remedies Just 26 batches had an acceptable Noting that the method did not give a are “unacceptable” leading the agency to level of NDMA, according to the TGA, all fully linear response above 3 ppm, TGA withdraw numerous products from sale. of which were marketed by either Arrow said NDMA values greater than this were Prompted by US Food and Drug Admin- Pharma Pty Ltd or Sandoz Pty Ltd. considered to be estimates only. istration and European Medicines Agency Of the 34 products tested, all but warnings about potential ranitidine con- one – RANITIDINE SANDOZ ranitidine PRODUCTS RECALLED, GREATER tamination in September, the TGA tested 50mg/5mL (as hydrochloride) concen- OVERSIGHT TO FOLLOW 135 batch samples of ranitidine drugs trated injection ampoules – had a level of As a result of these tests, TGA said it had (from 34 products) sold in Australia by 10 contamination above the limit in at least recalled all products with levels of NDMA different sponsors. The tested products in- one batch. at or above 0.3ppm while all batches cluded both OTC and prescription presen- with levels below 0.3 ppm are still avail- tations of ranitidine. USED FDA TESTING METHOD able for sale. The testing identified 109 batches, or Explaining its testing process, the regula- New requirements for ranitidine prod- 81% of the total, that contained levels of tor said its TGA Laboratories branch had ucts would soon be introduced, the agen- NDMA above the internationally agreed analysed a selection of the batch samples cy noted, to ensure that they did not con- limit of 0.3 parts per million (ppm). provided by sponsors in order to assess tain unacceptable levels of NDMA. The most contaminated product was the extent of the problem. Additionally, the TGA is considering Alphapharm Pty Ltd’s RANI 2 ranitidine TGA Laboratories had adapted a US FDA suspending the registration for products 150mg (as hydrochloride) tablet blister test method using LC-HRMS (liquid chro- which cannot demonstrate adequate pack, with one batch found to contain matography with high resolution mass safety and quality. 14ppm NDMA, over 46-times above the spectrometric detection) to test for NDMA While the additional risk of cancer 0.3ppm limit. in the samples, the agency explained. posed by the levels of NDMA identified

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All TGA-Tested Ranitidine Products With A Level Of NDMA Above Acceptable Range NUMBER RANGE OF PPM NDMA PRODUCT SPONSOR OF BATCHES IN TESTED BATCHES TESTED RANI 2 ranitidine 300mg (as hydrochloride) tablet blister pack Alphapharm 16 0.3 to 5.4 RANI 2 ranitidine 150mg (as hydrochloride) tablet blister pack Alphapharm 16 0.5 to 14 APO-RANITIDINE ranitidine 150 mg (as hydrochloride) tablet blister pack Apotex 8 0.4 to 2.2 APO-RANITIDINE ranitidine 300mg (as hydrochloride) tablet blister pack Apotex 7 0.5 to 2.1 APOHEALTH RANITIDINE ACID & HEARTBURN RELIEF 150 mg (as hydro- Apotex 4 0.3 to 1.6 chloride) tablet blister pack APOHEALTH RANITIDINE ACID & HEARTBURN RELIEF EXTRA STRENGTH 300 Apotex 4 0.3 to 5.3 mg (as hydrochloride) tablet blister pack AUSRAN ranitidine 150mg (as hydrochloride) tablet blister pack Arrow Pharma 4 1.5 to 3.9 AUSRAN ranitidine 300mg (as hydrochloride) tablet blister pack Arrow Pharma 3 0.4 to 3.8 CHEMISTS’ OWN RANITIDINE FORTE ranitidine 300mg (as hydrochloride) Arrow Pharma 2 0.4 to 3.4 tablet blister pack CHEMISTS’ OWN RANITIDINE 150mg (as hydrochloride) tablet blister pack Arrow Pharma 4 2.3 to 3.4 ZANTAC ranitidine 50mg/2mL (as hydrochloride) injection ampoule Aspen Pharmacare Australia 2 0.3 ZANTAC ranitidine 150mg/10mL (as hydrochloride) oral liquid bottle Aspen Pharmacare Australia 3 0.6 to 3.2 ZANTAC ranitidine 150mg (as hydrochloride) effervescent tablet tube Aspen Pharmacare Australia 3 1.1 to 1.2 ZANTAC ranitidine 300mg (as hydrochloride) tablet blister pack Aspen Pharmacare Australia 2 0.7 to 5.1 ZANTAC ranitidine 150mg (as hydrochloride) tablet blister pack Aspen Pharmacare Australia 2 0.5 to 0.7 ZANTAC ranitidine 150mg (as hydrochloride) tablet blister pack Aspen Pharmacare Australia 8 0.5 to 2.0 ZANTAC DOUBLE STRENGTH ranitidine 300mg (as hydrochloride) tablet Aspen Pharmacare Australia 6 0.6 to 2.7 blister pack AMCAL HEARTBURN RELIEF EXTRA STRENGTH ranitidine (as hydrochloride) Cipla Australia 1 3.6 300mg tablet strip pack PHARMACY ACTION Heartburn & Acid Indigestion Relief ranitidine 150mg Generic Health 2 1.0 to 1.2 tablets (as hydrochloride) blister pack PHARMACY ACTION Heartburn & Acid Indigestion Relief Forte ranitidine Generic Health 1.6 (as hydrochloride) 300mg tablet blister pack MEDIX HEARTBURN & ACID INDIGESTION ranitidine hydrochloride 167.5 Nova Pharmaceuticals 1 0.5 mg tablets blister pack COLES HEARTBURN & ACID INDIGESTION ranitidine 150 mg Nova Pharmaceuticals 1 0.8 (as hydrochloride) tablet blister pack RANITIDINE SANDOZ ranitidine 300mg (as hydrochloride) tablet Sandoz 2 0.3 blister pack RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet Sandoz 1 0.4 blister pack PHARMACY HEALTH REFLUX RELIEF EXTRA STRENGTH ranitidine Soul Pattinson Manufacturing 1 1.4 (as hydrochloride) 300 mg tablet blister pack PRICELINE PHARMACY REFLUX RELIEF EXTRA STRENGTH ranitidine Soul Pattinson Manufacturing 2 0.4 to 1.0 (as hydrochloride) 300 mg tablet blister pack TERRYWHITE CHEMMART HEARTBURN RELIEF EXTRA STRENGTH ranitidine Soul Pattinson Manufacturing 1 1.8 (as hydrochloride) 300 mg tablet blister pack PHARMACY CHOICE ACID & HEARTBURN RELIEF ranitidine Symbion 1 3.1 (as hydrochloride) 150mg tablets blister pack PHARMACY CHOICE ACID & HEARTBURN RELIEF EXTRA STRENGTH Symbion 1 0.4 ranitidine (as hydrochloride) 300 mg tablet blister pack Source - TGA

