Due to false information spread by the media, people in the medical community and so many other so-called experts on the web many people believe that dietary supplements are not regulated, unsafe and they are not put through any type of standards to ensure quality. This could not be further from the truth.
Truth is dietary supplements are regulated by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Initially in 1938 by the Federal Food, Drug and Cosmetic Act (FFDCA) and further strengthened in 1994 when Congress passed the Dietary Supplement Health and Education Act (DSHEA). Since then both the FDA and FTC have been given the power to become the watchdogs to monitor basically all aspects of the dietary supplement industry including manufacturing, labeling, marketing and ingredient safety. The FDA focuses on inspecting manufacturing facilities, reviewing labeling and policing products for safety while the FTC goes after false, deceptive and misleading advertising. The DSHEA also gives the FDA and FTC additional powers to remove any products from the market that are deemed unsafe or mislabeled and/or misleading.
Since supplements are made with natural ingredients that have a long history of human usage they are regulated as a category of food. This characteristic divides dietary supplements from prescription and over the counter drugs which consist of uncommon chemical compounds developed in laboratories that require a heightened level of regulatory attention that includes pre-market approval.
Before 2007 the FDA required dietary supplements to meet the same good manufacturing practices (GMPs) as conventional foods but today the FDA demands higher standards from raw material verification to complete product testing and accurate labeling. The new GMP standards became required for large manufacturers in 2008 and are now in effect and being enforced for all manufacturers. This is perhaps most critical aspect of regulation when it comes to ensuring safety, effectiveness and quality.
Other important regulations such as the Food Allergen Labeling Act (FALCPA) and the Dietary Supplement and Nonprescription Drug Consumer Protection Act that both went into effect in 2006. The first requires manufactures to label and clearly identify if any of the 8 common major allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, or soybeans) are container within and second act focuses on requiring manufacturers to notify the FDA of all serious adverse events (death, in-patient hospitalization, etc.) it receives associated with their dietary supplements within 15 business days.
So as you can see supplements are vigorously regulated in order to ensure products are safe and labels are truthful and accurate. Now there are supplement companies like any business that will try to break the law. The federal government can and has taken legal action against certain dietary supplement companies that have made false claims or have sold products proven to be unsafe just like they do with the food industry and pharmaceutical companies.
Claims that dietary supplements are unregulated is completely ignorant to the comprehensive regulations in place that control the industry not to mention the supplement industry’s proven track record of safety and benefit to consumers.
So the next time someone tells you supplements are not regulated you can share this article with them to give them the facts about the history of the dietary supplement industry.
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