Ever since Nutrafol announced its first-ever multiyear partnership with Major League Baseball, consumers have asked whether the product is “FDA approved.” Nutrafol is a brand of hair-growth supplements containing a blend of vitamins, minerals, and botanical ingredients intended to address factors such as stress, hormonal imbalances, and inflammation that contribute to hair thinning. It is available in different formulations for men and women and is designed to improve hair thickness, strength, and growth while reducing shedding. However, despite the question appearing straightforward, determining whether this product is “FDA approved” requires a deeper look into FDA law and regulation – starting with exploring how FDA regulates Dietary Supplements.
The history of FDA regulation of Dietary Supplements has been marked by alternating periods of heightened enforcement and relaxed oversight. Many observers were, in fact, surprised in 1994 when Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”), which adopted a more permissive regulatory approach following years of distrust between industry and the FDA. DSHEA defines “dietary supplements” as:
a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients… a vitamin; a mineral; an herb or other botanical … a dietary substance for use by man to supplement the diet by increasing the total dietary intake… means a product that— is intended for ingestion… is not represented for use as a conventional food or as a sole item of a meal or the diet; and… is labeled as a dietary supplement….
The DSHEA then carves “Drugs” out of the definition of Dietary Supplements:
[does not include] an article that is approved as a new drug… or licensed as a biologic… or an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public….
In other words, dietary supplements are defined as products—though not drugs—intended for ingestion, not represented as conventional foods or meal replacements, and labeled as dietary supplements.
The DSHEA, in 21 U.S.C. § 343(r)(6), also created new categories of claims applicable to dietary supplements, referred to as “statements of nutritional support”:
Statements describing benefits related to classical nutrient deficiency diseases;
Statements describing the role of a nutrient intended to affect the structure or function of the human body;
Statements characterizing how nutrients act to maintain normal structure or function; and
Statements describing general well-being from consumption of such nutrients.
As clarified by FDA, “nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread such a disease is in the United States.” Structure/function claims “may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body…” Finally, general well-being claims “describe general well-being from consumption of a nutrient or dietary ingredient.”
It is important to note that none of these claim types are subject to pre-approval by FDA (this is also the case with most promotional claims made about drugs after approval). However, manufacturers must substantiate all claims, and such claims must be truthful and not misleading. Firms must also submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement bearing the claim. Dietary supplement claims must also carry a disclaimer stating that the claims have not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.
Notably absent from DSHEA is any requirement that FDA approve these products before they are marketed (unless the product contains a New Dietary Ingredient (“NDI”) which requires submission of a notification to FDA including the information on which the firm has concluded that the NDI-containing supplement is reasonably expected to be safe).
This, of course, stands in contrast to new drugs. The Food, Drug, and Cosmetic Act, on the other hand, defines Drugs as:
articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals… articles (other than food) intended to affect the structure or any function of the body of man or other animals…
21 CFR 201.128 defines “Intended Use” refers to:
the objective intent of the persons legally responsible for the labeling of an article… shown by such persons’ expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives…
Unlike Dietary Supplements, manufacturers of Drugs do require premarket approval. For new Drugs, the basic pathway for getting a product approved is via the New Drug Application (“NDA”) which is intended to determine the safety and effectiveness of a drugs proposed use, the appropriateness of the proposed labeling and the adequacy of manufacturing methods to assure the drugs identity, strength, quality, and purity. The NDA process is long and can be extraordinarily expensive and only after shouldering this significant burden can a product be “Approved” by the FDA.
Taking FDA’s statutory and regulatory scheme into consideration, we can see that Nutrafol is a Dietary Supplement, and not a Drug. Therefore, as a Dietary Supplement (unless the product contains an NDI), Nutrafol does not require, nor does FDA have the authority to provide, “Approval.”