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to date in ranitidine products was considered to be very low, TGA Meanwhile in Europe, the EMA has launched a review of raniti- said it set “very high standards for safety in medicines.” dine but is yet to publish any initial findings. Separate from that In the US, the FDA is continuing to use liquid chromatography- review, the EMA has asked marketing authorization holders to re- mass spectrometry testing to detect and quantify NDMA in ra- view all products containing chemically synthesized active phar- nitidine. Earlier this month the agency said that its “early, limited maceutical ingredients for the possible presence of nitrosamines testing has found unacceptable levels of NDMA in samples of ra- and test all products at risk. (Also see “EMA Tells Firms To Evaluate nitidine.” (Also see “Testing Ranitidine With Too Much Heat Could OTCs For Carcinogenic Nitrosamines” - HBW Insight, 27 Sep, 2019.). Generate NDMA, FDA Says” - HBW Insight, 2 Oct, 2019.) Published online 30 October 2019 Asbestos In Johnson’s Baby Powder May Come From Test Labs, J&J Says

MALCOLM SPICER [email protected]

sbestos contamination in a room used by a laboratory Johnson & AJohnson hired to test samples from a recently recalled lot of Johnson’s Baby Powder shows that false positive results can occur, J&J says. The New Brunswick, NJ-based firm on 29 October stated that no asbestos was found in 15 tests from the same bottle of Johnson’s Baby Powder that the Food and Drug Administration previously tested and reported the presence of asbestos. J&J also said another 48 laboratory tests by two third-party laboratories of samples from the single lot of the product it recalled on 18 October also found no asbestos. The tests, using transmission electron microscopy, powder x-ray diffraction and polarized light microscopy methods, were part of an investigation it started following the FDA’s finding. However, the global consumer health, pharmaceutical and medical technology The firm says the “finding underscores survey of cosmetic products for asbestos it giant also stated that one of its contrac- the importance of investigating any posi- started in 2018 involves testing of around tor’s testing processes demonstrated that tive test result.” It notes that the American 50 cosmetic products. (Also see “J&J Starts findings of asbestos in a product can be Society for Testing and Materials identifies First Baby Powder Recall Linked To Asbestos influenced by factors including the test- contamination as a concern in asbestos Finding “ - HBW Insight, 18 Oct, 2019.) ing environment. analysis as asbestos contamination may J&S says one of the third-party laborato- be introduced during sample division, Published online 30 October 2019 ries used an auxiliary room during testing, storage, preparation and analysis. which “deviated from its normal protocol.” The Johnson’s Baby Powder recall an- While samples tested in the firm’s stan- nounced on 18 October is limited to one dard room were determined to be asbes- lot of the product in 22-ounce contain- tos-free, three of the five samples tested ers, which some retailers also are remov- in the auxiliary room showed positive ing from their shelves. The firm identified LET’S GET results. However, the laboratory deter- the contamination at no greater than mined a portable air conditioner in use 0.00002% in samples from a single bottle SOCIAL in the room during the sample prepara- purchased from an online retailer. FDA’s @HBWInsight tion was contaminated with asbestos, announcement of the recall stated the according to J&J. agency tested a J&J product in its ongoing

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National Toxicology Program: Oxybenzone Shows ‘Equivocal Evidence Of Carcinogenic Activity’ LAUREN NARDELLA [email protected] RYAN NELSON [email protected]

