By Heather VanBlarcom
General Counsel & Senior Regulatory Specialist for Dietary Supplements
Over the weekend, the Chicago Tribune quoted Dr. Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs, as stating that “It’s downright scary. At least half of industry is failing on its face.” The dietary supplement industry is reported to be a $28 billion dollar industry that provides significant benefits for its consumers. Half of all Americans are believed to consume dietary supplement products. However, continuing failure to meet the basic manufacturing standards will undermine all the industry has done to ensure that dietary supplements continue to be available to all those who value them. Unfortunately, the relatively few industry “bad apples” are the ones that get the majority of the attention. However, you can no longer cross your fingers and hope you don’t get caught or bury your head in the sand and assume you are compliant.
While you may believe you are using good manufacturing practices, the fact is that 21 CFR 111 sets forth significant and complex requirements that must be followed in the manufacture of dietary supplements. Many manufacturing companies are operating with small margins and simply do not have the personnel with the necessary experience and education to understand and implement these extensive requirements.
While 21 CFR 111 is a necessary and ultimately a beneficial regulation, it is a big eye-opener for small companies when they realize the extent of what is expected of them and the cost it can take to get them there. Trust me when I say that the cost of non-compliance is much greater both financially and to your company’s reputation. However, rest assured that, with the proper guidance, compliance can be made as painless as possible. Remember, the FDA’s objective is to obtain compliance with 21 CFR 111 not to crush and punish manufacturers. In my experience, the FDA will work with those companies who strive for compliance and are willing to commit to taking the steps necessary to achieve and maintain compliance.
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