Navigating the Regulatory Landscape of Marketing Omega-3 Supplements

July 2013 US$39.00

special report Navigating the Regulatory Landscape of Marketing Omega-3 Supplements Given FDA’s reticence to establish an RDI for omega-3s, as well as its antiquated view of inflammation claims, companies are currently walking a nuanced tightrope to communicate the benefits of omega-3s to consumers while avoiding regulatory enforcement action for their product claims.

by Todd Harrison and Erin Seder Navigating the Regulatory Landscape of Marketing Omega-3 Supplements by Todd Harrison and Erin Seder

mega-3 fatty acid supplementation has a longstanding reputation of improving cardiovascular health, reducing overall inflammation, and O supporting cognitive health and eye function. According to a number of recent studies, it may also help reduce joint stiffness associated with rheumatoid arthritis, lower depression levels, support prenatal health, reduce the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children, and protect against Alzheimer’s disease, dementia and, potentially, cancer. And, according to a market report published by Transparency Market Research, the global omega-3 ingredients demand is expected to cross US$4 billion in 2018, which is an estimated growth of 15 percent from 2013. Considering the significant amount of money and research invested, one would think the dietary supplement industry would have little difficulty navigating the regulatory landscape of marketing omega-3 supplements. However, given FDA’s reticence to establish an RDI for omega-3s, as well as its antiquated view of inflammation claims, companies are currently walking a nuanced tightrope to communicate the benefits of omega-3s to consumers while avoiding regulatory enforcement action for their product claims.

Omega-3 Supplements: A Dense Regulatory Landscape While there is technically no regulatory preapproval or screening process for dietary supplements before they hit the market, FDA has the primary responsibility of overseeing permissible product claims. Among the most commonly used claims are structure/function claims, nutrient content claims and health claims. FDA’s regulation of these claims has literally bound the hands of the omega-3 supplement industry so tightly that consumers are not being told the full gamut of substantial health benefits provided by omega-3 fatty acid supplementation.

Omega-3 Insights • Marketing Omega-3 Supplements 2 omega3insights.com The Structure/Function Claim In general, structure/function claims describe the role of a dietary supplement in the structure and function of human bodies, but the claims may not explicitly or implicitly claim to prevent, treat, mitigate, cure or diagnose a disease. These claims can describe the role of a particular nutrient or dietary ingredient intended to affect normal structure or function in humans. For example, a supplement may claim, “Omega-3 fatty acids help maintain healthy eye, brain and nerve cells,” but it may not claim to “support eye health to treat macular degeneration.” Structure/function claims can also characterize the action by which a nutrient or dietary ingredient maintains such structure or function, or describe a benefit related to a nutrient deficiency Structure/function disease (e.g., vitamin C and scurvy), so long as the statement comments on how prevalent the disease is in the United States. claims describe the General well-being claims are also considered permissible structure/ role of a dietary function claims. Technically, a 30-day post-market notification must be submitted to FDA notifying the agency of a structure/function supplement in the claim’s wording. In practice, however, the industry as a whole does not comply with this requirement, and FDA has generally not raised structure and function this issue in warning letters to companies objecting to whether a of human bodies, but claim is a permissible structure/function claim or an impermissible disease claim. We would note some companies that have filed the claims may not structure/function claims will then tout that FDA approves the claim when it does not receive a letter of no objection. Please note FDA is explicitly or implicitly not reviewing whether a claim is substantiated; rather, it will only claim to prevent, treat, send a letter if it believes the form of the claim (i.e., is it a permissible structure/function claim) is an impermissible disease claim. FDA has mitigate, cure or generally let FTC deal with issues related to claims substantiation. Thus, those companies stating their claims are approved by FDA are diagnose a disease. making a false and misleading claim in and of itself.

Nutrient Content Claims and Health Claims FDA’s notification process allows manufacturers and distributors to use health claims or nutrient content claims in dietary supplement labeling if the claims are based on current, published, authoritative statements from certain federal scientific bodies—and FDA does not object to the claims within 120 days of receipt of the notification. Claims authorized under the notification process may be used until FDA issues a regulation prohibiting or modifying the claim, FDA issues a regulation finding the statutory notification requirements have not been met, or a district court determines the statutory notification requirements have not been met.

