The 1994 Dietary Supplement Health and Education Act (DSHEA) established certain specific regulations and procedures to address health claims and two related types of dietary supplement labeling claims, claims about general health and claims about nutritional deficiencies. In addition, if the label includes a claim that a product affects body structure or function, a claim of general well-being, or a benefit claim related to a classic nutrient deficiency disease, dietary supplements also must bear a disclaimer that indicates the Food and Drug Administration has not evaluated these claims, and the products are not intended to diagnose, treat, cure, or prevent any illness.
In addition, if the labeling includes a claim that the product affects the structure or function of the body, a claim of general well- being, or a claim of a benefit related to a classical nutrient deficiency disease, a dietary supplement must also bear a disclaimer stating that Food and Drug Administration has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease. Even if it were required, evidence supporting a claim that supplements are used is ambiguous. While supplement products can not be marketed to treat or prevent disease claims can only describe how a particular nutrient or dietary ingredient affects the structure or function of the body manufacturers are not required to submit evidence to the agency that substantiates the claims they make about their products. Even if they were to do so, the evidence supporting the use of dietary supplements is mixed. This leaves the agency without clear visibility into what is available in the marketplace at a given moment.
In the U.S., supplement safety is regulated by the U.S. Food and Drug Administration (FDA), but legal limitations inhibit FDAs ability to regulate dietary supplements effectively (e.g. This has increased risks to public health, and has led to many calls for reform. Under DSHEA, supplement manufacturers are not required to demonstrate safety or effectiveness; instead, DSHEA deliberately minimizes the US Food and Drug Administrations oversight, focusing on the value of the industry to the U.S. economy. The DSHEAs fundamental framework allows for all products that were sold as food additives at the time of enactment of the act to remain on the market, except where FDA can demonstrate a safety issue in a specific product or product line this is what is called the grandfather clause; manufacturers are required to inform FDA before marketing any new ingredients. The Chinese Food and Drug Administration (CFDA) subsequently implemented changes in regulatory systems, covering registration and notification processes, creation of the Health Benefits Claim Catalogue and an Ingredient Catalogue for Health Products, and labeling.
At the time, FDAs issued notices to 10 companies in the food additives industry, who, in its view, were unlawfully marketing food additives in the marketplace that contained drug-like claims. Since this initial wave, FDA has issued over 50 notices stating its view that some claims related to mental health are not approved drug claims. At the time, FDAs issued warning letters to 10 dietary supplement companies, which it contended had illegally sold dietary supplements marketed with drug claims.Since that initial sweep, FDA has issued more than 50 warning letters in which it took the position that certain mental health-related claims were unapproved drug claims. In a press release announcing the letters release, the agency conveyed its concerns about these claims, saying [d]ietary supplements claiming to treat, treat, alleviate, or prevent depression and other mental health conditions are new, unapproved drugs, which can potentially harm consumers using such products rather than seeking proven treatments from a qualified healthcare provider. For example, on 19 February 2021, FDAs issued warning letters to 10 companies, which the agency alleged had unlawfully sold dietary supplements intended to treat or prevent depression and other mental health disorders.In the agencys press release announcing issuance of the letters the letters, it communicated concern regarding such claims, stating that [d] ietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders are unapproved new drugs that could potentially harm consumers who use these products instead of seeking proven treatments from qualified health care providers. FDAs have also explicitly stated or implied claims claiming a food additive is an indication that the supplements may treat or prevent specific mental health conditions, including serious depression or anxiety, are medical claims, a health supplement is an indication of medical benefit. FDA has issued guidance regarding the temporary procedures for qualifying health claims (see Temporary Procedures for Qualifying Health Claims in Labeling Conventional Human Foods and Human Drug Supplements) and on the scientific criteria that FDA uses when conducting evaluations of health claims (see the Science-Based Review System for the Scientific Evaluation of Health Claims).
For example, the FDAs Statement of Identity, Nutrition, and Ingredients for Dietary Supplementss small entity Compliance Guidance discusses complying with Agency regulations that implement the provisions of the Cures Act; and using resources, continuing to coordinate with other Federal and State entities involved in the fight against health fraud. The Nutrition Labeling and Education Act of 1990 (NLEA) provides for the use in food labeling of health claims that describe the association between food, food ingredient, or food component and the risk of a disorder (e.g., Adequate amounts of calcium over a lifetime can lower the risk of osteoporosis, provided that these claims meet specific criteria and are authorized by an FDA regulation. Dietary supplements are included under the health functional foods (HFF) category in South Korea, which is regulated by the Ministry of Food and Drug Safety (MFDS) pursuant to the HFF Act, in order to promote safety. The European Food Safety Agency (EFSA) added, Consults can be used for correcting a nutrient deficiencies or maintaining adequate nutrient intake. The primary EU law is Directive 2002/46/EC, which covers dietary supplements that contain vitamins and minerals. In certain cases, excess consumption of vitamins and minerals can be harmful or produce undesirable side effects; thus, a maximum amount is needed to guarantee safe use of them in food supplements. By the second half of 2021, in anticipation of improvements due to an ongoing global pandemic, we may expect to see focus on the modernization of the 1994 Dietary Supplement Health and Education Act (DSHEA), potential legislation on cannabis-derived cannabidiol (CBD) as a food additive, an emphasis on the use of pesticides in foods, and continued discussions about labeling added sugars in foods. At least three members of the Committee should be qualified through scientific training and experience to assess the health benefits of the use of dietary supplements, and one of those three members should be trained in pharmacognosy, medical botany, traditional herbalism, or other relevant sciences.