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August 19, 2011
With the passage of 1994's Dietary Supplement Health Education Act in 1994, common sense would have dictated that the entire supply chain associated with development and production of dietary supplements would have been subjected to the rigorous standards now associated with the Good Manufacturing Practices enumerated in 21 CFR 111.
Such a conclusion is erroneous: the raw material producers and providers were exempted from the requirements for quality standards and practices prior to passage of the law. In fact, not until the recent adoption of FOSMA (Food Safety Modernization Act), were raw material ingredient suppliers subjected to any significant standards now associated with DSHEA.
Consequently, the producer of the supplement, largely consisting of contract manufacturers for non-vertically integrated marketing and distribution firms, is legally responsible to meet the standards for purity and efficacy called for in DSHEA and companion regulations. Now that DSHEA and the related GMPs are in force, marketing companies have some serious questions (e.g., How much control over raw material sourcing and testing is given to the contract manufacturer? Who is responsible for quality control) to ask themselves.
The use of fair non-disclosure agreements written by competent counsel is a solid first step in building the trust required for a successful product development and launch. By law, the contract manufacturer must have full disclosure of the contents of the proposed product, must source and qualify the components, must test these components to warrant their suitability for human or veterinary consumption, must compound these components in a suitable manner, and demonstrate that the shelf life being assigned to the finished product container has adequate assurance through scientific means to reach expiry with adequate potency. (Many interpret the law to suggest the producer of the product cannot outsource the testing upstream to the raw material producer.)
A company that wants their supplement made has to relinquish a certain amount of control to its contract manufacturer. Consequently, a significant economic burden is attached to the contract manufacturer.
Setting up standards for testing the finished product—including record keeping and how the standards are applied—is given considerable attention by the FDA in auditing producers. Unfortunately, judging by the many 483 Filings and subsequent FDA Warning Letters, many companies aren't bothering with this impact. They should. Paying mere lip service to DSHEA requirements means an unfortunate confrontation with the industry's new reality.
The contract manufacturer now has the legal burden to produce high-quality products according to federal laws. Even affixing a label to a product falls within the purview of federal regulators. Fraudulent, inaccurate labeling will lead to serious repercussions for the supplement producer, the co-packer, and the marketer.
Ignorance isn't bliss. Failure to fully disclose component content does not excuse the contract manufacturer from their affirmative legal duty to know the product, test the product, and validate the content statements against Master Batch Documents, and product consumer labels.
Mark A. LeDoux is founder, chairman and chief executive officer of Natural Alternatives International Inc. an organization established in 1980 with facilities in the U.S. and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. He is a proud member and leader of many industry organizations.
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