As the result of my prior work as the Senior Scientist and Regulatory Expert at dietary supplements leading trade association, I believe that my views can contribute to the beginning of a balanced dialog about how to better improve current laws in order to provide continued ease of access to safe products to consumers. The current regulations that regulate dietary supplements are under increasing, reasonable scrutiny given the wide-ranging use of supplements by more than half the U.S. population, and well-publicized safety concerns [e.g., with Ephedra, Hydroxycut (Iovate Health Sciences International, Inc.), and dimethylamylamine (DMAA) in the last 20 years. Dietary supplements and their sometimes questionable claims about health effects–are regulated by the FDA in a way that is different from regular foods or medications. The Food and Drug Administration regulates dietary supplements safety, manufacture, and labeling, while our partners at the Federal Trade Commission are responsible for overseeing advertising of these products.
In addition, if the label includes any statement that a product will affect body structure or function, an assertion about general wellness, or an assertion about benefits related to classic nutritional deficiencies, a dietary supplement also should bear a disclaimer that Food and Drug Administration has not evaluated that statement, and the product is not intended to diagnose, treat, cure, or prevent any illness. Under DSHEA, supplement manufacturers are not required to demonstrate safety or effectiveness; Rather, DSHEA deliberately minimizes the supervision by U.S. Food and Drug Administration, and emphasizes the industrys value 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 Acts regulatory framework is mostly a post-market regime, as is most food regulation.
To legally be sold in China, each food additive has to receive the Certificate of Health Food Approval from CFDA, which indicates Chinas current emphasis on the safety and science-based evidence for functional ingredients. Dietary and herbal supplement companies are themselves responsible for evaluating the safety and labeling of their products prior to marketing, in order to make sure that they comply with all requirements under the Health and Education for Supplements Act. Dietary supplements are classified by the FDA as one class of food products, where the labeling of contents and claims of purpose, safety, or effectiveness are considered to best constitute marketing. These only apply to supplements that contain vitamins and/or minerals, in which those products are regulated as foods, and address supplement ingredients, including their safety, purity, and bioavailability.
In Australia, most food supplements are regulated in a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and are regulated by food authorities. Some supplements contain base ingredients such as protein or multivitamins. Studies have shown that almost two out of three active duty personnel use some type of dietary or herbal supplement on a daily basis.
Marketers and advertisers frequently target service members with brightly colored logos and ad hominem claims for these supplements. You will also find brands and names that market these supplements.
It is in the hands of the supplement manufacturers to make sure that their products are safe for use, since the FDA cannot screen everything in the modern marketplace. As an organizing body of standards committed to public health, the U.S. Pharmacopeia supports the manufacturers of food additives in continuing their efforts to produce high-quality products to meet the needs of consumers. It is my view that dietary supplements are inadequately regulated in the U.S.; however, these products should remain regulated as a subcategory of traditional foods, with the goal of maintaining compliance with the scores of other influential food laws and regulations specific to particular products and/or ingredients (e.g., regulations for fish and seafood products within the U.S. should remain in place to apply to dietary supplements).
In certain circumstances, excess vitamin and mineral intake can be detrimental or produce undesirable side effects; thus, maximum levels are needed to assure safe supplementation with foods. In 2005, Codex Alimentarius adopted guidelines on vitamins and minerals for food supplements. It should be noted that food additives were exempted before 2005, when South Dakota revoked its exemption.
SS 12-36-2120(10) provides an exclusion for foods eligible for federal food stamp programs. SS 77.54 (20N)(A) gives exemptions, and also which items are included as foods and ingredients of foods. SS 67-6-228 provides a distinction between low-tax rates and high-tax rates on food products.
Texas does not typically impose sales tax on vitamins and supplements. Purchases made under a specific women, infants, and childrens Supplemental Nutrition Program established under U.S.C. Foods, such as products made from acidophilus bacteria, soymilk, yeast from bakers, rosehip powder used to prepare tea, sunflower seeds, and wheat germ, would qualify as foods. They took action on any unsafe supplements reaching the public. Target is the reason that, in order to combat any misinformation related to health, CHAMP has created an online resource called Operation Safe Supplements. Now, this is complicated further by the fact that the FDA has many sitting bureaucrats that detest dietary supplements and who would like to see dietary supplements get premarket approval, thereby driving down the costs of vitamins, minerals, even herbal products.