he National Toxicology Program identified “equivocal evidence of T carcinogenic activity” in rats exposed to 2-hydroxy-4-methoxybenzophe- none (HMB), or oxybenzone, according to a draft reportreleased in October. While hardly a red flag, the tenta- tive finding could drive additional research into oxybenzone’s carcinogenic potential – as publicly available literature on the subject is limited – and provide fodder for campaigns against the ingredient at a time of growing regulatory scru- tiny around the US. The National Cancer Institute nomi- nated oxybenzone for NTP review, as part of the latter’s Technical Report series, due of the positive testing spectrum that, ac- for bans or tighter restrictions on oxy- to widespread consumer exposure to the cording to the NTP, indicates a possible benzone use in sunscreens and other substance through sunscreen products human hazard. personal-care products. and a general lack of publicly accessible The NTP notes that human risk determi- Florida’s legislature, for example, will carcinogenicity data. nations are beyond the scope and intent be reconsidering a proposal in 2020 to According to the draft report, an- of its Technical Reports. prohibit the non-prescription sale of nounced in the Federal Register on 11 Organizations such as the International oxybenzone-containing sunscreens state- October, the NTP orally exposed groups Agency for Research on Cancer, part of wide. (Also see “Oxybenzone Sunscreen of rats and mice to oxybenzone in doses the United Nations’ World Health Organi- Remains Live Issue As Florida Lawmakers of 1,000, 3,000 or 10,000 parts per million zation, take NTP studies into account in Lay Groundwork For 2020” - HBW Insight, over a two-year period for comparison wider analyses aimed at characterizing 26 Oct, 2019.) against control groups. human cancer risks. While the driving impetus behind the Investigators observed brain and spinal IARC’s classifications can have regula- Florida bill is oxybenzone’s feared threat cord malignant meningiomas in male rats tory implications in the US. For example, to local coral, advocates of oxybenzone and increased incidence of thyroid C-cell “sufficient evidence” of a substance’s bans frequently cite human health con- adenomas and uterine stromal polyps in carcinogenicity in experimental animals, cerns as well. female rats, leading to the study’s “equivo- earning a Group 2B categorization from Meanwhile, the US Food and Drug Ad- cal evidence” conclusion. IARC, triggers listing under California’s ministration tentatively designated oxy- Both rats and mice showed increased Prop 65 regulation. benzone as Category III (needs additional incidence of non-neoplastic lesions ver- The NTP’s draft report on oxybenzone data) in a February proposed rule to es- sus controls, but there was no evidence will undergo evaluation by a peer review tablish a final OTC sunscreen drug mono- of carcinogenic activity in the mice, the panel on 12 December. Interested parties graph, which is due by the end of Novem- report notes. can register by that date to view the meet- ber under the Sunscreen Innovation Act. On the NTP’s carcinogenic evidence ing via webcast, or by 3 December to pres- The agency appears ready to defer final scale, equivocal evidence – as opposed ent oral comments. rulemaking on oxybenzone and seven to “clear evidence” and “some evidence” Written comments must be submitted other chemical UV filters proposed as – is “demonstrated by studies that are in- to the NTP by 20 November. Category III, provided that industry’s work terpreted as showing a marginal increase plan for the ingredients, submitted in of neoplasms that may be chemical- WEAK SIGNALS, POTENTIALLY mid-September, proves acceptable. (Also related,” says the inter-agency program NOTABLE IMPLICATIONS see “Sunscreen Industry’s Plan For First In- run by the US Department of Health and Notwithstanding the relative weakness gredient MUsT Estimates 2023 Completion” Human Services. of carcinogenic signals in the NTP’s ro- - HBW Insight, 24 Sep, 2019.) Far from anything definitive, the equiv- dent study, NGOs and policymakers Industry’s strategy focuses on gener- ocal designation falls on the lower end could seize on the report to push harder ating maximal usage trial (MUsT) data

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requested by the FDA to gauge the The FDA identified all of those end- Should industry MUsTs demonstrate systemic absorption rates of sunscreen points in its proposed sunscreen rule as negligible bioavailability of UV filters at active ingredients, an issue of growing insufficiently addressed by data in the maximal usage conditions, the systemic concern as sunscreen use has increased public domain. toxicity data required for GRASE determi- in recent decades and science has Regarding oxybenzone specifically, the nations could be relatively minimal. emerged suggesting dermal penetra- agency stated, “The available literature in- On the other hand, if studied sun- tion potential. cludes studies indicating that oxybenzone screen active ingredients are shown to Under the plan outlined by the Per- is absorbed through the skin to a greater absorb at levels of concern to the FDA, sonal Care Products Council, a pivotal extent than previously understood and industry’s fight to maintain current MUsT for industry’s first selected UV filter can lead to significant systemic exposure.” GRASE designations and reliant sun- would not be completed until 2023, with The FDA continued, “We expect that a screen products’ OTC availability could additional MUsTs to follow for remain- positive GRASE finding for oxybenzone- be compounded significantly. ing active ingredients prioritized by the containing sunscreens would require, Naturally, industry will continue to ad- trade group’s base. among other things, both a MUsT show- vocate assessments that weigh any UV In the interim, PCPC intends to compile ing the degree of oxybenzone absorp- filter hazards against sunscreen products’ clinical data from its members, to date un- tion under maximal usage conditions and skin cancer-prevention benefits, as the available to the FDA, regarding sunscreen DART studies that fully investigate its po- FDA and dermatologists continue to rec- ingredients’ dermal safety, as well as non- tential endocrine-disrupting effects. We ommend sunscreen use as part of con- public, non-clinical studies related to UV found neither in the existing record. The sumers’ sun-safety strategies. filters’ carcinogenicity and developmental record also lacks systemic and dermal car- and reproductive toxicity (DART). cinogenicity studies for oxybenzone.” Published online 30 October 2019 Oxybenzone Sunscreen Remains Live Issue As Florida Lawmakers Lay Groundwork For 2020

LAUREN NARDELLA [email protected]

2019 meeting, SB 708, which did not advance out of committee and ultimately was withdrawn from consideration in April as the session winded down. Similar to Hawaii and other jurisdictions that already have en- acted laws or ordinances banning oxybenzone/octinoxate-containing sunscreen sales, the driving concern in Florida is the UV filters’ impacts on coral health. (Also see “Hawaii’s Sunscreen Ingre- dient Ban Is On The Books; To Industry, An Affront To Science” - HBW Insight, 7 Jul, 2018.) “Thriving coral reefs are critically important, especially here in Florida,” Stewart states in a 16 October release, adding, “Not lorida may be a battleground in 2020 over sunscreens only do they act as a water filtration system and habitat for fish containing active ingredients linked to environmental ills, reproduction, they offer protection against storm surge and Fwith a legislative proposal already in the queue to ban the coastline erosion.” products’ sale. The limited science linking sunscreen active ingredients to ad- The state’s legislature does not reconvene in full until 14 Janu- verse coral effects is contentious, and industry maintains that the ary 2020, but interim committee meetings have commenced, and real culprit in coral declines is climate change, combined with ag- bills are being drafted already in advance of the next session. ricultural and industrial pollution on a far grander scale compared Filed on 17 September and referred to the Florida Senate’s En- with sunscreen washing off swimmers. vironment and Natural Resources, Commerce and Tourism, and “By supporting misguided bans on the sale and use of these Rules committees, SB 318 from Sen. Linda Stewart, D-Orlando, sunscreens, policymakers are diverting people from finding real would prohibit the sale or distribution of sunscreens formulated solutions while jeopardizing public health,” asserts Jay Ansell, vice with oxybenzone and/or octinoxate, beginning 1 July 2020. president of cosmetic programs at the Personal Care Products The sole exception would be in cases where consumers have Council, in a 16 September post. prescriptions from licensed medical professionals, presumably Stewart insists that Floridians have plenty of alternative sun- requiring the products to be kept behind pharmacy counters. screens to choose from, citing just zinc oxide as a preferred UV Stewart introduced a similar proposal in the Florida legislature’s filter but holding that many “reef-friendly” options not only are

