FDA has funded a framework from the Food and Nutrition Council at the Institute of Medicine that would enable the agency to prioritize additional studies on food additives, including weight-loss supplements, identifying the ingredients that are most concerning. The board is expected to study, and make recommendations about, regulating label claims and statements on dietary supplements, including use of literature related to dietary supplement sales, and procedures to evaluate those claims. At least three members of the Commission shall be qualified through scientific training and experience to assess health benefits from use of dietary supplements, and one such three members shall be experienced in pharmacognosy, medical botany, traditional herbalism, or other relevant sciences. Dietary and herbal supplement companies are responsible for their own evaluations of the safety and labeling of their products prior to marketing, in order to assure compliance with all requirements of the Dietary Supplement Health and Education Act.
To maintain the products status as a dietary supplement, labeling should comply with provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA). The 1994 DSHEA permits labeling herbal products with statements explaining their claimed effects on the structure or function of the human body (e.g., relieving fatigue) or their role in contributing to overall wellbeing (e.g., improving mood or mental functioning). Analysis of some herbal products claimed effects has shown they are at times highly similar to claims about clinical effectiveness in addressing a variety of diseases or conditions. The popularity of safer food additives, and concerns about regulating them, is what led to the passage of this legislation in 1994, legislation which Senator Harkin and I were proud to co-authored with the current governor of New Mexico, Bill Richardson. Dietary supplements — and their sometimes questionable claims about their health effects — are regulated differently from regular foods or medicines by the Food and Drug Administration.
Dietary Supplements
The underlying framework of DSHEA allowed for any products that were sold as diet supplements at the time of enactment of the law to remain on the market, except where FDA can demonstrate a safety issue with the specific product or product line — that is what is called a grandfather clause; manufacturers are required to inform the FDA before marketing any new ingredients. The bill placed dietary supplements under a specific subcategory within the umbrella of foods generally, but products falling within a medication definition are regulated as medicines. FDA, which regulates weight-loss supplements manufacture and labeling, took 16 actions against manufacturers during this same time.
Federal surveillance includes conducting enforcement actions against companies, funding studies that assess weight loss supplements, and providing education about potentially harmful ingredients and fraudulent product claims. For example, FDAs Statement of Compliance for Small Entities on Identification, Nutrition, and Labeling of Ingredients of Dietary Supplements discusses complying with Agency regulations that implement the labeling provisions of the law; and using resources through ongoing coordination with other federal and state entities involved in addressing health care fraud. The Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) Food and Drug Administration (FDA) each have oversight responsibilities over products marketed as weight loss supplements.
No, other than regulations described above that regulate new dietary ingredients, there is no provision in any statute or rule FDA applies requiring a company to disclose to the FDA or consumers the information it has regarding the safety or alleged benefits of its dietary supplement products. Except for new dietary ingredients, in which premarket reviews of safety data and other information are required by law, a company does not need to submit to FDA evidence that it relies upon to support safety or efficacy before or after marketing its products. In addition, manufacturers must register themselves with FDA as part of the Bioterrorism Act before producing or marketing supplements. This new law, which amends the federal Food, Drug, and Cosmetic Act, establishes a new regulatory framework for dietary supplement safety and labeling. Under DSHEA, a company is responsible for determining that dietary supplements that it makes or distributes are safe, and that any statements or claims made about them are supported by sufficient evidence showing that they are not false or misleading.
As we have stated before, publication of the final GMP regulations would enhance FDAs ability to enforce, because DSHEA provides that dietary supplements that are not manufactured in accordance with GMPs will be considered adulterated. If GMPs are regulated, FDA could bring an enforcement action against manufacturers of adulterated products. Such regulations should be modeled on existing good manufacturing practice regulations for foods, and may not mandate standards for which no currently applicable, commonly available analytical methodologies exist. Whenever an amendment or repeal is expressed in this Act by way of amendment of, or repeal of, a section or other provision, reference shall be taken to be made to the section or other provisions of the Federal Food, Drug, and Cosmetic Act.
The U.S.P. DSC also includes General Chapters related to Good Manufacturing Practices that manufacturers may utilize to assist them in assuring their supplements are made using safe, sanitary, and well-controlled manufacturing practices. The USP Dietary Supplements Compendium (DSC) is your one-stop shop for all of your quality needs in the DSC, including necessary analytical tools, such as monographs, general chapters, and chemical reference standards, for conducting necessary identity, potency, purity, and potency tests. OPSS includes the Ask an Expert feature, which allows users to submit questions on supplements directly to healthcare experts. Studies have shown that almost two out of three active duty personnel use some type of daily food or herbal supplement. Omega-3 supplements are fairly safe, and they can enhance other aspects of health, like your lipid profile.