DIETARY supplements are something of a world apart. They are able to tout amazing health and fitness benefits--Get lean and ripped faster! Lose weight while you sleep1. Improve overall brain function!--at times seeming to border on miraculous claims. But not quite. Failing to make actual health claims relieves them, generally, from the pre-release testing and requirements of drugs. Manufacturers do not have to submit their proposed product to the FDA for testing and approval prior to release as long as the ingredients fall into fairly broad categories. Dietary supplement manufacturers and distributors are put in the same regulatory category as other food products, which means that they must self-report to the FDA and comply with the FDA's Good Manufacturing Practices. It is up to the FDA, once it has received notice of a danger, to prove that a supplement is unsafe or a claim is false or misleading.
Because of this almost "after-the-fact" process, the FDA may investigate claims of adulteration or danger, or false labeling/ false claims at the same time a company is defending against a civil lawsuit. The civil lawsuit may be the true test of the dietary supplement company's mettle. This article considers the underlying regulatory framework, how to defend a product liability claim, and the rise of false claims suits. This article provides greater detail of the legal landscape for litigators and members of the dietary supplement community, but it does not address the science of dietary supplements.
Dietary supplements are governed by the regulations under the Dietary Supplement Health and Education Act of 1994 (the "DSHEA"). (1) This act is under the purview of the Food and Drug Administration, and is a part of the larger Federal Food, Drug and Cosmetic Act ("FFDCA"). Dietary supplements are included as a special category of "foods," not drugs.
DSHEA covers any "dietary supplement", defined as:
(1) a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A)-(E).
(2) ... a product that (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement. (2)
DSHEA created a slightly unorthodox framework of regulation, imposing the responsibility on the manufacturer or distributor to make sure its products are safe. The manufacturer or distributor is also responsible for assuring that any representations or claims made about its products are substantiated by adequate evidence to show that they are not false or misleading. Neither manufacturers nor distributors have to provide the FDA with the evidence on which they rely to substantiate safety or effectiveness before or after they market products.
In essence, DSHEA sets matters up in the opposite way of traditional drugs: with drug products, the manufacturer has to prove to the FDA that the drug is safe and effective for its intended use before marketing. There are no such requirements for dietary supplements. The law does require the company to alert the FDA if they receive reports of serious adverse events associated with the use of dietary supplements. (3)
After supplements go to market, the FDA must prove that the product is "unsafe" before it can take any action to restrict the product's use or remove it from the marketplace. (4) The only time a manufacturer will have to seek approval from the FDA in advance is when the supplement contains a "new dietary ingredient." New dietary ingredients include any dietary ingredient that was not sold in the U.S. as a dietary supplement before October 15, 1994. (5)
Dietary supplement manufacturers must also register with the FDA pursuant to the Bioterrorism Act (6) before producing or selling supplements. The FDA has published regulations for current Good Manufacturing Practices ("cGMP") for those who manufacture, package or hold dietary supplement products. The focus of these regulations is ensuring the identity, purity, quality, strength and composition of dietary supplements. (7) The cGMP cover everything from facility sanitation to proper implementation of a system of production and process controls and quality control. With respect to quality control, a manufacturer should be sure to have written plans--and recorded implementation--of laboratory operations and production operations to ensure quality and that the supplement is packaged and labeled as intended. (8)
The cGMP regulations should be taken seriously; the FDA has the authority to conduct inspections and, through the Department of Justice, to shut down operations. In the summer of 2012 the FDA and the Department of Justice sought an injunction to shut down the operations of a dietary supplements manufacturer in New York. (9) The Complaint outlined a history of inspections and warning letters that resulted in the FDA finding that the company ignored cGMP. In April of this year, the government and the manufacturer entered into an onerous consent decree. Per the decree, the manufacturer agreed, inter alia, to (1) hire an independent expert to inspect and certify that its facility met cGMP; (2) ensure the FDA approved that expert certification prior to restarting business; (3) submit to twice-yearly audit inspections by an expert, and unannounced inspections by the FDA; (4) reimburse the FDA for all expenses associated with the reviews and inspections going forward; and (5) agreed to penalties of $15,000 per violation per day for any future violations. (10) This should serve as a warning to companies to be sure they understand what is required by the cGMP and handle any inspections and subsequent warnings from the FDA carefully.
Labeling Under DSHEA
The basic labeling requirement under DSHEA is obvious. All dietary supplements must be labeled "DIETARY SUPPLEMENTS." (11) Certain types of claims are specifically authorized. Authorized statements are allowed that describe "the role of a nutrient or dietary ingredient intended to affect the structure or function in humans" or that "characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function." Like the substances themselves, claims and labels do not have to be preapproved by the FDA. The company only has to provide notice to the FDA within 30 days of first use of any claim and must include a disclaimer on the label stating that the FDA has not evaluated the claim and that the product is not intended to "diagnose, treat, cure or prevent any disease." (12)
The FDA does have a record of tracking down companies that exceed appropriate labeling. The FDA recently issued warning letters to dietary supplement firms for promoting their supplements as drugs. (13) Under DSHEA and the FFDCA, a dietary supplement cannot claim to cure, treat or prevent disease. The products at issue, even though labeled dietary supplements, billed themselves as being able to treat concussions and prevent post-concussion syndrome and related neurological disorders. The FDA issued the warning letters because these claims were not FDA approved and the products had not been adequately tested for substantiation of the claims.
The FDA is not the only litigant over manufacturers' labeling claims. Private litigants will also take companies to task In Stanley v. Bayer Healthcare LLC, the court addressed a claim of inappropriate labeling, finding for the manufacturer because the labeling at issue reflected the general endorsements that labels for dietary supplements can make; it was plaintiff s interpretation of it that went beyond what was reasonable. (14)
The importance of proper labeling underscores the intent behind the labeling requirements, making sure supplements are safe to market. Everyone in the chain of dietary supplement distribution--designer, manufacturer, distributor, and retailer--should make efforts to make sure the product is actually safe. The current regulatory regime allows companies to police themselves to a great extent regarding safety. This regime has arisen because of how DSHEA was written: the act obviates the need for FDA control so long as the supplement contains only dietary ingredients marketed before October 15, 1994. (15) Essentially, it...