Hot New FDA Supplement News!
FDA’s Nutritional Supplement Regulations
On June 22, 2007, the Food and Drug Administration (FDA) announced a final rule establishing current good manufacturing practices (cGMPs) for dietary supplements. This is great news for consumers of nutritional supplements.
Under the FDA’s nutritional cGMP rule, nutritional supplement manufacturers are required to:
- Employ qualified employees and supervisors.
- Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding.
- Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use.
- Establish and use master manufacturing and batch production records
- Establish procedures for quality control operations.
- Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected.
- Keep a written record of each product complaint related to cGMPs.
- Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.
As of June 2008, the new FDA regulations for supplement manufacturing will be in full affect for companies with more than 500 employees. Those companies with less than 500 employees have until June 2009 to comply. Finally, those with fewer than 20 employees have until June 2010 to comply with the regulations.
As readers know, Deflame.com makes available nutritional supplements manufactured by Anabolic Laboratories. This is because Anabolic Laboratories has exceeded the June 2008 FDA manufacturing guidelines since the 1950s! How can this be?
It is because Anabolic Labs has been manufacturing pharmaceuticals since the 1950s, and they have been manufacturing supplements to the same pharmaceutical cGMP standards since that time. So, while many companies will begin marketing the fact that they have invested millions of dollars to become compliant with the FDA’s new nutritional manufacturing standards, it should be understood that Anabolic Labs has exceeded the 2008 nutritional cGMPs since the mid 1950s, when Anabolic became compliant with the more comprehensive pharmaceutical cGMPs..
You are likely to hear or read complaints about government intrusion into supplement manufacturing; however, it is important to realize that such complaints are coming from those that are manufacturing inferior products without appropriate quality control. However, there are voices of reason within the supplement manufacturing industry that feel the new FDA cGMPs are appropriate.
The Natural Products Association (NPA), formerly called the National Nutritional Foods Association (NNFA), developed a voluntary GMP program to help upgrade the quality of supplement manufacturing. The NPA is a 75 year-old organization and according to Daniel Fabricant, its president of scientific and regulatory affairs, "this is going to be good for the industry." The NPA’s voluntary GMP program has been in existence since 1999 and Anabolic Labs was in the first group of companies to receive the NPA GMP. In fact, the modestly stringent NPA GMPs were derived from the pharmaceutical GMP program of Anabolic Laboratories.
Up until now, the supplement industry can be likened to the Wild, Wild West in the days of Wyatt Earp. It has been an essentially lawless industry, without external regulations to ensure quality and safety. Supplement manufacturers have operated until now as food manufacturers, and have not been held accountable for manufacturing processes and the assurance that, “what is on the label, is actually in the pill.”
The FDA has detected numerous quality and manufacturing problems with nutritional supplements in recent years. The new cGMPs aim to ensure that dietary supplements do NOT have:
- wrong ingredients
- too much or too little of a dietary ingredient
- improper packaging
- improper labeling
- foreign materials in a supplement container
- contaminant (e.g., bacteria, pesticide, glass, lead)
Allan Wilson, the National Manager of Anabolic Laboratories, sees the cGMPs as a needed measure to improve the industry. Wilson states:
“Perhaps 70-90% of the manufacturers may cease to exist within the next 10 years. It will not be worth the penalties associated with noncompliance, and most manufacturers will not be willing to spend the millions of dollars needed to be become compliant. As for Anabolic Labs, the nutritional cGMPs will have no effect on us. This is because we have exceeded the new nutritional cGMPs for over 50 years [since the mid 1950s], when we began manufacturing pharmaceuticals and applied the majority of the pharmaceutical cGMPs to the manufacturing of nutritional supplements.”
Up until now, the FDA never set foot into a nutritional manufacturing facility for the purpose of inspection. In contrast, the FDA regularly inspects pharmaceutical manufacturers.
The new cGMP legislation is set to provide standards specific to the nutritional supplement industry for FDA inspectors to check for purity, safety and legality in manufacturing. Consumers should be happy that a significant measure has been taken to ensure supplement quality and safety.
Click here for a copy of the new law as written in the Federal Register.
Click here for a summary from the FDA regarding the background development of the new rules.
Click here for a summary from the FDA about the Final Rules for the new nutritional cGMPs.