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FDA is concerned that some companies are selling what are essentially conventional beverages as dietary supplements.
Liquid dietary supplements should not be sold as conventional drinks, and FDA draft guidance released yesterday explains why. The agency published the final draft of “Distinguishing Liquid Dietary Supplements from Beverages,” advising companies what conditions would classify a dietary supplement as a beverage, and vice versa.
FDA is concerned that some companies are selling what are essentially conventional beverages (drink-sized servings, “thirst-quenching” marketing statements, etc.) as dietary supplements in order to skirt food additive or Generally Recognized as Safe (GRAS) regulations governing ingredients used in conventional foods. Dietary supplement ingredients must meet their appropriate Dietary Supplement Health and Education Act of 1994 regulations under the Food, Drug & Cosmetic Act, including New Dietary Ingredient regulations, but they are not subject to premarket-approval, food-additive regulations nor GRAS rules. FDA says a dietary supplement is misbranded if marketing and other factors make it a conventional beverage instead.
Not all ingredients authorized in dietary supplements are allowed in conventional foods. To further remind the public about which rules govern dietary supplements versus conventional foods, FDA also released additional guidance, titled “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.”
The draft guidance addresses topics such as labeling and advertising, product name, packaging, serving size, directions for use, and ingredient composition. Some notable takeaways:
Powdered premixes and “add to water” liquid concentrates are also addressed. FDA says that if powdered premixes and liquid concentrates are labeled as dietary supplements, and not conveyed as beverages in any way, consumers are unlikely to confuse them with conventional foods.
Read about how FDA arrived at this final draft guidance in past Nutritional Outlook coverage on this topic: