Wednesday 26 July 2017

FDA Issues Two New Guidance Documents; Energy Drinks and Liquid Dietary Supplements Under New Scrutiny

The US FDA issued two new guidance documents focused on energy drinks following a Congressional call for action.  The final Guidance for Industry entitled, “Distinguishing Liquid Dietary Supplements from Beverages” follows the previously issued Draft Guidance for Industry entitled, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” in December 2009 and the FDA had indicated recently on numerous occasions that a revised guidance would be forthcoming. Simultaneous with the issuance of this guidance, the FDA issued another Guidance for Industry entitled, “Considerations Regarding Substances Added to Foods, including Beverages and Dietary Supplements.” That guidance contains some of the language that was in the previous version of the guidance entitled, “Distinguishing Liquid Dietary Supplements from Beverages” and addresses some of the FDA’s concerns over the use of novel substances in beverages and conventional foods.

The two new guidance documents will add new scrutiny to an industry already renowned for FDA violations and adverse events. Expect the guidance documents to be cited in upcoming warning letters, import alerts and Form 483. 

Below is a summary of the new guidelines.

Distinguishing Liquid Dietary Supplements from Beverages

The FDA identifies a number of factors that it may consider in determining whether a product is represented as a conventional food and therefore, prohibited from being marketed as a dietary supplement. Although, there are some circumstances in which a single factor may be enough for the FDA to deem a product to be represented as a conventional food, in most cases, the FDA will review a combination of factors and the overall context to make a determination.

Some of those factors that the FDA may review include the following:

  • Product Name. Product or brand names that use conventional food terms such as “beverage,” “drink,” “water” or “soda” are viewed by the FDA as representations of the product as a conventional food or beverage. In some instances, the FDA asserts that use of one of the terms alone may be sufficient to establish a product as a conventional food. In other instances, use of the term will be viewed in context with other factors.
  • Labeling and Advertising. The FDA may consider statements and graphics on labels, labeling and advertising, including websites and social media, like Facebook or Twitter. The use of words like “refresh” or “rehydrate,” which the FDA asserts represents the product for use as a beverage, may cause the FDA to deem a product labeled as a dietary supplement to be a beverage, as well as graphics depicting a use associated with a conventional food.
  • Recommendations and Directions for Use. Recommendations or directions to use a dietary supplement product like a beverage, such as for quenching thirst, may represent the product as a conventional food. Conversely, directions to use a liquid product as to supplement the diet in a manner similar to other dietary supplements may be a factor in favor of a determination that the product is not being represented as a conventional food.
  • Marketing Practices. This factor was not present in the previous version of the guidance. Marketing practices identified by the FDA that may represent a product as a conventional food include comparing the product to a category of beverages (e.g., energy drinks), using metatags such as “beverage” or “drink,” and paying for a product to be displayed in the beverage section of retail stores.
  • Other Representations. Other representations which might cause the FDA to determine that a product is represented as a conventional food include statements made in public filings with government agencies like the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.

The classification of a product as a dietary supplement or a conventional beverage matters. One area of focus is on ingredients. Conventional foods and dietary supplements follow different GRAS criteria and dietary ingredients may be subject to contraindications or restrictions on serving size. Dietary ingredients may also not be approved for food at all and require a New Dietary Ingredient (NDI) application. The Guidance Document makes this clear:

Many substances intentionally added to beverages are food additives, which require premarket approval by FDA. (See section 409 of the FD&C Act [21 U.S.C. 348] and 21 CFR Part 171.)  A substance is exempt from the definition of a food additive, and thus from pre-market approval, if it is generally recognized as safe by qualified experts under the conditions of its intended use in food (see 21 CFR 170.30), or if it falls under another exception to the food additive definition in section 201(s) of the FD&C Act (21 U.S.C. 321(s)).

Substances that are “dietary ingredients” under section 201(ff)(1) of the FD&C Act (21 U.S.C. 321(ff)(1)) must not adulterate the dietary supplement to which they are added (see section 402 of the FD&C Act [21 U.S.C. 342]).  In addition, dietary ingredients that were not marketed in the United States before October 15, 1994, are “new dietary ingredients” subject to the requirements of section 413 of the FD&C Act (21 U.S.C. 350b) and 21 CFR 190.6.

Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) exempts dietary ingredients used in dietary supplements from the food additive definition.  Although a dietary ingredient used in a dietary supplement must not adulterate the supplement under section 402(f) of the FD&C Act (21 U.S.C. 342(f)), it does not have to be GRAS for its intended use in the supplement.  However, other ingredients intended for use in dietary supplements, such as binders, excipients, and fillers, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods.  In other words, non-dietary ingredients added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for their intended use (unless they qualify for another exception to the food additive definition). See the discussion in section III.D.1 of this guidance and References 3 and 4.

This is in addition to the difference in labeling claims allowed for conventional foods and dietary supplements. The second guidance document largely follows-up on this distnction and emphasizes the point.

The first purpose of the guidance is to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages.  “Substance” is defined in FDA’s food additive regulations to include foods and food components consisting of one or more ingredients (21 CFR 170.3(g)).  Thus, a “substance” for purposes of the regulations and this guidance may be a food (e.g., an apple) that can be eaten on its own as well as used as an ingredient in other foods, or it may be a food that is used only as a component of other foods (e.g., flour).  A second purpose of the guidance is to remind dietary supplement manufacturers and distributors that the same requirements apply to certain substances that are added to dietary supplements — namely, those that are not dietary ingredients as defined in section 201(ff)(1) of the FD&C Act (21 U.S.C. § 321(ff)(1)).

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