What's in Your Supplement (Part II)?

When someone looks at the nutritional label on a food product, they probably do so with the assumption that the labeling is, at a minimum, accurate and truthful. After all, these are regulated by the government and the labeling standards are enforced by the FDA, right? Well, in the case of nutritional supplements, yes and no.

The authority of the FDA to regulate supplements is defined in the 1994 Dietary Supplement Health and Education Act. You may be shocked to discover that one of the groups exerting significant influence over the content of this law was.... get ready for it .... the dietary supplement industry! As a result, and contrary to what the title of the Act may lead you to believe, the law severely dilutes and restricts the authority of the FDA to regulate supplements. One major difference is that while a drug must be proven to be safe and effective to the FDA's satisfaction before it can be released onto the market, a dietary supplement is presumed safe based on the manufacturer's word, need not be proven effective for any purpose and needs no approval before it can be marketed and sold to the public. There are no requirements to register the supplement product with any regulatory agency. Manufacturers are expected to comply with Current Good Manufacturing Practices (CGMP) standards and are required to report to the FDA any "serious adverse event" reported to them and associated with the use of the supplement.

As for the accuracy of the product labeling, manufacturers "must make sure that product label information is truthful and not misleading". Let's see how they are doing with that.

Back in 2010 I examined the manufacturing mistake that put 1,000 times the intended dose of Vitamin D in Gary Null's Ultimate Power Meal, powering Gary Null and several of his customers to severe kidney damage. Since that time, the situation has apparently not improved much.

In a 2013 study reported in the Journal of the American Medical Association Internal Medicine, Kaiser Permanente scientists, as part of a separate study, tested the potency of vitamin D pills.  They found that only 1/3 of the pills fell within 10% of the stated dose. An expanded study revealed a variance in actual potency of between 23% and 146% of the dose stated on the labeling. In a followup study to that, vitamin D-3 supplements were tested from 12 different suppliers and found to vary from the stated does in a range of 9% to 146%. There were large variations even within the same manufacturing lot number.

According to the independent consumer testing organization Consumer Lab, nearly 1/3 of vitamin supplement products (all of them, not just vitamin D) fail to meet standards for quality and labeling accuracy.

Supplement products have been found to contain glass particles, fecal material from rodents and insects and adulterated levels of pharmaceutical products. (None of these were listed on the label.)

This is not an argument to stop supplementing. But unless you are comfortable taking the manufacturers word for it, you are well advised to check with independent testing services such as Consumer Lab and Consumers Union to verify what you are taking. And check out the company behind the pills.