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Public Submissions: Proposed Section 7 Declaration: That Products in Capsule, Tablet Or Pill Form Are Therapeutic Goods

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Public Submissions: Proposed Section 7 Declaration: That Products in Capsule, Tablet Or Pill Form Are Therapeutic Goods The Project Officer Section 7 Consultation 2009-11-30 Regulatory Compliance Unit Therapeutic Goods Administration PO Box 100 WODEN ACT AUSTRALIA Unilever Australasia manufactures food, home and personal care products and is a market leader across dozens of categories for foods, household and personal care products with brands such as Continental, Rexona, Sunsilk, Bertolli, Omo/Persil, Dove, Lipton, and Flora just to name a few. We are a member company of the Australian Food and Grocery Council (AFGC) and ACCORD, the peak national industry associations that represents the manufacturers and marketers of food and grocery products and formulated consumer, cosmetic, hygiene and specialty products, their raw material suppliers, and service providers, respectively. Our products are regulated across a range of different regulatory agencies and it is in our interests to have clearly defined interfaces between the separate regulators. For example: Foods and Therapeutics, Cosmetics and Therapeutics. As an active and involved member company of these organisations, we fully support the submissions of the relevant organisation, in this case, the AFGC as being representative of the industry response to this consultation. We note in the consultation paper both the TGA and FSANZ have raised concerns about food-medicines interface confusion being heightened by the practice of presenting certain foods in capsule, tablet or pill form. We disagree with the following assumption that this form of presentation, except in the case of unmedicated confectionery, gives the impression that the product is a medicine. Particularly at the current time where environment, sustainability and carbon footprint are impacting businesses from both a proactive business perspective, and also a growing regulatory imperative, compaction of product format provides a significant opportunity to respond to these issues. Examples of consumer products in categories that we participate in that have undergone compaction in recent times to the extent where they can be provided in a ‘tablet, capsule or pill’ form are: Dishwashing tablets; Laundry powders; Personal care products – skin care products in capsule format. We can also see future opportunities where there may be consideration of providing food in more compact formats for individual serves such as soup, beverage and/or stock tablets that require reconstitution prior to consumption, capsules with concentrated ingredients that require preparation/reconstitution prior to consumption. It would be inappropriate and unnecessary for these formats to be regulated as Therapeutic goods sole based on the product format as sold. Using these examples for potential future development, we are therefore opposed to the Proposed wording of the Section 7 Declaration as provided in this consultation to the effect: That goods when manufactured in a finished tablet, capsule or pill form, are for the purposes of the Act, therapeutic goods. Unmedicated confectionery in a finished tablet, capsule or pill form is excluded from the scope of this declaration. We believe this gives proposal provides competitive advantage to a particular sector of the food industry, and we therefore propose a more general exemption be developed for all tablet, capsule or pill format products that are presented for retail sale as a food, to the effect: That goods when manufactured in a finished tablet, capsule or pill form, are for the purposes of the Act, therapeutic goods. All finished tablet, capsule or pill form that are presented for consumption as a food are excluded from the scope of this declaration. As a current interface example of this we refer to the Therapeutic/Cosmetic interface where products presented for a cosmetic purpose are exempt from being regulated as therapeutic goods according to Therapeutic Goods (Excluded Goods) Order No 1 of 2008. We also refer to the relatively recent document released on the Food Regulation Secretariat website: Food-Medicine Interface The Processes Applied to Considering Products at the Food-medicine Interface in both Australia and New Zealand Prepared by the Food-Medicine Interface Working Group, Implementation Sub Committee of the Food Regulation Standing Committee July 2009. This document refers states the following: The process, and guidance tool, followed for Australia uses the definition of therapeutic goods (section 3 of the Therapeutic Goods Act, 1989) as a basis for the types of questions asked when considering the regulatory status of a product at the food-medicine interface. The questions in the guidance tool below are based upon how a product is presented and how it would be interpreted by consumers. 1. Is the product in an oral medicinal dosage form? 2. Does the product have medicinal dosage instructions (rather than a food serving suggestion)? 3. Does the product carry therapeutic claims (that is, claims relating to the therapeutic use)? 4. Does the product have a traditional or otherwise well-established therapeutic use in that form (that is, it is primarily for therapeutic use)? Although not directly relevant to this current consultation, we note that New Zealand also use a very similar set of four questions for products at the food-medicine interface. We therefore use these existing examples for providing regulatory clarity for products at regulatory interfaces as potential alternatives to be considered, as we directly oppose this proposal for products in tablet, capsule or pill format except for unmedicated confectionery to be regulated as therapeutic goods. Should you have any questions or require clarification on this submission, please do not hesitate in contacting me directly. I am also hoping by this submission to be included on the stakeholder list for consultation into the future. Yours sincerely Julie Newlands Regulatory Manager Unilever Australasia Contact details: Telephone: 02 9869 6221 .
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