The Relationship Between the FDA and the Supplement Industry

In 1993, the New York Times reported that the Food and Drug Administration proposed regulations be set forth to guide or control the vitamin and supplement industry. At that time, the market for supplements accounted for about four billion dollars in revenue a year. The ongoing issue the FDA has with the supplement industry is twofold; one is the regulation of health claims made by supplement companies, and two is a regular, systematic review of supplements for the presence of unclaimed or illegal ingredients.

Jump forward to 2018, and CNN reports that between the years of 2007 and 2016, 800 supplements analyzed by the FDA contained unapproved ingredients. In 20 percent of those supplements, more than one unapproved ingredient was found, according to the Journal of the American Medical Association investigation. Yet, despite this long ebb-and-flow relationship, the FDA has yet to establish regulations for over-the-counter supplements. Unlike prescription medications, supplements do not need to be approved by the FDA before being sold. The supplement company must inform the FDA of the supplements release. The only approval required from the FDA is for the label.

What would make the FDA happy?

It appears supplement companies have only two steadfast rules to stay in the good favor of the FDA. Rule No. 1: Do not make medical claims for products that have not been approved by the FDA for medical conditions. Rule No. 2 is to include only natural, herbal ingredients in supplements to be sold over-the-counter. Do not add unapproved or prescription medications to the formulas.

So what does this mean for the seller?

Sorting through the terminology used by the FDA can be overwhelming. But there are some keywords to consider in labeling and description.

Treat. Claiming a supplement will treat a medical condition, such as high blood pressure, diabetes, or cancer, is illegal. Over-the-counter supplements are not approved as treatments, only as a support system, if you will.

Clinically proven. The phrase clinically proven is a bit of a gray area when it comes to dietary supplements. Because clinical trials are amazingly expensive, very few supplement companies have the capital to formally test their supplements. So, saying your brand’s supplement is clinically proven is not true. More than likely, the ingredients used in the formula have either been clinically tested or clinically proven to aid general health in some way.

May versus will. When you understand the relationship between the FDA and the industry, you will often use the word may instead of will. For instance, “this herbal pill may help ease anxiety” versus “this herbal pill will ease anxiety.” The latter of the two is considered a medical statement of treatment by the FDA. Unless a company has completed human trials and applied for approval from FDA, medical statements of treatment are illegal.

What part do the dietary supplement manufacturers play in this back-and-forth game with the FDA?

Few, if any, supplement companies formulate, package, bottle, and label their products. This is where dietary supplement manufacturers come into the picture. The goal the manufacturer has is simple: Be the best in the business. The manufacturer must work in an FDA-registered facility and hold a current GMP manufacturing certification. The manufacturer must have liability insurance capable of covering legal costs for them and you.

But the most essential characteristics of the best supplement manufacturer are transparency and knowledge. Avoiding questions, giving vague answers, or refusing access to the manufacturing facility or details of the manufacturing process could mean you’re on the path to an FDA red flag.