There is an article in the upcoming issue of Consumer Reports discussing the sorry state of regulatory oversight for dietary supplements, herbs, and vitamins, and some of the concrete harm that has come to consumers as a result. It is encouraging to see the mainstream media recognizing that the marketing of such supplements is full of misinformation and that there is real danger in the inadequate regulatory system currently in place.
According to the industry publication Nutrition Business Journal, Big Supplement sold $26.7 billion worth of its products last year. However, according to the relatively neutral, though perhaps sometimes a bit too charitable in its interpretation of the evidence, Natural Medicines Comprehensive Database, only about a third of the 54,000 products in the database have any scientific evidence concerning safety and efficacy. And nearly 12% (over 6000 “medicines”) have known problems with safety or quality control. This is a pointed reminder that when talking about supplements, we are not talking about natural products proven to be safe and effective and provided out of altruistic motives to people not well served by the conventional “disease industry.” We are talking about products containing chemicals with poorly understood effects on the body and products which may or may not contain what the label claims is in them. And we are also talking about large profit-making corporations capable of manipulating politicians and the law to avoid appropriate regulation of their industry and both willing and financially able to vigorously defend themselves in court against people hurt by their products.
The Consumer Reports article points out that contamination of supposedly natural supplements with toxins, such as heavy metals, and with prescription drugs, is a serious danger due to the exemption of the supplement industry from the quality control regulations the FDA applies to pharmaceutical companies and other providers of medicines and healthcare products. Many of the most harmful products and ingredients come from China, which has abysmal quality control and is not in any way under the supervision of any trustworthy regulatory or watchdog organization.
The article also gives several examples of specific products that have harmed consumers, and the complete denial of responsibility on the part of manufacturers. The notion that these companies and their products differ from the mainstream pharmaceutical industry, beyond being less effectively supervised and regulated, is belied by these kinds of problems. Even the regulations that do exist concerning such products are rarely enforced, and vigorously opposed by the supplement industry. When the FDA attempted to ban ephedra, it took years of legal maneuvering despite thousands of cases of suspected illness and death from the ingredient. This has discourage the FDA from attempting to invoke it’s regulatory authority, especially in the anti-regulation atmosphere of the last administration.
And unlike Big Pharma, for most of the time since the relevant legislation (DSHEA) was passed in 1994, Big Supplement companies haven’t even been required to report serious adverse events associated with their products to the FDA. And the reports that now come in are rarely made public. So it’s not surprising that consumers, and many health care providers, have little idea how dangerous these products can be. Of course, mainstream pharmaceuticals have their dangers, but at least we have some idea what they are and some reason to think they may have benefits which justify the risks.
The article lists an even dozen supplements to be specifically avoided due to known hazards. It also lists a number it considers safe and likely effective. I would quibble a bit with these lists. The “bad” list is a bit arbitrary and incomplete, and it ignores the danger of the nearly complete ignorance concerning the safety and efficacy of most supplements. And the “good” list includes a couple of products (e.g. glucosamine and St. John’s Wort) which are listed as “likely effective” despite pretty clear evidence they are ineffective. But these are relatively minor objections given the vital importance of having a mainstream consumer group address the serious problems in the supplement industry and advocating for better consumer protection.
Not surprisingly, Big Supplement rejects the conclusions and advice in the article, cherry picking facts to present a misleading image of the industry as benevolent providers of safe products. Their rebuttal, weak as it is, is further undercut by the presence on the same page of a banner reading “Grassroots Victory: Congress rejects expanded FTC powers.” Clearly, despite their own propaganda, Big Supplement is as interested in protecting their prerogatives and profits as Big Pharma or any other for-profit industry. This is to be expected. What is harder to understand is why we continue to let them guard the henhouse.