Faster, Stronger, Smarter: Considering the Dietary Supplement Regulatory and Litigation Landscape

Abstract

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 sleep! 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 selfreport 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 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 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 supplement community, but it does not address the science of supplements.I. DSHEADietary 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 categoiy 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 ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a substance for use by man to supplement the diet by increasing the total 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 supplement.2DSHEA 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 supplements. The law does require the company to alert the FDA if they receive reports of serious adverse events associated with the use of supplements.3After 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 ingredient. New ingredients include any ingredient that was not sold in the U.S. as a supplement before October 15, 1994. …