Written Nov 6th, 2014 by Franco Varriano
Making sense of FDA’s cGMP on Supplements
Today’s guest post is brought to you by Dr. Warren Brown, a naturopathic physician and former member of the Bastyr Center for Natural Health’s Formulary Review Committee.
In 2007, the U.S. Food and Drug Administration (FDA) issued a directive requiring that all dietary supplement manufacturers comply with Current Good Manufacturing Practices (cGMP) by June 2010. This directive, or “final rule” as it is called by the FDA, “ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.” So why did only two-thirds of the over-the-counter cholecalciferol products tested in a 2013 study fall between 90% and 120% of the dose listed on the label? (1)
Reason #1: Testing requirements are weak
The finished product testing requirements listed in the final rule are in some areas, weak and vague. These requirements focus more on the ingredients than on the finished product – this is a problem, since some ingredients are degraded as they move through the manufacturing process. Furthermore, the final rule doesn’t require that final products be tested by an independent laboratory, but rather relies on the manufacturer’s own personnel for approval. There is no mention of testing intervals either – a manufacturer could test at its own discretion, which could be once a year or even worse.
Dr. Vasilios Frankos, director of the Division of Dietary Supplement Programs at the Center for Food Safety at the FDA comments to manufacturers on cGMP:
“We’ve provided a very flexible framework for required testing. Other than a mandatory 100% ingredient identity test for incoming dietary ingredient, we have prescribed no specific testing program. Rather, we leave it to the firm to have a scientifically valid testing system where a mix of in-process testing and finished product testing will ensure that the dietary supplement meets specification and are not adulterated…you may exempt one or more product specifications from verification if you carefully document why.” (2)
“You must use adequate lab facilities to perform whatever testing or examinations are necessary to determine components used meet specifications, in-process specifications are met, and dietary supplements you manufacture meet specifications. These laboratory facilities can be your own or a contract laboratory.” (3)
Reason #2: Lack of enforcement
These directives typically aren’t actively enforced or monitored by the FDA, unless there have been concerns raised regarding public safety. It seems that the FDA is not willing to dedicate enough resources to more actively engage with the thousands of dietary supplement companies doing business in the U.S. today. Currently, the posture of the FDA seems to be no-harm-no-foul when it comes to application of cGMP.
What this means for your patients is that if they are taking over-the-counter supplements from the open market, they currently have about a two-thirds chance of getting their money’s worth.
What can you do to protect your patients? To start, when you prescribe products through Fullscript, you provide your patients with access to some of the world’s finest manufacturers, many of whom have a commitment to quality standards that surpass FDA’s cGMP – companies such as Vital Nutrients, Thorne Research, Integrative Therapeutics, and Metagenics (full disclosure: I have no financial relationships with any of these companies). Fullscript makes it easy for me to connect my patients with products from these manufacturers.
The fact that the FDA has addressed the issue of dietary supplement quality and safety is a good thing. Prior to 2007, there were similar product quality studies whose conclusions indicated that there was even less of a probability of capsule-label matching. (4) However, the FDA’s current cGMP standards still lack the bite needed to eliminate the riffraff manufacturers.
Dr. Warren Brown is a naturopathic physician and former member of the Bastyr Center for Natural Health’s Formulary Review Committee. His practice in Suwanee, Georgia focuses on sports medicine and men’s health.