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FDA and Dietary Supplements

Friday, May 04, 2012

Misconceptions, too often fueled by blatant misreporting by the main stream press, have led the public to believe that the dietary supplement industry is not regulated by the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC).  This is simply not true.
Dietary supplement manufacturers must comply with a host of federal and state regulations involving ingredient safety, manufacturing, quality control, labeling, advertising, bioterrorism, and post-marketing surveillance.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) was enacted by unanimous consent in Congress. This law specified that dietary supplements: vitamins, minerals, botanicals, sports nutrition, weight management and specialty supplements would be regulated as a category of food. DSHEA also provided provisions that went beyond conventional food regulation and provided FDA with more, not less, authority over supplements than it had previously.
Under DSHEA:

  • FDA has the authority to remove from the market adulterated or unsafe products.

  • If a product contains an ingredient not listed on the label (or if an ingredient on the label is not listed in the product at the claimed amount), the product is adulterated and FDA can impose sanctions on the company, ranging from imposing fines to removing the product from the marketplace to criminal prosecution of the manufacturer.

  • By law, dietary supplement manufacturers must adhere to Good Manufacturing Practices (GMPs) specific to dietary supplements which go beyond conventional food GMPs and cover virtually all aspects of supplement manufacturing, labeling, and quality control. Products that are not made according to the GMPs can be deemed adulterated or misbranded by FDA.

  • Dietary supplement manufacturers must notify FDA before they introduce a new ingredient to the marketplace and must have evidence of safety in support of the new ingredient.

  • Advertising and labeling for dietary supplements must be truthful and not misleading to consumers. FDA, FTC, and state agencies and attorneys general all have enforcement authority and have exercised that power with large civil fines and penalties.

Additionally, dietary supplement manufacturers must notify FDA within 15 days of any serious adverse event reports they receive, a requirement comparable to prescription and some over-the-counter drugs, but not conventional foods.

It is true that dietary supplement products do not have to undergo the same pre-market approval process as that required for drugs; however, pre-market approval does not always provide a guarantee of safety, as we have seen with so many FDA approved prescription drugs.

Ellen Troyer, MT MA
Biosyntrx CEO / Chief Research Officer


Biosyntrx formulations are manufactured to NSF certified Good Manufacturing Practice (GM)P standards in the USA. 

NSF certification guarantees that all regulatory requirement guidelines for processes, procedures and documentation that assures products produced have the identity, strength, composition, quality and purity they claim d to possess. 


Clinical references available in the Biosyntrx office.