The FDA Puts It in Writing
Editor’s Note: This article is intended for information purposes only. Because state and municipal laws vary greatly, as do the circumstances of individual cases, readers are advised to contact an attorney for specific legal advice. ©Scott Tips 2010
We have seen it so often these days that we have grown accustomed to it, lazy even, almost as if it’s normal. Energy drinks and nutraceutical drinks in supermarkets and gas stations that proclaim “dietary supplement” on their labels like some kind of cross held aloft by vampire hunters to scare away the night creatures. Meanwhile, the territory staked out by these “drinks” has kept expanding beyond the safely lit areas into the twilight and darker regions. A sense of safety grew with numbers even as the twilight darkened with every stride forward.
Then, of course, it happened. The night creatures struck. First, the U.S. Food and Drug Administration (FDA) threw Warning Letters at three companies marketing dietary-supplement drinks in sizes too large and with names too suggestive. A few days later, the FDA’s draft Guidance on this same issue was cast upon the world. Confusion now reigns as the magic words on the label seem to have lost their protective powers.
The Draft Guidance
So it was that, as an early Christmas present to the industry, the FDA created a draft guidance document with the catchy title, “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” (See www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm.) While not lengthy, it has enough statutory references to lull even the most resolute reader to sleep.
Yet, while we all know that these Guidance documents are neither fish nor fowl (i.e., neither law nor regulation), they do express the interpretation the FDA gives the laws and regulations that are intended to channel its actions. Such glimpses into FDA’s thinking are to be cherished by all who want to avoid the kind of regulatory action that has just struck the three industry members who opened their mailboxes only to find that the FDA was not wishing them a Merry Christmas.
What the Guidance says is that, first of all, supplement drinks that look like conventional beverages will be considered misbranded and removed from the market. Secondly, it says the use of any ingredients that are not approved food additives or GRAS for that intended use in conventional beverages will also make them subject to regulatory action. Lastly, it says that if a supplement drink is really nothing more than a conventional beverage, then it must be labeled as a conventional beverage and may not make inappropriate health claims.
So, the real key here is the meaning of the words “look like,” or, as the FDA quotes from section 201(ff)(2)(B) of the Dietary Supplement Health and Education Act (DSHEA), “the term ‘dietary supplement’ means a product that, among other requirements, ‘is not represented for use as a conventional food or as a sole item of a meal or the diet’” (emphasis added). This, then, is the launching point for determining all else. Is the supplement drink represented for use as a conventional food?
The FDA says that “beverages” are, in fact, conventional foods and that they will consider a supplement drink to be “represented for use as a conventional food” if: (1) It is packaged in bottles or cans similar to those in which beverages like soda, bottled water, fruit juices and iced tea are sold; (2) It suggests through the serving size, packaging or recommended daily intake that it is to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of a person (about 1.2 liters); or (3) It uses conventional food terms such as “beverage,” “drink,” “water” or “juice.”
Obviously fans of Kingsley Amis, who once wrote that “if you can’t annoy somebody, there’s little point in writing,” the FDA does more than just write boring interpretations of even more boring regulations. They also send snappy letters.
In quick succession, at the end of last November, the FDA spat out Warning Letters to three supplement drink manufacturers. These letters are actually important to more than just their recipients because they show the “bite” behind the FDA’s bark. They also illustrate a real-life application of that bite.
One of the lucky winners of the FDA’s “Annoy the Stakeholders” sweepstakes was the Skinny Nutritional Corporation in Pennsylvania, which was politely told that its “Skinny Water” beverage (marketed as a dietary supplement) is not really a dietary supplement but a conventional beverage. This, the FDA wrote, is because “the product is sold in a 16-ounce bottle (473 ml), and your website recommends a daily intake of 4 bottles a day, for a total fluid intake of 64 ounces per day (1892 ml).”
And just in case the company’s in-house mathematician was on vacation, the FDA obligingly added that, “Based on a data from the 2005-06 National Health and Nutrition Examination Survey on daily intake of drinking water and other beverages in the United States, FDA estimates the average total daily drinking fluid intake per person to be about 1.2 liter (1200 ml). The approximately 1.9 liter recommended daily intake of your product thus exceeds the total daily drinking fluid intake of an average person in the U.S.”
But the FDA subscribes to the belief that its victims must be thoroughly masticated, so it did not stop there. “In addition,” the FDA continued, “the product packaging, which is a bottle similar to the kind of bottle in which single servings of beverages like soda, bottled water, and iced tea are sold, suggests that Skinny Water is intended for use as a beverage. Beverages are conventional foods.” And, “the brand name ‘Skinny Water’ represents the products as conventional foods. Water is a beverage and, like other beverages, it is regulated as a conventional food.”
The other two Warning Letters were of similar wording and import. But just because the Night Creatures say it is so does not make it so. That is what the courts are for in these kinds of cases—to interpret the law and to restrain abuses of power, among other things.
“Represented as” is a funny phrase, susceptible to many meanings. The English writer Chesterton pointed out a similar quality in the word “good.” “For example,” he wrote once, “if a man were to shoot his grandmother at a range of 500 yards, I should call him a good shot, but not necessarily a good man.” So which meaning does “represented as” really have here?
Actually, DSHEA does not say anywhere within it that a dietary supplement cannot look like a conventional food, be eaten or drunk in large amounts, or use specific words such as “drink.” This is just the FDA’s interpretation of DSHEA on this point. It’s not necessarily wrong or right per se, it’s just one party’s interpretation.
Unfortunately, courts give the FDA’s interpretations of rules and regulations far more weight than they deserve. Given that the FDA is not competent enough to regulate even itself, let alone a country’s food supply, and given that its offices are stuffed chockfull of bureaucrats whose minds are not thinking of more freedom but of less freedom, the judicial preference for FDA’s opinion is incredibly misplaced. Yes, we all know that the FDA is supposed to be representing the public interest and not some “dirty” commercial interest; but if there is anybody out there who still believes that fairy tale to be true after decades of drug-industry-FDA incest, then they probably also believe that the radio works because there are tiny people inside of it.
To my mind, “represented as” simply means what it says: it is a deliberate claim made by the manufacturer or distributor. It is not a function of the size of the beverage container, since that is not a claim, and it is not a function of the quantity to be drunk, since, for example, a highly-diluted supplement ingredient may need more liquid intake than a highly-concentrated one. On the other hand, representing a supplement as “drinking water” could be reasonably construed as crossing the regulatory threshold from supplements to foods.
But the bottom line really is that the Food, Drug, and Cosmetic Act was ostensibly passed to protect the public. If these supplement ingredients are already safe—and please keep in mind that supplements have a decades-long track record of safety that far and away outstrips that of FDA-approved drugs, licensed medical doctors, and even inspected foods—then why not allow these ingredients to be used in conventional foods as well? It is like the silliness of the ephedra ban, where ephedra above a certain amount was banned in dietary supplements found in Aisle 8 but perfectly okay to buy in an herbal teabag or OTC cold remedy found in Aisles 3 and 17. It is a glorification of form over function. Maybe instead it would be wiser to change the onerous food-additive regulations to make an exception for supplement ingredients. After all, the public’s health would be improved by more nutritious foods, whether the magic words “dietary supplement” appear on the label or not. WF
A graduate of the University of California at Berkeley Law School, Scott C. Tips currently practices internationally, emphasizing Food-and-Drug law, business law and business litigation, trade practice, and international corporate formation and management. He has been involved in the nutrition field for more than three decades and may be reached at (415) 244-1813 or by e-mail at email@example.com.
Published in WholeFoods Magazine, Feb. 2010