New York Attorney General Accuses 4 Major Retailers of Selling Adulterated Supplements
With all the media grandstanding going on consumers would hope that there is an opportunity for change and improvement in the dietary supplement industry, but politicians and the media are blowing it already.
Many of you have read about the New York State Attorney General accusing four major retailers of producing and selling fraudulent dietary supplements. While I’m not going to discuss the accusations themselves at this time, I will discuss the bigger problem; how can we keep fraudulent and adulterated supplements off the market.
Commentators and politicians are in a frenzy blaming lack of regulation over the dietary supplement industry and are demanding more laws to help keep fraudulent supplements off the market. The 1994 law that is now being blamed for deregulation and the complete demise of dietary supplement oversight is called the DSHEA Act. Anyone who understands DSHEA realizes that it has absolutely nothing to do with this particular issue and is no more than a distraction to keep our focus off of the real problem.
Section 9 of the 1994 DSHEA act gave the FDA the authority to establish GMP (Good Manufacturing Practices) regulations for manufacturing of dietary supplements. In August of 2007, cGMP regulations for the dietary supplement industry went into effect. Every aspect of manufacturing dietary supplements is now strictly regulated by the FDA under the CODE OF FEDERAL REGULATIONS Title 21 PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS.
To claim that the industry is completely unregulated is blatantly false and the media is misleading the public. CFR 21 Part 111 regulates the manufacturing, packaging, labeling, and storage of dietary supplements. Part 111 was structured similarly to its drug regulation counterpart Part 211. These regulations make the manufacturing process and controls of a dietary supplement almost as strict as those for manufacturing a pharmaceutical drug.
These GMP regulations require analytical testing of raw ingredients to prove specifications for purity, strength, composition, and identity are met before being released into production. CFR 111 requires that a finished product be free of contamination, not adulterated and be analytically tested to prove out label claim before being released to the public. These regulations are crystal clear: what is stated on the label better damn well be in the bottle.
In the last few days, I have witnessed dozens of commentators and so-called experts attacking the dietary supplement industry but no one has ever mentioned the existence of CFR 111. It’s as if these GMP regulations for manufacturing dietary supplements do not exist. I can personally vouch for the fact that they do exist as NutraBio has had three full FDA GMP audits so far. These aren't cursory visits either; our average audit has been two weeks of eight hours a day grueling investigation by 3 FDA inspectors. In 2014 the FDA did 600 domestic and 100 foreign dietary supplement inspections.
To protect consumers we need to address the real problem and stop bullshitting the public about the need to add regulations and change DSHEA. The problem is that Congress passed strict dietary supplement regulations in CFR 21 Part 111, but did not provide adequate funding to the FDA to enforce it. In other words, the FDA has bark but not enough bite. Everyone is blaming this problem on deregulation when the true problem is regulation without adequate enforcement.
DSHEA deals with among other issues the efficacy of a particular dietary ingredient and whether it is safe to be sold to the public whereas cGMP CFR 21 Part 111 regulates the manufacturing, purity, and safety of finished products. There is no accusation by the NYAG that echinacea, gingko biloba or any of the other dietary ingredients referenced in the complaint are safe for human consumption; the accusation is that the finished products should have contained these ingredients but did not contain them in the dosage that appeared on the label. According to the NYAG, these products were therefore adulterated and fraudulent. Changing DSHEA won't prevent this in the future, enforcement of CFR 21 Part 111 will.
If these four retailers produced dietary supplements that do not meet label claim or are adulterated, then they are not in compliance with current Federal regulations. The FDA at this point should audit these manufacturers and if they are found to be non-compliant they should use everything within their powers to protect the public. On the other hand, if the FDA finds that these products were legit and the DNA testing by the NYAG was improper, which very well might be the case, then we can't stop this discussion. As an industry, we must move forward and push for better enforcement of CFR 21 Part 111 to protect consumers and ultimately protect the future of the dietary supplement industry itself.
The public needs to understand that the dietary supplement industry is regulated and should be infuriated that those regulations are not being enforced to their full extent. Once we understand the true problem we can make a serious change to protect consumers and the industry, but throwing more regulations on top of existing, unenforced regulations won’t protect the public.
Founder / CEO
NutraBio Labs, Inc