Omega-3 Insights • Marketing Omega-3 Supplements 3 omega3insights.com Nutrient content claims characterize the level of nutrients in a product (e.g., “low fat,” “low sodium,” “high protein,” etc.). Generally, nutrient content claims not explicitly authorized by FDA, either by regulation or petition, are prohibited. Because FDA has been remiss to assign an RDI for omega-3 fatty acids, dietary supplement companies have been limited—they may make nutrient content claims so long as the claim specifies only the amount of the omega-3s per serving and does not implicitly characterize the level of the nutrient in the product. For example, the claim “x grams of omega-3 fatty acids” is a permissible nutrient content claim, while “potent source of omega-3 fatty acids” is not. Further, when using the words “contains” or “provides” for nutrients without RDIs, such as omega-3 fatty acids, the specific amount of the nutrient must be stated. Consequently, the claim “contains x grams of omega-fatty acids per serving” or “provides x grams of omega-3s” is permitted. On the other hand, claims The claim “x grams of such as “contains omega-3 fatty acids” and “provides omega-3 fatty acids” are not. omega-3 fatty acids” Befuddling the industry’s understanding of permissible omega-3 is a permissible claims further was FDA’s 2007 issuance of a proposed rule prohibiting the use of most of the then-permissible nutrient content nutrient content claims for omega-3s alpha linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At the time, omega-3 claim, while “potent nutrient content claims were lawfully on the market because FDA source of omega-3 had not objected to three notifications submitted between 2004 and 2006. The notifications proposed “high,” “good source” and fatty acids” is not. “more” claims for ALA, and “high” claims for DHA and EPA. In its 2007 proposed rule, FDA asserted that the nutrient content claims for DHA and EPA that had been submitted in notifications were not based on an authoritative statement that identified a nutrient level to which the claims referred. Therefore, such claims lacked an adequate scientific basis—and the claimed nutrient levels could result in consumer confusion. FDA did, however, leave some nutrient content claims for ALA alone, depending on the amount per product. Six years later, the proposed rule remains just that, proposed.

Qualified Health Claims Health claims discuss the relationship between a nutrient and a disease or disease condition. The claim language, which is specifically approved by FDA and based on significant scientific agreement, is set in stone and may not be changed. Qualified health claims are based on less than scientific agreement, but the claim language discloses the limitations of evidence in support of the claimed relationship.

Omega-3 Insights • Marketing Omega-3 Supplements 4 omega3insights.com In September 2004, FDA published a qualified health claim for reduced risk of coronary heart disease in conventional foods that contain EPA and DHA omega-3 fatty acids. Still in effect, the claim states: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]” To make the omega-3 qualified health claim, the product must meet the “low saturated fat” and “low cholesterol” criteria, and the food must contain at least 10 percent of the Daily Value of vitamin A, vitamin C, iron, calcium, protein or dietary fiber, prior to any nutrient addition. Specified levels of total fat, sodium, What qualifies as cholesterol or saturated fats can also disqualify foods. Moreover, “competent and reliable FDA requires dietary supplements not recommend or suggest in their labeling a daily intake exceeding 2 g of EPA and DHA. scientific evidence”?

Claim Substantiation: Although FTC has What You Don’t Know Can Hurt You published a definition of All advertising claims must be truthful and not misleading, plus supported by competent and reliable scientific evidence. So, what the phrase, it remains qualifies as “competent and reliable scientific evidence”? Although FTC has published a definition of the phrase, it remains anything but clear. anything but clear. FTC defines competent and reliable scientific evidence as tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. As indicated in several recent consent decrees, the definition may include at least two adequate and well-controlled human clinical studies of the product or its substantial equivalent. Factors affecting required levels of substantiation include the type of product, type of claim, context in which the claim is used, benefits of a truthful claim, consequences of a false claim, what qualified experts in the field believe is reasonable, and whether a specific level of support is stated or suggested in the claim. Generally acceptable scientific evidence includes well-controlled double- blind studies, longer-term studies, studies that showed statistically and clinically significant results, and studies published in reputable peer-reviewed scientific journals. The nature and quality of the written report is also important. Evidence that generally does not adequately substantiate marketing claims alone, but still may help support a claim, includes animal studies, in vitro studies, testimonial/ anecdotal evidence, meta-analysis and product monographs.

Omega-3 Insights • Marketing Omega-3 Supplements 5 omega3insights.com Omega-3 claims have become a regulatory focus area for both FDA and FTC, increasing the level of substantiation necessary to make claims generally and structure/function claims, in particular. In 2010, FDA launched a full-court press on omega-3 claims, sending 11 warning letters alleging the target companies were making baseless claims about how omega-3 supplements benefit children’s brain and vision function and development. In these letters, FDA stated that an acceptable substantiation level requires “well-conducted, clinical cause-and-effect studies demonstrating that the use of the combination of omega-3 fatty acids provided in Product X, in the same dosage as provided by one serving of that product, improves or promotes brain function, cognitive function, attention span, intelligence, memory, learning ability, and visual acuity in normal children ages 2 years and older.” Because of their popularity with enforcement agencies, it is imperative that companies marketing omega-3 supplements consider the dose, dosage form, route of administration, formulation, total length of exposure, frequency of exposure and study population when reviewing possible substantiating Omega-3 claims have research. Different omega-3 fatty acids have different functions. So, if you plan to make a brain or retinal development claim, it become a regulatory should be related to DHA, not EPA or ALA. Further, cardiovascular focus area for both FDA claims can only be made in connection with DHA and EPA, but not ALA. Dosage is also key with omega-3 claims, as any dosage and FTC, increasing the under 250 mg is unlikely to substantiate any claims. level of substantiation Omega-3 Inflammation Claims necessary to make Along with the numerous aforementioned health benefits provided by omega-3 fatty acids, these nutrients have been claims generally and shown to possess anti-inflammatory properties, making them useful in the management of inflammatory and autoimmune structure/function diseases. Inflammation is the end result of oxidative stress that claims, in particular. can be caused by activities of daily living such as emotional or physical trauma, or nutritional and environmental exposure. Coronary heart disease, major depression, aging and cancer are all associated with chronic inflammation. Researchers have even recently found omega-3s may clear inflammation in Alzheimer’s disease, and they have also been shown to lower systemic inflammation to help slow and reverse the natural aging process. Arguably, inflammation is the human body’s protective mechanism to remove injurious stimuli, such as pathogens, damaged cells or irritants. In other words, it is not necessarily always related to disease. However, FDA tends to prohibit structure/function claims that so much as state the word “inflammation.”