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better for the environment but also “superior” when it comes to Should SB 172 pass in 2020, preempting sun protection, with less potential for sensitization or irritation. In response to media reports that have “mischaracterized” her local OTC drug regulations that conflict proposed bill, the senator emphasizes in her release that SB 318 is not designed to discourage sunscreen use. with state law, the marketability of “I agree with doctors about the short- and long-term benefits of wearing sunscreen and encourage everyone to do so,” Stewart says. oxybenzone/octinoxate-containing sunscreens across Florida, including ALSO UP FOR DEBATE: PREEMPTING LOCAL BANS Florida tourism hub Key West already has banned the sale of in Key West, could be dictated by the oxybenzone- and octinoxate-containing sunscreens starting in 2021, and similar proposals have arisen in other Sunshine Stewart bill’s fate. State cities. (Also see “Key West Bans Purported Coral-Killing Sun- screens, With Florida-Wide Proposal Now On The Table” - HBW In- sight, 6 Feb, 2019.) Republican lawmakers at the state level have shown interest in awaits consideration by the Innovation, Industry and Technol- curtailing local prohibitions that conflict with Florida law. ogy Committee. In the 2019 session, Sen. Travis Hutson, R-St. Augustine, cham- Should SB 172 pass in 2020, the marketability of oxybenzone/ pioned legislation to bar local governments from adopting or en- octinoxate-containing sunscreens across Florida, including in Key forcing regulations related to over-the-counter drugs or cosmet- West, could be dictated by the Stewart bill’s fate. ics before 1 July 2021. Oxybenzone is one of eight chemical UV filters that industry The state senator indicated to media sources that his objective aims to back as generally recognized as safe and effective (GRASE) was to buy time in order to gain perspective on the environmental following a proposed rule from the US Food and Drug Adminis- issues driving local action. At the time, Miami Beach also was con- tration in February that identified safety data gaps, putting their sidering a Key West-style ban. (Also see “Sunscreen Industry Finds future OTC use in question nationwide. (Also see “Sunscreen In- Ally In Florida State Senator Hutson; SB 588 Would Ban Local Bans” dustry’s Plan For First Ingredient MUsT Estimates 2023 Completion” - HBW Insight, 4 Apr, 2019.) - HBW Insight, 24 Sep, 2019.) Hutson’s SB 588 skated through the Commerce and Tourism The FDA seems satisfied with data supporting the historical and Community Affairs committees, with just one “nay” vote reg- GRASE status of titanium dioxide and zinc oxide. However, emerg- istered, before dying in the Rules Committee. ing research, driven by widespread public interest of late in sun- Sen. Rob Bradley, R-Fleming, has revived the concept for the screen safety issues, could give environmental advocates reason to 2020 session, and his bill, SB 172, calls for a permanent end to local level their sights on mineral sunscreen use as well. (Also see “Miner- regulations concerning OTC drugs or cosmetics that differ from al Sunscreens Threaten Marine Ecosystems? L’Oreal Hair Care Built On statewide rules. Stolen IP? Personal Care News In Brief” - HBW Insight, 26 Aug, 2019.) The bill already has been deemed favorable by the Florida Senate’s Community Affairs Committee by a 3-1 vote, and now Published online 28 October 2019 Coty Would Shrink By A Third With Professional, Brazil Biz Divestures; Analysts React

RYAN NELSON [email protected]

oty Inc. is exploring a possible sale of its Professional Beau- as well as Wella and Clairol retail lines. All were brought on board ty business and Brazilian operations in a further show that in October 2016 as part of Coty’s roughly $12m merger deal with Cthe firm may have bit off more than it could chew with a Procter & Gamble Co. That transaction took some 15 months to com- series of hefty acquisitions in recent years. plete, and Coty has struggled since to integrate and restart acquired “Today’s announcement accelerates [our] transformation and brands, finally announcing a related $3bn impairment charge in July will help reposition Coty as a more focused and agile company, in conjunction with its launch of a four-year turnaround plan. deleverage our balance sheet, and improve our ability to invest in “Styling made easy” brand GHD, acquired in late 2016 for areas with the greatest growth potential,” states CEO Pierre Lau- £420m, also could be up for grabs, along with OPI salon nail care, bies in the firm’s release. which has been part of Coty’s portfolio since its November 2010 Items on the chopping block ostensibly include professional hair- purchase of the brand for a reported $1bn. care brands Nioxin, Sebastian Professional, Sassoon Professional, Coty’s Brazil business includes a range of cosmetic and person- System Professional, Wella Professionals and Clairol Professional, al-care brands picked up in November 2015 from Hypermarcas

