Beverage or Dietary Supplement? FDA Issues Final Draft Guidance

Liquid dietary supplements should not be sold as conventional drinks, and FDA draft guidance released yesterday explains why.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The draft guidance addresses topics such as labeling and advertising, product name, packaging, serving size, directions for use, and ingredient composition.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:

• Words like refresh or rehydrate, as well as drink, water, or soda, used in labeling or advertising indicate a conventional beverage-even if the product’s label bears a Supplement Facts Panel versus a Nutrition Facts Panel. “Drinking” symbols or graphics also classify a product as a beverage.

• These rules also govern social media marketing, as well as Internet and retail marketing-specifically, “the use of metatags^[2] that result in the product’s appearing in the results of an electronic search for sodas, juices, or other beverages; and paying for the product to be displayed in the beverage section of retail stores.”

• If a product’s directions for use are more inline with supplements (e.g., take one tablespoon three times per day), that may classify the product instead as a dietary supplement.

• Recommending that a product be taken with a meal does not necessarily make it a conventional food. Marketers can still recommend that a liquid dietary supplement, like many supplements, be taken with a meal. Basically, liquid dietary supplements are not intended to serve as source of fluids like a beverage does. For supplements, a “labeling or advertising statement promoting a liquid vitamin C supplement as a quick and easy alternative to drinking orange juice would not represent the product as a conventional food because it would be promoting the supplement as a more convenient source of vitamin C, not as a beverage to quench thirst, provide fluids, or wash down a meal.”

• If the bulk of a product’s ingredients are conventional food ingredients, simply adding one dietary supplement ingredient may not necessarily alter the product into a dietary supplement. “The product is essentially a copy of a common beverage with a dietary ingredient added,” the guidance states. “For example, adding a botanical such as ginkgo to kool-aid or non-alcoholic eggnog would not automatically create a product that could be marketed as a ‘ginkgo supplement.’”

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:

http://www.nutritionaloutlook.com/article/drawing-line

http://www.nutritionaloutlook.com/news/fda-publishes-new-draft-guidance-liquid-beverages-supplements