Omega-3 Insights • Marketing Omega-3 Supplements 6 omega3insights.com It is, therefore, extremely difficult for companies to communicate the very real inflammation-reducing benefits of omega-3 dietary supplements without making what FDA would consider a disease claim. For example, a 2012 FDA warning letter found the following to be a disease claim: “Because the body cannot produce omega-3 that is commonly found in fish oil, it is important to take supplements like [product] to … limit inflammation that affects the brain.” There is no reason that this claim is being treated as an impermissible disease claim. Indeed, from a holistic vantage point, omega-3 fatty acids may help reduce inflammation, which has significant health benefits for our overall health in general and, in particular, to our brain, cardiovascular and eye health. From ophthalmologists to internists, more and more conventional physicians are recommending the use of omega-3 fatty acids for this purpose. Thus, from a regulatory perspective, we must move away from the antiquated approach of FDA (including its idea as to what is and is not a disease claim) to a more proactive approach that allows the free dissemination of the health benefits of not only omega-3 fatty acids but other dietary ingredients. It is extremely difficult for companies to Looking Forward The health benefits attributed to omega-3 fatty acids and communicate the very number of clinical studies only continue to grow, and high potency omega-3 dietary supplements are predicted to be real inflammation- increasingly popular the next few years. In 2004, high potency omega-3 products broke into the prescription drug market with reducing benefits of the approval of Lovaza®, a product containing approximately omega-3 dietary 465 mg of EPA and 375 mg of DHA. However, companies should note this does not mean that high potencies, similar to that of supplements without Lovaza, cannot be used in dietary supplements. It’s possible FDA will object to the use of high-potency making what FDA omega-3s in dietary supplements, considering it’s a new dietary would consider a ingredient (due to the 2004 Lovaza drug approval). However, the agency’s argument will likely fail. A new dietary ingredient is a disease claim. dietary ingredient that was not marketed in a dietary supplement in the United States before Oct. 15, 1994. Even if the ingredient was not marketed in a dietary supplement prior to Oct. 15, 1994, it does not fall under the new dietary ingredient requirements if it was marketed as food prior to that date. Omega-3 fatty acid ethyl esters (EE) have been marketed as dietary supplements since the 1970s, well before the 1994 cut-off. Moreover, high levels of omega-3s have been consumed as food for centuries.

Omega-3 Insights • Marketing Omega-3 Supplements 7 omega3insights.com Conclusion Unfortunately, the benefits of omega-3 fatty acids will continue to have skeptics, as the natural products industry as a whole continues to have its detractors. However, there is hard science behind the benefits of omega-3 fatty acids, and companies need to be able to communicate those benefits. Some of these benefits require FDA to abandon its antiquated notion as to what constitutes a disease claim, so companies are not fighting that issue. However, it also requires industry to cease making claims that are not properly substantiated if the level of omega-3 fatty acids in a particular product is not supported by the literature. This may mean companies making claims for mood or joint health cease making this claim for fairy-dust levels of omega-3s. It also means differentiating between the various different types of omega-3s. Are you making a cognitive health claim for a product that contains primarily EPA rather than DHA, for instance? In the end, omega-3s provide a world of opportunity, but the communication of its benefits must be carefully crafted to avoid the regulatory pitfalls that exist. q

Todd Harrison is the chair of Venable LLP’s food and drug group. He has been involved extensively on issues related to the marketing of foods and dietary supplements, including health claims, qualified health claims, structure/function claims, and nutrient content claims. He has developed strategies for companies to communicate information about their products without running afoul of FDA and FTC regulatory requirements.

Erin Seder is an associate in Venable’s regulatory practice group, where she advises clients on legislation and rulemaking proceedings that impact a broad range of industries. She also assists clients on a variety of ongoing regulatory compliance matters before FTC and other federal and state agencies and commissions.

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