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S.A. (now Hypera Pharma), also for $1bn. HENKEL CITED AS (Also see “Coty Nabs Brazilian Beauty Biz, Items on chopping POTENTIAL BUYER Unveils Pending Leadership Reorg” - HBW Jefferies analyst Stephanie Wissink calls Insight, 4 Nov, 2015.) block ostensibly include Coty’s announcement a “surprise” in her Both the Brazilian business and Pro- professional hair-care own 21 October note to investors. fessional division – the latter No. 2 in the At the same time, she points out that world for professional hair care, Coty says, brands Nioxin, Sebastian the firm’s Professional and Brazilian busi- with sales of $1.8bn in fiscal 2019 – are de- nesses could be most saleable, given scribed as distinct, standalone units with Professional, Sassoon Consumer Beauty’s eroded value and the their own management structures. Professional, System heavily licensed nature of Coty’s Luxury Legacy P&G managers still run the Pro- business, which could complicate an own- fessional business, according to analysts. Professional, Wella ership change. Together, the prospective divestitures Professionals and Clairol Both Wissink and Alwy speculate that represent $2.7bn in net revenues, or Henkel AG & Co. KGaA could be interested approximately a third of Coty’s overall Professional, as well as in Coty’s hair-care assets under review. business. Alwy notes that Henkel already at- Coty expects its strategic review pro- Wella and Clairol retail tempted to acquire Wella in 2003 but was cess to be completed by summer 2020. lines. All were brought outbid by P&G. Going forward, the firm aims to focus The German firm tried again in 2015 but more intently on fragrance (eg, Gucci, on board in 2016 as part lost out to Coty, she points out. Burberry, Hugo Boss and Calvin Klein li- of Coty’s roughly $12m Further, Henkel’s Beauty Care business censes), color cosmetics (CoverGirl, Max – its smallest after Adhesive Technologies Factor, Rimmel and Sally Hansen) and skin merger deal with P&G. and Laundry & Home Care – is struggling. care (philosophy and Lancaster) within its The division performed below expecta- Luxury and Consumer Beauty segments. tions in the firm’s fiscal 2019 second quar- area of skin care specifically. “We worry, ter, reported in August, booking roughly CLEARING THE WAY FOR KYLIE? however, this announcement will result €1bn in sales, down 3.2% nominally or Analyst reactions to the news were mixed. in a deterioration of trends while a po- 2.4% in organic terms. On the one hand, experts have been tential transaction is pursued, as we’ve An influx of fresh assets could be skeptical of Coty’s ability to pay down seen in multiple other situations,” she what’s needed to jumpstart the unit, debt while simultaneously improving says in a same-day note. Alwy suggests. fundamentals to drive sustainable growth Morningstar analyst Rebecca Scheun- The analyst points out that Henkel – across its sprawling business. eman raises another possibility that she which owns the Schwarzkopf, Sexy Hair However, analysts also see the busi- views as potentially problematic – that and Alterna brands – has performed well nesses under review as relatively stable paring down its business will better en- in professional hair care in recent years in ones with favorable margins, particularly able Coty to pursue a majority stake in a difficult climate. when compared with Consumer Beauty’s Kylie Jenner’s Kylie Cosmetics business. Henkel’s Beauty portfolio also includes volatility of late. There were rumors over the summer that Dial cleansing and skin-care products and Coty’s Consumer Beauty sales fell 17% the two are engaged in discussions about Right Guard deodorants and shower gels. in fiscal 2019, reported, versus a roughly such a deal to the tune of $600m. Wissink lists Natura & Co. – currently in 5% decline in Professional Beauty sales. “We think it is difficult to build sus- the process of acquiring Avon Products (Also see “Coty Elevates Advertising Over tained brand strength for celebrity Inc. – among potential buyers of Coty’s Promotion In Consumer Beauty Reboot” - brands, as their popularity tends to ebb Brazilian business. Local Brazilian players HBW Insight, 29 Aug, 2019.) and flow with the popularity of the ce- also could take an interest and/or a mul- Deutsche Bank’s Faiza Alwy believes lebrity. In addition, we assign Coty a Poor tinational home and personal-care firm the potential divestiture could provide stewardship rating because of its track with limited penetration in Brazil. Coty with the greater flexibility it needs to record of value-destroying acquisitions,” execute on strategic growth goals in the Scheuneman says. Published online 24 October 2019

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Monat Can’t Shed Class Action Linking Its Products To Hair Loss RYAN NELSON [email protected]

onat Global Corp. remains optimistic about its ability to The company, which sells its products through its website as defeat a proposed class action in Florida federal court well as independent sales representatives called Market Partners, Mregarding the marketing and safety of its anti-aging also claims in marketing materials that its products are FDA-ap- hair-care products, despite largely failing to dismiss the suit on proved, “naturally based” and suitable for all hair and skin types, 23 October. plaintiffs note. “This is just a small part of a lengthy legal process. We look for- Complaints about Monat and its products have piled up since ward to taking discovery, including depositions of each of the the company’s launch in late 2014. plaintiffs, to determine the real cause of their claimed reactions,” “It is telling that Monat, which has only been in existence for four states Monat’s Senior VP and Chief Legal Officer Thomas Hoolihan years, is reported to have the second-largest number of complaints in a next-day release. about a single hair-care brand in the history of the 112-year old FDA,” He adds, “We are confident that those depositions, and other dis- the plaintiffs state in an amended complaint filed in December 2018. covery, will confirm what we already know: MONAT products are They continue, “In roughly a two-year timespan, certain users of dermatologist-tested, made with the highest quality ingredients, Monat Products have taken the time to make nearly 1,000 adverse meet or exceed all safety and quality standards set by our industry, reports to the FDA and the Better Business Bureau, combined. and are validated by rigorous safety testing conducted by inde- Additionally, the internet is replete with heartbreaking stories of pendent labs.” Actions brought against Monat by 18 plaintiffs – all many others who have been harmed by Monat Products.” of whom claim to have suffered hair loss, scalp irritation and other The case compares to that of WEN by Chaz Dean, Inc., which adverse effects after using Monat hair-care products – were con- reached a roughly $27m settlement in 2016 with consumers who solidated in Florida’s Southern District, Miami Division, in June 2018. claimed to have lost their hair or sustained other injuries after us- The plaintiffs say their experiences were unexpected given that ing WEN Cleansing Conditioners. Monat promotes its offerings as capable of regrowing hair and That settlement enabled class members to file claims in accor- preventing hair loss, including by reducing “the production of the dance with a tiered system, contingent on the severity of their in- [DHT] hormone that contributes to hair loss.” juries and the level of evidence submitted.

