Despite the possibility that some dietary supplements could have real health benefits, there are many reasons to be skeptical of the safety and value of most supplements on the market. Most have not been tested scientifically to an extent that marketing claims made about them are truly legitimate. Unfortunately the legal framework for regulating these products almost guarantees that most never will be adequately tested. Thanks to the politicking that has led to the Dietary Supplement Health and Education Act (DSHEA), this “travesty of a mockery of a sham” masquerading as public health regulation makes it possible for the multibillion dollar industry that is Big Supplement to profit from selling supplements without ever having to prove they do what the companies claims, so long as the claims are sufficiently vague and the Quack Miranda Warning is appended I small print at the bottom of the page. As a consequence, the supplement industry can make a sizeable sum of money without having to turn around and invest much of that in research or quality control.
The supplement industry is known to spend a far smaller share of its profits on research that the larger, and much more closely watched, pharmaceutical industry, since the law requires little evidence of safety and efficacy for its products. However, even DSHEA requires some minimal quality control standards for herbal remedies and dietary supplements as well as placing some limits on the marketing claims that can be made. The GAO has previously reported that, despite this, contamination with dangerous substances and illegal marketing practices are common in the herbal medicine industry.
And now FDA inspection reports have shown that the dietary supplement industry also has serious and widespread problems with quality control, safety, and regulatory compliance.
The Chicago Tribune has published an article detailing the failings of the supplement industry to meet even its minimal obligations under DSHEA. Here are some examples:
- The FDA has found violations in nearly half of the 450 firms it has inspected.
- 1 in 4 supplement companies have been issued a formal warning letter for violations, a significant enforcement action under the limitations placed on FDA by DSHEA.
- Violations of good manufacturing practices were found in nearly two-thirds of 204 inspections conducted this year alone.
- About 1 in 4 products the company tests have a significant problem, said Tod Cooperman, president of ConsumerLab.com. Some contain significantly less of an ingredient than is promised on the label, some far more. Sometimes the product contains contaminants, like lead. Some are rancid. Some have the correct ingredients but are “bedpan bullets” — incorrectly formulated pills that won’t break up in the body.
There is a huge body of evidence showing that inadequately tested supplements and an insufficiently regulated supplement industry can not only fail to help but can actively harm people (see below). And the limited evidence from the veterinary field is certainly no better than that for the human supplement market.
There is a dangerous double standard that requires chemicals called drugs to be extensively and expensively tested (which isn’t always sufficient to prevent harm even with great efforts) and yet chemicals called “herbs” or “supplements” can essentially avoid any testing of safety or efficacy. Even attempts to require basic accuracy in labeling, quality control in manufacturing, or honesty in advertising are routinely ignored by this industry. Without more serious efforts to control the supplement companies, people will continue to waste their money, and even sometimes damage their health, by using these unproven and uncontrolled products.
Some of the Harm Caused by Vitamins, Supplements, and Herbal Remedies
Vitamin C can interfere with chemotherapy.
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Widespread Failures in Quality Control of Dietary Supplements Herbal Preparations, Including Ayurvedic and Traditional Chinese Medicine (TCM) Herbs:
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