Are Current Good Manufacturing Practices and FDA Inspections a Guarantee of Therapeutic Quality?

Nutritional and herbal supplements to the functional medicine practitioner are analogous to the surgical instruments of the surgeon. Without these indispensable tools, little can be done to correct or alter an inevitable path toward system pathologies. Therefore, providing quality supplements is of the utmost importance for the patient in order to achieve safe and effective treatment results.

You would think every practitioner would be providing quality supplements for their patients
and, indeed, most believe they are, but you would be wrong. Practitioners rely on industry
standards such as the current Good Manufacturing Practices (cGMP). The purpose of these
recommended guidelines is to confirm the identity, purity, strength, and composition of
ingredients, and to ensure they are free of contamination. Documentation is required at each
stage of testing, and manufacturers are subject to unannounced FDA inspections. However,
cGMP is a principle-based framework providing recommendations for quality standards. This
provides a false sense of confidence because it does not guarantee the biological or therapeutic
effectiveness of nutritional and herbal supplements.

The next higher standard is the International Organization for Standardization (ISO) adopted by some manufacturers. ISO is a standard-based framework with established specifications and requirements, not just recommendations. There are some supplement manufacturers that have an ISO certified laboratory facility that implements these standards for their nutrients, which is why their nutritional supplements consistently test well in my clinical practice. This quality standard is much more reliable, but it is still not a guarantee that a nutritional or herbal supplement will be of high therapeutic value.

The concern—and the point of this post—is how, throughout my 27 years of clinical practice, I have often experienced frustration with numerous good quality nutritional and herbal supplement lines that were suddenly altered in some manner which ruined the therapeutic value.

Sometimes this occurs due to the original manufacturer making changes in production or substituting with inferior ingredients that technically pass the purity test. However, significant declines in therapeutic quality are assured when companies that manufacture exceptional supplements are acquired by larger manufacturers and/or venture capitalists. New operation managers always seem to tinker with original manufacturing processes and raw materials sourcing to be more profitable, but they do not understand or care how their alterations can diminish the therapeutic value of the original processes.

Just recently, a prominent herbal company whose extracts I have been using in my practice for many years was recently taken over by a larger herbal contract manufacturer. It was sudden and without any previous warning. This manufacturer advertises 30 years of experience using artisanal methods hundreds of years old and is cGMP compliant and FDA inspected. I was assured by the new representatives that the company would be implementing the same processing procedures. But as it turned out, this was not the case.

For 6 months the milk thistle seed extract was out-of-stock, which is the equivalent of a Chinese food restaurant running out of rice. When I finally received the new product, it was a different formulation. This new extract had a 75 – 85% alcohol content, higher than the original 55 – 65% alcohol content I used for years. Initially, I did not believe it would be an issue knowing extracts of milk thistle seed require a high alcohol content. I was actually expecting a superior product. However, I was disappointed and very concerned to find it tested poorly against my original product test samples, and would not be suitable for my patient nutritional protocols.

When I called to complain, the representative told me I was sent the wrong milk thistle extract, claiming they were trying something new. Would you buy that explanation? I shipped it back. Guess where that inferior milk thistle extract is going to wind up? Back on the market for someone else. I asked her to send me samples of the new product to test before shipping my order to avoid the immense hassle of returning a large quantity of liquid extracts. When I received the samples of the new “original” formulation, I was stunned to find it tested even more poorly than the other! Guess what they are going to do with all of that milk thistle extract?

At this point I felt it was necessary to speak to the production manager. When I called, I was transferred to the director of operations. He tried to assure me that it was made at the same facility and processed in the same manner. I asked if I could speak with the herbal formulator of the original company, to which was followed with a long pause, and then, “Well, we work with a team.” Uh huh. So, there you have it. It is not the same herbal formulator or process, but it is all cGMP compliant and FDA inspected.

This was then followed by an event with a patient who had been using a bottle of a different herbal extract from their new production. It resulted in causing her severe low back pain because it did not provide the same therapeutic support for her kidneys. Keep in mind, this is not an isolated occurrence. It is representative of the general nutritional and herbal quality the public purchases from health food stores, grocery stores, online discount brands, and even some doctor lines. In my view, in terms of therapeutic quality, cGMP recommendations amount to a good-enough-for-government-work standard by which these large-scale manufacturers are allowed undeserved high standing within the supplement industry. It has become the equivalent of USDA Organic. What does that mean exactly? Not as much as you would think. That is why it is important to incorporate higher standards of therapeutic testing through an experienced kinesiologist who specializes in testing nutritional and herbal supplements, because you may not be getting what you think.