Unilever’s Stain-Resistant Black + White Antiperspirant Is Falsely Advertised – Class Action Unilever PLC’s Degree MotionSense UltraClear Black + White formulated with a reduced concentration of active ingredient Dry Spray Antiperspirant, marketed as “anti yellow stains & aluminum chlorohydrate – 20.2% versus 23.3% in regular De- white marks sweat protection,” is simply a diluted version of gree MotionSense. another MotionSense product that causes the very problem it “Thus, when Defendants further state on their website that ‘[t] claims to solve, plaintiff Carla Been alleges. here’s no compromise on sweat and odor protection, either,’ Been filed a proposed class action on 4 October in St. Louis Mis- that is also a complete falsehood,” Been says. souri Circuit Court that has since been removed to Missouri’s More problematic, she says, is the “well-accepted” fact that yel- Eastern District, citing violations of false advertising and con- low stains and white marks on clothing are caused by the alu- sumer protection statutes, breach of warranty, breach of im- minum in antiperspirants. plied contract and unjust enrichment. “Thus, regardless of the extent, the Product causes, at least indi- She seeks to represent a nationwide class of similarly situated rectly, the exact condition – ‘staining’ and/or ‘white marks’ – that consumers and a Missouri subclass. it purports to be ‘anti’ toward and ‘help to reduce,’” Been says. According to the plaintiff, UltraClear Black + White is decep- Priced the same as the regular Degree MotionSense antiperspi- tively marketed as having a formula that “helps to reduce white rant, UltraClear Black + White is marketed in a way that “mislead[s] marks on … dark clothes, and yellow ones on … white.” and deceiv[es] the buying public into paying the same amount In reality, she says, the product contains the same ingredients for an inferior product while under the false impression that it is as regular Degree MotionSense Dry Spray Antiperspirant, with somehow superior,” according to her complaint. nothing added to address the staining problem. Been seeks restitution, compensatory and punitive damages, The one material difference is that UltraClear Black + White is costs and fees.

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It appears that the plaintiffs against Monat may be angling for a dergo proper quality checks, as evidenced by the US Food and similar resolution, alleging that they incurred both physical and eco- Drug Administration’s findings during an inspection of the nomic harm as a result of the firm’s false and misleading messaging. company’s Cutler Bay, FL-based facility in March 2018. They cite violation of Florida’s Deceptive and Unfair Trade Prac- Third, Monat was aware of reports of hair loss and other injuries tices Act, violation of the Magnuson-Moss Warranty Act, breach but failed to communicate those risks to consumers, according to of implied and express warranty, negligence, strict liability, unjust the plaintiffs. enrichment and, in the alternative, violations of various state con- In fact, the company obscured the risk of harm by telling consumer protection laws. sumers to expect certain adverse effects as normal aspects of an The plaintiffs seek a full range of relief, including compensatory initial “detoxifying” phase of Monat product use, a concept that damages, disgorgement, punitive damages, injunctive and de- company leadership later acknowledged was not scientifically claratory relief, and attorneys’ fees and costs. supported, the plaintiffs say. Gayles ruled that all such liability allegations are sufficient -un ‘DEFECT’ SUFFICIENTLY PLED FOR NOW der federal rules to survive a motion for dismissal. Factual ele- Monat entered a motion in February to have the complaint ments disputed by Monat, such as the safety of its ingredients, will thrown out, but was successful only in dismissing plaintiffs’ claim not be explored in greater depth until later stages. for injunctive relief. The judge noted a challenge the plaintiffs may face down US District Judge Darrin Gayles determined that the plaintiffs the line. “Plaintiffs might have a difficult time proving that adequately alleged a product defect to the extent required at this the Products, and not a pre-existing medical condition or stage in the litigation. According to the plaintiffs, the Monat prod- simple aging, caused their injuries. But, at this stage of the ucts in question are defective in their design, manufacture and litigation, Plaintiffs’ allegations are sufficient to establish warnings (or lack thereof). causation,” he says. First, the products contain ingredients such as cocamidopropyl Monat, which launched its first skin-care products in Septem- betaine, benzyl alcohol, red clover leaf extract, butylene glycol and ber, maintains that safety is its top priority. sulfates, which are known to cause allergic reactions and dermatitis, “The company invests millions of dollars in research and con- the plaintiffs assert. They also locate a defect somewhere in the four ducts thousands of tests each year to ensure MONAT products trademarked ingredients common to each of the firm’s named treat- meet the highest standards for quality, safety and performance,” ment systems – Procataline, Rejuvenique, Capixyl and Crodasorb. says Monat, a subsidiary of Alcora Corporation, in its release. Second, the plaintiffs say, the products were manufactured in unsanitary conditions from raw materials that did not un- Published online 28 October 2019 P&G Extends Secret Line With Essential Oils, Challenges ‘Sweat’ With Old Spice

