Spare the rod, spoil the industry.
Dietary supplements industry (Cases)
|Publication:||Name: Alternative Medicine Review Publisher: Thorne Research Inc. Audience: Academic; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 Thorne Research Inc. ISSN: 1089-5159|
|Issue:||Date: Dec, 2011 Source Volume: 16 Source Issue: 4|
|Topic:||Event Code: 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Company legal issue|
|Product:||Product Code: 2834730 Nutrient Preparations NAICS Code: 325412 Pharmaceutical Preparation Manufacturing SIC Code: 2833 Medicinals and botanicals; 2834 Pharmaceutical preparations; 2023 Dry, condensed, evaporated products|
|Organization:||Company Name: Syntec Inc.|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
Recent activity by the U.S. Food and Drug Administration (FDA) has
demonstrated their seriousness in stepping up the level of enforcement
for dietary supplement manufacturers.
On December 1, 2011, U.S. Marshals seized all the dietary supplements from Syntec, Inc., a Wisconsin manufacturer. Two reasons were given for this action. One was that the manufacturer did not comply properly with a warning letter issued in 2009, and continued to make disease claims for some of their products (i.e., the FDA alleged they were marketing some of their products to prevent, treat, or cure diseases). The second reason was a failure to address serious current Good Manufacturing Practices (GMP) violations noted during inspections in 2010 and 2011.
In November 2011, Quality Formulation Laboratories and American Sports Nutrition, as well as five individuals in ownership and management positions, were banned from manufacture or distribution of dietary supplements. The individuals were fined and sentenced to prison for a minimum of 34 months. In addition to cleanliness and GMP issues, the defendants, while acting under a civil consent decree, violated that decree by setting up another supplement plant to continue manufacturing in an effort to bypass the spirit of that decree.
These are but a few of the recent FDA actions of note. In speaking with members of the FDA, I was left with the impression that the level of demand for compliance is about to rise quickly. The failure of some industry members to comply with even basic GMP and hygiene procedures has now gone on for a sufficient amount of time. I believe the hammer is about to fall on more and more of these non-compliant industry members.
It would seem to me that, given the nervousness of some industry members, manufacturers, and distributors concerning the increased FDA activity, and the exposure of those members, consolidation of companies and labels might be in the near future for some dietary supplement industry players. There are people/companies who (1) are now aware that they are not compliant, and (2) are not willing or able to make the investment necessary for compliance. They will either shut down in the next year or two, or hold on until threatened with compliance issues or regulatory letters and fade at that point.
Make no mistake, the FDA and their compliance requirements are not going away. It will be the dietary supplement industry that will need to quit being the bad child, or the stick will loom ever larger.
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