Rules and Regulations on Limitation of Science and Innovation in Natural Dietary Supplements in Virginia and Maryland

The FDA regulates safety, manufacturing, and labelling for food additives, and our partners at the FTC are responsible for overseeing the marketing of those products first. The scope of this organization has expanded to cover all FDA centers and regulated products, including the Office of Nutritional Products, Labelling, and Dietary Supplements at the CFSAN.

For that reason, FDA will continue to strive to supplement these measures with industry and consumer education efforts, and continue to provide assistance to the dietary supplement industry through rulemakings and guidance documents that address dietary supplement manufacturing, labelling, and sales. The FDA regulates dietary supplement quality, safety, and labelling, while the Federal Trade Commission oversees advertising and marketing; however, there are significant enforcement challenges that still exist, and the best government oversight has yet to be achieved. The Food and Drug Administration regulates dietary supplements pursuant to the Dietary Supplement Health and Education Act of 1994, but because this obsolete legislation has major gaps, the Agency is not effective or efficient at protecting the public’s health.

In addition, manufacturers are not required to submit product safety data to FDA prior to marketing a dietary supplement, except when that supplement contains a novel dietary ingredient (a dietary ingredient not sold in this country before Oct. 15, 1994) that has not been preserved in the food supply as a food commodity, such as a food in a form that has not been chemically altered. These federal provisions, as written, also contain a loophole, in that a store may sell any amount of CBD that they wish, so long as they make no health claims on their products, place it in food, or place it in dietary supplements. A mandatory product listing requirement is a low-cost, low-burden solution that will make sure FDA has the information needed to adequately police the supplements market.

Rules and Regulations on Limitation of Science and Innovation

We encourage the Agency to publish a final new dietary ingredient (NDI) guidance offering protections to innovation and research; to set out and clarify the legal pathway for hemp-derived cannabidiol (CBD) as a food additive; to implement a mandatory product listing that provides transparency for regulators and consumers alike; and to address issues regarding N-acetyl-l-cysteine (NAC) and other ingredients shared between supplements and drugs. We urge the agency to release final New Dietary Ingredient (NDI) guidance that offers protection for innovation and research; to establish and clarify a legal path to market for hemp-derived cannabidiol (CBD) as a dietary supplement ; to implement a mandatory product listing that provides transparency for regulators and consumers alike ; and to address the issues around N-acetyl-L-cysteine (NAC) and other ingredients that are shared among supplements and drugs. By the second half of 2021, in anticipation of improvements from an ongoing global pandemic, to focus on modernization of the 1994 Dietary Supplement Health and Education Act (DSHEA), to focus attention on the potential use of pesticides in foods, and to focus attention on the continued debate over pesticides used in foods, to focus on pesticides, to focus on labelling added sugars added to foods, to further discuss the added sugars added to foods, to address on-going discussions about added sugars. The goal of the meeting is to explore whether the current dietary supplement regulations appropriately inform and protect American consumers about potential negative health risks associated with use of some supplements.

This scientific advisory by the American Heart Association describes both innovative approaches for developing healthy, sustainable food systems, as well as the current evidence base on associations between those approaches and positive changes in diet behaviours, food intake, and, where available, health outcomes. The American Heart Association advises healthy people to obtain adequate nutrients through eating a variety of foods, not through supplementation. Despite uncertain benefits from vitamin supplementation, the Dietary Guidelines for Americans (2010) recommends that nutrients are obtained mainly from foods and provides guidelines for eating a nutritious diet.

The Academy of Nutrition and Dietetics (formerly known as the American Dietetic Association) noted in a 2009 position statement that while multivitamin supplements can be helpful for meeting recommended levels of certain nutrients, there is no evidence they are effective for preventing chronic diseases. For five decades, Americans have consumed greater than the recommended amounts of dietary sodium, despite recommendations to lower intake by reputable public health institutions. Improving compliance requires innovations that efficiently reduce the pervasive use of sodium in a food supply that is heavily processed for marketing. For 5 decades, Americans have consumed more than the recommended amount of dietary sodium, despite recommendation reductions from authoritative public health agencies.

 Improving adherence requires innovations that effectively reduce the ubiquitous use of sodium in the food supply that is highly processed commercially. In addition, retailers, restaurants, institutions, and workplaces may achieve healthful intakes through marketing and nudging strategies by increasing healthier choices among consumers. Point-of-purchase interventions promoting healthier food choices at restaurants, supermarkets, workplaces, and schools resulted in changes in eating choices, but data about health outcomes are lacking. With over 90,000 different supplements on the market, it is difficult to know which are safe and which are not.

Because supplements are not as well-regulated as pharmaceutical drugs, we cannot usually tell exactly what effects these supplements are having on your heart. The survey also found that roughly half of adults overestimate the FDAs oversight of supplements, incorrectly thinking that the agency reviews or tests those products before they hit the market. When told that is not true, seven-in-ten said that FDA cannot keep consumers safe from unsafe supplements.

Last year, FDA and the Federal Trade Commission (FTC), which enforces antitrust and consumer-protection laws, sent over 100 joint alert letters to supplement manufacturers selling products that made fraudulent claims about treating or preventing the COVID-19 pandemic. Advertising and marketing Advertising is a major enforcement area, as almost two-thirds of people in the U.S. report being exposed to ads about supplements. The Federal Trade Commission regulates supplements ads, including print and Internet ads, infomercials, catalogs, and other materials from manufacturers, to ensure that ads are truthful, non-misleading, and justified. It is difficult to forecast FDAs ability to inspect and enforce regulatory requirements on dietary supplements in 2021 because of the still uncertain nature of COVID-19 and associated variables, such as availability of the vaccine(s). Two critical issues to be addressed are FDAs failure to understand which supplements are available in the marketplace and its failure to order the withdrawal of supplements products that contain pharmaceutical ingredients.