(This blog post was originally published Jan. 15, 2014, on Food Politics.) By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods – energy shots, for example. Under the law, FDA pretty much has to keep its hands off of supplements, except when something egregious happens, like people getting sick or dying. FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs. The agency just issued:

These documents, however, are guidance. They are not regulations:

“This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.”

Why is FDA doing this? I’m guessing for two reasons. 1.  The weird ingredients in energy drinks:

“We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses. Some of these products are marketed as dietary supplements, and others as conventional foods. “We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts. Some of these substances have not previously been used in conventional foods and may be unapproved food additives.”

2.  The high caffeine levels in those drinks:

“Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods. This trend raises questions regarding whether these new uses are unapproved food additive uses.”

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks. But the levels in energy drinks are so much higher that FDA has questions about whether GRAS applies to them. These guidance documents are open for comment.  If you care about such issues, weigh in now.

  • Marc Ullman

    Actually, dietary supplements are more heavily regulated than food.

    Dietary supplements are subject to much more rigorous Good Manufacturing Practices than food.
    Suppliers of dietary ingredients are required to provide FDA with safety data prior to offering the ingredient for sale in the United States; suppliers of food ingredients are not required to provide FDA with any information relating to their GRAS determinations.

    Dietary supplement companies are required to notify FDA of Serious Adverse Events reported in connection with their products; food companies are not.

    The reason many “energy drinks” were introduced to the market as supplements was because there was insufficient published data to allow for a GRAS determination for many of the herbal ingredients these companies use. With the passage of time, that is no longer the case and most of these products are now marketed as foods so that these companies can avoid Adverse Event Reporting and have their products produced in accordance with food (rather than supplement) GMPs.

    • Emily73

      You are completely wrong. Dietary supplements are not much more heavily regulated than food. Manufacturers don’t even have to make sure that the pills they offer for sale have the ingredients they claim. The Dietary Supplement Health and Education Act of 1994, which is comically mis-named, was bought and paid for by the supplement industry and basically got the government out of the business of monitoring supplements. “DSHEA also removed much of the FDA’s control over dietary supplements and created what is considered by many health officials to be a virtually unregulated industry.” Do some research before you say something you know nothing about. http://iml.jou.ufl.edu/projects/spring2000/kimpel/history.html

      • Actually Emily, I suggest that you read 21 CFR Part 111 before you suggest that anyone knows less about supplement regulation than you.