Natural and Dietary Supplements
In the United States, the FDA regulates both final products and ingredients in food additives, pursuant to the Dietary Supplement Health and Education Act (DSHEA) of 1994. For supplements that do not have any novel dietary ingredients, which are those dietary ingredients not sold to the public prior to Oct. 15, 1994, manufacturers are not required to submit proof of the products safety to FDA, before or after marketing. Although the DSHEE does require manufacturers to label their products as supplements and to provide a complete list of ingredients, manufacturers are not required to notify the FDA about adverse event reports that they might have received from consumers. Identifying food additives for Food and Drug Administration (FDA) recalls can occur through a number of mechanisms, including random sampling from manufacturers, recommendations for potentially adulterated products by retailers, adverse event reports by consumers and physicians, and many others.
Because the dietary supplement industry takes consumer safety seriously, we called for Congress to pass new consumer reporting requirements for severe adverse events in 2006, and we supported Congress adding registration of businesses to the FDA, as well as drug enforcement authorities, in 2011, to ensure that recalls for adulterated products are carried out. Unfortunately, a 1994 law known as the Dietary Supplement Health and Education Act [DSHEA] made it very difficult for FDA to act on, and provided very little protection from, unsafe products.
The act attempted to strike a fair balance between providing consumers access to the dietary supplements that they may wish to use to maintain and improve their health, and at the same time giving FDA regulatory authority to take action against supplements or food ingredients products that present safety problems, make false or misleading claims, or are otherwise adulterated or misbranded. The law also prohibits manufacturers and distributors of dietary supplements from marketing dietary ingredients in products manufactured in contaminated environments or containing harmful ingredients, as well as those with misleading labels or unsubstantiated claims. Under the existing law, FDA may act only when it finds dietary supplement manufacturers made unlawful claims about their products or were in violation of the products labeling regulations.
While FDA has requirements for labeling and product safety, it relies more heavily on monitoring supplements post-market, except when products have non-GrA (generally recognized as safe) or novel ingredients. The Act subjects supplements to more stringent manufacturing regulations, and requires the FDA to notify of new ingredients. This proposal would require supplements manufacturers to submit to FDA background information on products they sell, including what ingredients are in these products, as well as a copy of the label.
Under the Dietary Supplement Health and Education Act (DSHEA)–the 1994 act that established the current regulatory framework for dietary supplements–the FDA does not typically do a premarket review of dietary supplements, and manufacturers are not required to provide the agency with basic information about their products, including names or ingredients, prior to selling them.20 This leaves the agency without a clear picture of what is on the market at any given moment. Although supplement products cannot be sold as treatments for or preventions of diseases claims may describe only how a specific nutrient or food ingredient affects body structure or functions–manufacturers are not required to provide evidence to the agency proving claims made for their products.15 Even when they are required to do so, the evidence supporting dietary supplements. The 1994 Dietary Supplement Health and Education Act, DSHEA, amended federal food regulations to establish a separate regulatory framework for dietary supplements, seeking to strike a fair balance between providing consumers with access to dietary supplements that they may choose to use to maintain and enhance health, and giving FDA the regulatory power to act on supplements that pose safety problems, have false or misleading claims, or are otherwise adulterated or misbranded.
The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have jointly issued warning letters to seven manufacturers of dietary supplements that sold products that made claims about diseases, affirming that dietary supplements cannot make claims about preventing or treating diseases. Because products were being advertised on company websites and on social media under the pretext of protecting, killing, or fighting coronavirus, or preventing COVID-19, FDA and the FTC determined the products could not be distributed as dietary supplements and would require FDA approval as a new medicine. Some states have considered dietary supplements to be food products, as they typically carry nutrition facts labels rather than dietary facts labels or drug facts labels.
By law, the dietary supplement label must first identify the product as a dietary supplement, provide nutritional information in the form of supplement facts, separately identify any ingredients that are not listed on the supplement facts panel, give the name and address of the manufacturer, packer, distributor, and indicate the net amount of content. By law, the label of the dietary supplement must first identify the product as a dietary supplement, provide nutrition information in the form of supplement facts, list separately any ingredients not listed in the supplement facts panel, provide the name and address of the manufacturer, packager, distributor, and state the net quantity of contents. We encourage the FDA to publish definitive new dietary ingredient (NDI) guidelines, which will protect innovation and research; set forth and clarify a legitimate pathway to sell cannabis-derived cannabidiol (CBD) as a dietary supplement; establish mandatory product lists, which will ensure transparency to regulators and consumers; and resolve issues regarding N-acetyl-l-cysteine (NAC) and other ingredients commonly found in supplements and medications. The ephedra supplement story makes clear that it is extremely difficult for FDA to protect consumers from unsafe food products, and this is why Representatives Susan Davis, Representative John Dingell introduced H.R. 3156, The Access Act, and Food Additives.