How can companies adhere to FDA and FTC guidelines and still communicate vital information about nutrition and dietary supplements to consumers? Many industry and legal experts have been engaged in discussions related to this topic. So let’s explore some examples of FDA and FTC guidance and recent legal decisions to open this issue for greater debate. It should be noted that since the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 the Supreme Court said in a ruling that FDA was being too paternalistic in enforcement of the law. The question remains: where is the line between sharing information and outright advertising? There seems to be a gray area.

To start this conversation, I think it best to review the concept of free speech. The First Amendment to the U.S. Constitution reads in part: “Congress shall make no law … abridging the freedom of speech.”

According to Michigan State University (MSU), “The Courts have interpreted the language to mean that no arm of the government, federal or state, can abridge the free speech right.” At the heart of free speech is freedom of expression. In the DSHEA context, this freedom of expression may include the right to state an individual’s belief, or to convey a certain view. However, there are exceptions. According to MSU, most exceptions relate to health and safety concerns. This is where the slope gets slippery. It is also important that there is an exception for false advertising. You cannot advertise falsely and claim freedom of speech or expression.

In 2010, a bill was introduced (and later died) in Congress to further allow the dissemination of scientific information by dietary supplement companies to consumers—information that was from published, peer-reviewed studies, such as those found on www.pubmed.gov. More specifically, the legislation (H.R. 4913 Free Speech About Science Act of 2010) sought to amend Section 403(r) of the Federal Food, Drug, and Cosmetic Act by allowing dietary supplement and health food makers to reference research from a peer-reviewed article, book or scientific publication; a recognized textbook; or a publication from the U.S. government. The bill also suggested that referencing scientific literature would not convert such products into an unapproved, illegal new drug.

Healthy vs. Disease Populations
One may ask why dietary supplement companies cannot use peer-reviewed, published science or other published materials in marketing products to consumers; and the answer is perhaps murky. Dietary supplement companies can, in fact, use published studies to engage the consumer; however, those studies have to involve relatively healthy populations, and not people suffering from disease or medical conditions.

Under the law, dietary supplements are not permitted to diagnose, treat, cure or prevent any disease or condition. In other words, FDA will allow you to discuss studies published in the public domain that may use your product, or an ingredient in your product, as long as the study was not conducted on anyone with a disease or medical condition. Only prescription or over-the-counter medicines can utilize studies involving disease populations to support product marketing.

‘Misbranding’ (Off-Label Marketing)
Further complicating freedom of speech/expression, pharmaceutical companies are allowed to discuss studies on ingredients (drugs) with doctors and the public, including studies on indications beyond which FDA approved for the medicine.

For example, company “X” can discuss how in a published study its medicine worked for cancer, while it is only approved for use in blood sugar regulation for Type 2 diabetics—crazy, but true. Recent court rulings against FDA have forced the agency to rethink the words it uses when charging an individual or company with illegal marketing activities. The word du jour is “misbranding,” as opposed to off-label marketing.

Another instance of “misbranding” relates to marketing a drug for indications not yet approved by FDA. In a recent New York case, a federal appeals court overturned the conviction of a drug sales representative named Alfred Caronia who was selling Xyrem, a drug approved for narcolepsy, to doctors as a treatment for insomnia, fibromyalgia and other conditions. The three-judge panel of the Court of Appeals for the Second Circuit in Manhattan ruled that FDA violated Mr. Caronia’s “freedom of speech” and was in the wrong.

This ruling made me wonder if any dietary supplement company would be willing to take on FDA in order to broaden the ability to communicate with the public about the potential uses of nutrition and dietary supplements beyond healthy populations. Now, it should be noted that the ruling in the United States vs. Caronia case was based on an earlier Supreme Court case known as Sorrell vs. IMS Health. Supreme Court cases affect rulings throughout the U.S. whereas appellate court cases typically apply to a smaller district.

Antioxidant Case Study
Bear with me for a moment while I review the definition of “antioxidants.” In a guidance document, FDA described what it considers an antioxidant: “Can I make an antioxidant nutrient content claim for any ingredient in a food? No. An antioxidant nutrient content claim can only be made for nutrients for which there is an RDI established in 21 CFR 101.9 (21 CFR 101.54(g)(l)).”

In plain English, it would be incorrect to state on packaging or consumer messaging that a product containing polyphenols is an “antioxidant” because polyphenols are not recognized as vitamins or minerals with a known RDI. However, this too gets a little muddled when considering that the phrase “antioxidant activity” is within the FDA Guidance documents. More specifically, “…nutrients that have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions” can be called antioxidants.

So, this is where the use of peer-reviewed, published research and/or original research has great value. If you demonstrate that a phytochemical within your nutritional agent (dietary supplement) or food has antioxidant activity (in humans and not in vitro), and further, the data is published in a peer-reviewed scientific journal, then you have a case to utilize the antioxidant term in your messaging. Again, this exemplifies how science has merit for the consumer.

This is an interesting time for the dietary supplement industry. It is abundantly clear that more finished-product, human clinical trials are needed in order to move science forward and to help promote health further. Greater clarity is also needed for how published science can be shared and communicated to the public. Thus, it is important to follow cases related to the pharmaceutical industry and FDA, as there are always implications when legal decisions, precedent or not, are made.    

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Douglas Kalman, PhD, MS, RD, FACN, is director of clinical nutrition at Miami Research Associates (MRA), Miami, FL, in the Nutrition and Endocrinology Division. MRA is a clinical service organization involved for over 10 years in phase II through post market trials for the pharmaceutical and nutraceutical industries. Mr. Kalman is also an active member of the American College of Sports Medicine, American College of Nutrition, the American Dietetic Association, the National Strength and Conditioning Association and the Association of Clinical Research Professionals. He is also the executive vice president and treasurer of the International Society of Sports Nutrition (ISSN). He can be reached at 305-666-2368; Fax: 305-669-8966; E-mail: dkalman@miamiresearch.com; Website: www.miamiresearch.com.