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The FDA and Supplement Regulation

There is way too much confusion with regard to the FDA and Supplement Regulation.

"FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products."

Key points:

1. "Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded."

2. "... firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations."

3. "Although dietary supplement manufacturers must register their facilities with FDA,* they are not required to get FDA approval before producing or selling dietary supplements. Manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading."

4. Companies "must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control."

5. The manufacturer "is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States."

What is the bottom line? Is there oversight? Yes, but ... it could be much better. It leaves the door open for companies to produce fraudulent products and simply wait until they get caught.

Caveat emptor - let the buyer beware. Are there companies that produce properly tested products? Yes! How does the consumer really know? Very difficult.

If you cannot answer the following questions about the supplement company and product(s) you use, then you may wish to consider a company and product which meets all these important qualifications.

In other words, if it was your child, would you pay attention to this?

  • Are your supplements safe?

  • Where are your supplements produced and is the company on the label really the manufacturer?

  • Has every batch of your supplements been tested for 500 contaminants?

  • Are you aware of any safety complaints against your supplements?

  • Are your supplements guaranteed to work?

  • Is there a scientifically validated method of measuring the effectiveness of your supplement?

  • Is what is on the label really in the bottle?

  • Are the best ingredients selected and used?

  • Are these ingredients in the proper formulation to really provide health benefits?

  • Are the raw materials tested prior to their use in formulating the supplement?

  • Does the company have a scientist who is responsible for actually going to each raw material supplier to inspect the shipments?

  • Has the chemical structure of each ingredient been identified and tested?

  • Does your supplement have the active ingredients that really offer health benefits?

  • Are these active ingredients standardized for consistent efficacy and quality?

  • Has your supplement been substantiated with scientific clinical studies?

  • Does the company who produces your supplements have a large number of in-house scientists from multiple disciplines who are responsible for the research and development of the products they make?

  • Does the company who produces your supplements have a volunteer (unpaid) scientific board of advisors that includes the top nutrition and anti-aging scientists in the world?

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