EILEEN FRANCIS [email protected]

rocter & Gamble Co. says it’s packing beauty and brawn into the latest addition to its Secret underarm brand, a four-product Plineup containing essential oils that fights odors for 48 hours. The launch of Secret with Essential Oils is supported with an ad campaign featuring actress Camila Mendes and running now, at the same time the firm is beefing up promotions for its Old Spice men’s range of deodorants in ads featuring National Football League player Montez Sweat. The new Secret collection contains aluminum zirconium tetrachlorohydrex glycine 15%. Product packaging states the formula Secret with essential oils contains aluminum zirconium can protect against odor for 48 hours, a claim made also on packag- tetrachlorohydrex glycine 15%. ing of Secret Clinical Strength antiperspirant, which launched earlier this year, containing aluminum zirconium trichlorohydrex 20%. Available exclusively in Target in invisible solid form featuring “While antiperspirant has typically been viewed as a more func- on labeling “48 HR invisible solid,” the line will launch nationally in tional product, we are challenging that notion with the launch of 2020, P&G says. Secret with Essential Oils,” the firm says in a recent release. The line The line comprises four essential oil combinations: Coconut Oil is the first antiperspirant that “truly sits between the beauty and + Mandarin, Lavender + Eucalyptus, Rose + Charcoal and Cedar- personal care aisle and reframes what to expect from an under- wood + Citrus. Like Secret Clinical Strength, it’s priced at more arm product.” than double other Secret offerings, $11.99 for 2.6 ounces. Secret’s

hbw.pharmaintelligence.informa.com 4 November 2019 | HBW Insight | 15 BEAUTY (COSMETICS)

regular antiperspirant products and its natural position, aluminum-free version retail for $4.99 for 2.4 ounces. Secret with Essential Oils is supported with a 30-second “You Got This” national ad featuring Mendes, an actress on the CW network teen drama, “Riverdale.” In the ad, Mendes gives herself a pep talk while looking in a mirror. “Okay girl, you got this. No one’s going to see you sweat. You can be feminine and fierce. Low-key and all done up.” The spot ends with the tagline, Tongue-in-cheek print, digital “All Strength. No Sweat.” and TV old spice ads featuring P&G recently brought its Secret brand nfl player montez seat make advertising in-house but uses outside light of NFL players perspiring. agency Berlin Cameron for spots asso- ciated with its partnership with the US Women’s National Soccer Team. In a cam- Tongue-in-cheek print, digital and TV Strongest Swagger debuted as part of paign launched in February, “All Strength, ads make light of NFL players perspiring. Old Spice’s Hardest Working collection in No Sweat,” the Secret advertising team In a 15-second TV spot, a sportscaster an- 2016. (Also see “Old SpiceHardest Work- produced spots in less than a month, nounces the team’s pick of Sweat in the ing Campaign Reflects P&G Focus On Core compared to average production of three April 2019 draft before a voiceover states, Brands” - HBW Insight, 4 Feb, 2016.) to five months. “Sweat … in the NFL? Not on our watch,” Secret and Old Spice are part of P&G’s The Cincinnati-based from has said Se- and the screen shows a stick of Old Spice beauty business, which recorded organic cret advertising will serve as a model for Stronger Swagger antiperspirant. sales growth of 10% (net sales growth of all its brands. The nimbler approach allows On side-by-side billboards, includ- 8%) to $3.56bn in its fiscal year 2020 first the firm to create ads quicker than in the ing two near the team’s stadium, P&G quarter, reported 22 October. The per- past and at a tenth of the cost. shows a container of Old Spice Stron- formance was attributed to investments ger Swagger next to the text, “Say No To and pricing increases, as well as strong OLD SPICE CHALLENGES ‘SWEAT’ Sweat In The NFL.” A photo of the back sales of the SK-II skin care brand. (Also see P&G also is supporting its Old Spice men’s of Sweat’s jersey, including his name, “P&G Raises Guidance On Strong Q1 With antiperspirant/deodorant range, which is positioned for the word “sweat” in Analysts Anticipating Headwinds “ - HBW is the “Official Anti-Perspirant of the NFL,” the text. An adjacent billboard shows Insight, 22 Oct, 2019.) with a campaign featuring Sweat, a rookie Sweat saying, “Old Spice, Sweat is just linebacker for the Washington team. my name.” Published online 28 October 2019 � WELLNESS� UK Weight Loss Claims Sell Sex Appeal But Regulator Isn’t Buying

MALCOLM SPICER [email protected]

sing attractive, thin female enter- following complaints about the firms’ so- tainers to promote weight loss cial media advertising seen in March. Usupplements makes the wrong For Protein Revolution’s V24 Gummies, impression as consumers would expect to UK TV personality Georgia Harrison posted resemble them by using the products af- on her Instagram account: “They’re deli- ter losing weight, says the UK Advertising cious and when taken with water they sup- Standards Authority. press your hunger cravings. Which is critical Instagram posts for glucomannan to stay on diet ... They Contain [sic] gluco- supplements marketed by both Protein mannan which is clinically proven to help Revolution Ltd. and BoomBod Ltd. also with weight loss. You have to try them.” didn’t state a claim for the ingredient as it Katie Price’s and lauren Getzger’s instagram One of the two celebrities posting on In- was authorized to be used, the ASA stated posts for boombod prompted complaints stagram for Boombod’s namesake supple- in separate reports published 23 October to ASA. TURN TO PAGE 18

