QUESTION ON FDA

Thank you for your email and enquiries. Kindly allow me to assist you.

Do allow me to explain further on the FDA approval on health supplements.

(Quoting from FDA's website):

http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/ucm191930.htm

 
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers need to register themselves pursuant to the Bioterrorism Act2 with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

With the implementation of new US FDA Dietary Supplement Good Manufacturing Processes (GMPs) which closely resemble GMPs for pharmaceutical products, Nu Skin distributors and consumers can be confident that Pharmanex products are true to the labeled contents and do not contain banned substances of any kind. This is supported by Nu Skin’s commitment to the 6S Quality Processes, including newly established Dietary Supplement GMPs, which are a more comprehensive review and certification process.

Although dietary supplements are not registered with the FDA, "manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim. These statements may claim a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. Structure/function claims may also describe the role of a nutrient or dietary ingredient intended to affect a structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient."

More information on FDA’s website: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm
I hope this addresses your concerns. Please feel free to contact us should you need further assistance. Thank you and have a nice day!

 

Kindest Regards,

Cindy Ku

Trainer (Pharmanex)

DL: 603- 2170 7760

Fax: 603- 2170 7799