cease and desist

The Partys Over

The time for assuming others are doing the heavy lifting in raw material qualification procedures is officially over. A dialogue between the industry, from agricultural producer, to processor, to manufacturer and to retailer is long overdue, and should help all of us with a vested interest in protecting the consumer achieve a best-practices approach to risk management, while improving the confidence of all parties to this equation.

Imagine receiving a cease and desist letter from a state Attorney General (AG) claiming products you sell contain none of the listed components in the finished products. After Feb. 3, 2015, that is no longer an imaginary scenario.

Four of the largest retailers in the nation were provided these notifications seeking information from the suppliers concerning the materials used in the finished consumer products. The New York AG, presumably relying on DNA testing conducted at a Canadian University, felt compelled to inform these retailers that their products were sub-standard and therefore unworthy for commerce. Of course, the back and forth now begins and investigations launched into supply chain management, qualification, the suitability of things like DNA testing versus other methods of testing—but the damage is done.

The very disclosure in a public statement by the New York AG that DNA testing resulted in the decision to issue cease and desist letters for several common herbal products is troubling for a variety of reasons. First, DNA testing of raw materials needs to be done under controlled laboratory conditions and by qualified experts utilizing appropriate methods. If these products were extracts of herbal starting materials (plants), there is the very real probability that no DNA of the original plant may be present, just the extracted “phytochemical actives" associated with presumed health benefits. Consumers exposed to television police and crime dramas are convinced that DNA is the magic component to declare guilt or innocence in capital crimes. However, this does not necessarily translate to the issue at hand. If the starting material for the finished product is a botanical, it should be tested with a validated method of identification for that botanical.

Some companies utilize various levels of sophistication, from Infrared Spectroscopy to thin layer chromatography (TLC) to gas chromatographs (GC) or high performance liquid chromatography/mass spec (HPLC/MS). The widespread use of DNA in material identification and qualification has not been widely adopted in the dietary supplement space, a factor that will not go unnoticed by all participants of this unfolding news story. However, if starting material is not available prior to the receipt of a standardized extract from the original plant, the utilization of a DNA test to identify said plant will most likely demonstrate the absence of the plant material, because an extraction of select chemicals has already been undertaken and the starting material has been presumably discarded wherein the plant DNA will be found.

Recent work by scholars in the herbal industry has identified areas where adulteration has taken place, or is likely to take place in the future due to economic reasons. The American Botanical Council (ABC) is vigorously pursuing this effort and they are to be applauded for the work to date. But beyond this activity, we need to recognize that ever since the adoption of cGMPs (current good manufacturing practices) by FDA for dietary supplements (found as 21 CFR 111), the requirement for supplier qualification is specific. Companies engaged in making dietary supplements in the United States may rely on ingredient supplier’s certificates of analysis (CoA) to determine that all established material specifications have been met, provided the manufacturer of the finished product has qualified the supplier by establishing the reliability of the supplier’s CoA through confirmation of the results of the supplier’s tests or examinations. Furthermore, the manufacturer must demonstrate the CoA includes a description of the test or examination method(s) deployed, limits of the test or examinations, and actual results of these tests or examinations. The manufacturer must also maintain documentation evidencing how it performed its duty to qualify the supplier with evidence of periodic re-confirmation of the supplier’s CoA’s and that the manufacturer has quality control (QC) personnel review and approve the documentation setting forth the basis for qualification and requalification of any supplier.

This all seems straightforward, but nowhere in the U.S. dietary supplement cGMPs are lists of acceptable test methods or processes. While the entire process is based on common sense, the real burden is trying to anticipate areas of risk of funny business of adulteration for economic or other reasons and implementing mechanisms robust enough to catch these materials and prevent them from entering commerce to the detriment of consumers.

Recently a group of industry veterans joined with regulators from “down under" to speak to the issues of how to assure the production of quality dietary supplements at the CRN International Conference in Brisbane Australia. The full report is available as a free download from the European Journal of Nutrition (2015) 54 (Suppl. 1) S1-S8.

One quote from this work is germane to this discussion and follows:

“The US model for GMP regulations is unique, and although specific for the manufacturing of dietary supplements, it is in reality a hybrid of food and pharmaceutical GMP’s. The dietary supplement regulations define the manufacturing and quality requirements for all supplements sold and distributed in the U.S. market. Identity testing on all incoming batches of raw materials is required, thereby assuring that companies are verifying that the raw materials purchased are truly the intended materials. According to FDA warning letters and other forms of communication, many firms are still not spending enough time developing appropriate test methods to validate the identity of incoming ingredients. To satisfy this GMP requirement, many companies use in-house verification technology, such as Fourier transform infrared (FTIR) spectroscopy and near infrared (NIR) spectrometers. These technologies are commonly used, as they are relatively inexpensive and quick, hence their appeal; however, they may not be appropriate for identifying all incoming materials, such as blends or botanicals."

None of us in industry knows what the outcome of the recent New York AG action will demonstrate, but a dialogue between the industry, from agricultural producer, to processor, to manufacturer and to retailer is long overdue, and should help all of us with a vested interest in protecting the consumer achieve a best-practices approach to risk management, while improving the confidence of all parties to this equation. The time for assuming others are doing the heavy lifting in raw material qualification procedures is officially over.

Mark A. LeDoux is founder, chairman and chief executive officer of Natural Alternatives International Inc., an organization with world renowned facilities in the United States and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients.

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