The dietary supplement, functional food, and natural products industries in the United States are facing numerous regulatory uncertainties with the start of 2021, which is marked by a new US Administration, ongoing global pandemic, and much more. Not surprisingly, the nutrition and dietary supplement industries are responding with a focus on developing new products and repositioning older products in order to help consumers manage their health. The U.S. dietary supplement industry has grown from approximately 4,000 products in 1994 to an estimated 50,0000 to 80,000 products as of FY2021,1 and about 80 percent of U.S. adults reported taking dietary supplements, according to a Consumer Reports 2021 Consumer Survey. These increases in the number of products and in consumers use highlight the importance for physicians to be aware of potential concerns regarding product quality when presented as dietary supplements, given the U.S. Food and Drug Administration (FDA) does not rigorously regulate supplements like drugs. It is difficult to project FDAs ability to inspect and enforce regulations on dietary supplements in 2021 because of the still uncertain nature of COVID-19 and associated variables, such as vaccine (s) availability.
By the second half of 2021, barring improvements due to an ongoing global pandemic, we might expect to see focus on the modernization of the Dietary Supplement Health and Education Act (DSHEA) of 1994, potential legislation regarding cannabis-derived cannabidiol (CBD) as a dietary supplement, an emphasis on pesticides used in foods, and continued discussions regarding labeling added sugars in foods, and continued discussions regarding added sugars. We urge the agency to issue final guidance on new dietary ingredients (NDIs) that provides protections for innovation and research; establish and clarify a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement; implement a mandatory product listing that provides transparency to regulators and consumers alike; and address concerns about N-acetyl-l-cysteine (NAC) and other ingredients that are shared between supplements and medications. The Commission should undertake research into, and make recommendations regarding, regulating label claims and statements on dietary supplements, including use of literature related to dietary supplement sales, and procedures to evaluate those claims. The Health Functionality Claims Catalogue broadens the scope of regulation, giving CFDA oversight over both finished products and their ingredients.
Dietary Supplements
Structure-function claims can be used immediately, without FDA approval, though supporting data must be submitted to the FDA, and the first 30 days of a supplements marketing must be filed. FDA premarket approval, based on substantial science supporting safety and effectiveness, is required for new claims about nutrient composition or for new health claims, both for conventional foods and for food additives. Foods intended for specialty diets need prior FDA approval, but health foods need no pre-market approval or notice.
In Australia, most food additives are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered special-purpose foods and regulated by food authorities. In the European Union, food supplements are regulated as foods, with the legislation focused on vitamins and minerals used as ingredients of food supplements. These only apply to supplements containing vitamins and/or minerals in which those products are regulated as foods, and address the ingredients of supplements, including their safety, purity, and bioavailability.
Dietary supplements are included under the health functional foods (HFF) category in South Korea, regulated by the Ministry of Food and Drug Safety (MFDS) according to the HFF Act, in order to promote safety. The 1990 Nutrition Labeling and Education Act (NLEA) allows claims for preventing diseases for foods, but only after a product has been evaluated according to FDA regulations. Under the Nutrition Labeling and Education Act (NLEA) of 1990, Congress created new mandatory and voluntary means for marketers of foods and food additives to provide consumers with nutrition information.
The NLEA and the regulations it implemented, for example, mandated, for the first time, that product labels disclose specific nutritional information, such as the daily value needed for specific nutrients for good health. The NLEAs nutrition labeling regulations are broad, providing a conspicuous panel for nutritional facts, daily reference values, ingredient statements, and nutrition and health claims. Neither NLEA, DSHEA, or any of the other laws or regulations that regulate construct/function claims has ever required that, as part of their evidence obligations, food and supplement manufacturers should try to address the question of whether or how a consumer may achieve or exceed the nutrient-daily reference value.
Under U.S. law, a food additive is considered a violation if it is represented (e.g., in the products labeling) to conform with the standards found in USP-NF, but fails to do so. This situation may potentially create an incentive for manufacturers to make claims about whether their dietary ingredients or supplements meet a government-based quality standard, as contained in the USP-NF, because if a product does not in fact conform. Under US law, a dietary supplement shall be deemed violative if it is represented (eg, on the products labeling) as conforming to a standard in the USP-NF but fails to so conform. This situation potentially creates a disincentive for manufacturers to claim that their dietary ingredient or supplement meets a public quality standard, such as one contained in the USP-NF, because the product could be deemed misbranded if it does not actually conform to a public quality standard.6. To legally sell in China, each food additive must receive the Certificate of Health Food Approval from CFDA, which indicates Chinas current greater emphasis on the products safety and scientific evidence for function.
Such regulations should be modeled after the existing Good Manufacturing Practices regulations for foods, and cannot enforce standards that do not have current, commonly available analytical methodologies. In 1997, the Food and Nutrition Board of the Institute of Medicine updated and expanded the recommended dietary allowances (RDAs) for calcium. Many nutritional and non-nutritive antioxidants, including vitamins A, C, and E, and selenium, coenzyme Q10, and other phytochemicals, such as anthocyanins, are being integrated into functional foods due to their broad array of nutritive and non-nutritive health benefits.