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CONTINUED FROM PAGE 16 ments, Katie Price, posted: “Getting loads of questions about the @boombod program and how I like it, and it’s no secret. I can’t get enough of it! Quick & Easy weight loss is great, but doing it Georgia Harrison posted on her in a healthy way is key. These shots have a bunch of vitamins, use Instagram account that V24 a clinically proved natural fibre, contain zero laxatives and most gummies are “delicious and importantly … they give results EVERY time!” when taken with water they Bravo for Harrison, Price and Boombody’s second Instagram suppress your hunger cravings.” poster, Lauren Goodger, says the ASA. But not for the target market for the products. “It was clear from the ads that Georgia Harrison did not need to lose weight in order to achieve a healthy weight,” but the overall message of Harrison’s posts “was that she nevertheless used the claim, and none of the posts included information that would product on an ongoing basis to help her limit her calorie intake,” make clear how glucomannan should be used for beneficial ef- the independent agency with authority to enforce the UK’s adver- fect. That would be daily intake of 3 g of glucomannan in three tising regulations said. 1-g doses, together with one to two glasses of water, before “We were concerned that this created the impression that it was meals and in the context of an energy-restricted diet, accord- necessary or advisable for those who aspired to her body shape ing to the ASA report. and lifestyle to use products that suppressed their appetite,” the Protein Revolution, of the Isle of Wright, England, made health ASA added. claims for V24 Gummies including “help keep hunger and crav- It made a similar observation about Price’s and Goodger’s ings at bay through the natural plant extract glucomannan” and Boombod pitches. “Because the ads presented both influencers “great at helping you loose [sic] weight,” “contain glucomannan as aspirational figures, we were concerned that this created the which is clinically proven to help with weight loss.” impression that it was necessary or advisable for those who were For its supplement, Boombod, of Epping Forest near London, already slim to use products that suppressed their appetite to made health claims including “Weight Loss,” “Stop Cravings” and quickly lose weight, which we considered was an irresponsible “banish naughty craving,” while referring in the ads to the prod- message in an ad for an appetite suppressant.” uct as “weight loss shot drink sensation” would be interpreted by consumers “to mean that the product was able to help consumers CLAIMS ALSO NIXED achieve weight loss in a unique, or particularly effective, way,” the ASA advised both firms that the source of health claims for ASA stated. food authorized in the UK, the European Union Register, allows Additionally, Boombod tripped over the UK prohibition against the claim, “Glucomannan in the context of an energy restricted claiming a rate of weight loss linked to a food or dietary ingredient diet contributes to weight loss” and limits its use to food or with claims “weight loss in a week” and “7 day achiever,” according supplement products which contain 1 g of glucomannan per to the report. quantified portion. Both firms, the ASA says, also promoted a dietary product in an None of the celebrity Instragram posts for either product, or irresponsible manner, another violation of UK regulations. other social media posts by the firms stated the claim correctly, or in alternative text that closely tracked with the authorized Published online 23 October 2019 RB Eyes UK VMS Market With Optrex ProVision DAVID RIDLEY [email protected]

eckitt Benckiser Group PLC is ex- see shapes, color and details – healthy, derful complexity” of the human eye, ac- tending its Optrex range in the UK RB continued. As the eye was the “fast- cording to the voice over, by showing the Rwith a new daily eye-care dietary est moving muscle in the human body,” minute movements involved in simple supplement. Optrex ProVision also contained magne- tasks such as focusing on a particular ob- Optrex ProVision – which RB said was sium, RB explained, which contributed ject in a room. launched in Boots pharmacies in August to normal muscle function. Commenting on the strategy behind and would be rolled out to online retail- Optrex ProVision’s launch in the UK was the launch, RB’s Brand Manager for Op- ers “soon” – contained a range of “sci- being supported by 12-week marketing trex in the UK, Sandra Toivo, told HBW entifically proven” ingredients to help campaign, RB said, which aimed to “take Insight that the firm had worked with maintain normal vision. Alongside zinc consumers through the shopper funnel” creative agency Havas over the last few and vitamin B2, lutein and zeaxanthin with a series of innovative videos. years to “really understand our audi- kept the macula of the eye – responsible The first creative featured a giant me- ence and develop a strong brand voice for our central vision which is used to chanical eye, which conveyed the “won- and mission.”

“Our eyes are wonderfully complex, Optrex ProVision dietary supplement ActiMist explains in an innovative way capturing millions of images over our but also by a new campaign for its Op- that we blink up to 60% less when star- lifetime,” she reflected. “One of the small- trex ActiMist Double Action Spray for ing at screens. “Screens, they see you est, yet hardest working parts of the Dry & Tired Eyes. blink less, they see you get screen eyes,” body, the miracle of sight is not lost on Research done by the firm had shown explains the voice over. “Optrex Double the UK public.” that roughly three-quarters of UK con- Action rebalances your eyes’ moisture to However, despite almost two-thirds sumers spent “extended periods of time give tired and dry eyes fast relief at last. of UK consumers claiming they “value looking at a screen,” Toivo reported, with Reset your screen eyes with Optrex.” their sense of sight higher than any other approximately half of respondents to a Echoing the strategy behind the Op- sense,” she continued, new research from survey suffering from tired, itchy or sore trex ProVision launch, Toivo said that RB had shown that British people spent eyes in the last 12 months. the campaign was designed to combat “more money per month on appearance “This is why we have revamped our the relative apathy felt by consum- than in a year on eye care.” Screen Eyes creative,” Toivo said, “giving it ers towards their eyes compared with RB’s mission, therefore, was to “make a new twist, driving relevance also with a other aspects of their health, by in- the UK public care about eye care,” Toivo younger audience.” creasing awareness of screen eyes and insisted. Featuring a young woman with a pic- “hence making Optrex more relevant RB was pursuing this mission not ture of a phone screens stuck over each for them.” only through the launch of the new of her eyes, RB’s new video for Optrex Published online 30 October 2019 Herbalife CEO, President Changes Effective In March erbalife Nutrition Ltd. taps its ex- president and chief strategic officer, will for finance, was chief financial officer for ecutive staff for its next CEO and become president. eight years before being named co-pres- Hpresident 10 months after its for- Agwunobi, a physician, joined Herb- ident and strategy chief in 2018. mer CEO stepped down due to comments alife as health and nutrition chief in In his current posts, he manages that ran afoul of is standards. 2016 and added co-president to his Herbalife’s regional leadership, respon- The Los Angeles-based nutrition and role in 2018. The firm said he led its ef- sible for growing its nutrition business weight loss supplement direct seller on forts in expanding its product portfolio and driving performance in more than 29 October, when it also reported its and strengthening relationships with 94 countries. Michael Johnson, serving third-quarter results, announced that distributors and customers to bring as interim CEO since Richard Goudis on March 30, John Agwunobi will move better nutrition, healthier lifestyles and resigned in January, will continue as to CEO from his current posts of co- entrepreneurial business opportunities board chairman. president and chief health and nutrition to people worldwide. DeSimone joined officer and John DeSimone, currently co- Herbalife in 2007 as senior vice president Published online 29 October 2019

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