BACKGROUND: A BAD, BAD LAW
One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense.
(political content removed), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM,
(political content removed). It should be noted that ____ happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.
Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
In other words, when a supplement is marketed it’s more or less the honor system. No registration with the FDA is required. After all, supplements are food, not medicine! In effect, the government can’t really do anything unless problems are reported after the supplement is marketed. Even worse, the definition of “supplement” has become very broad, as Quackwatch points out:
DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
In other words, under the DSHEA, substances that are clearly not foods can be marketed as supplements, including herbs and other botanicals (the vast majority of which are marketed as having a beneficial medicinal effect and some of which contain chemicals that do act as drugs). As long as the manufacturer is careful not to make specific health claims, it’s all good. In other words, a “nutritional support” statement claimed for a supplement must not be a “drug” claim; i.e., it must not claim that the supplement can be used for the treatment or prevention of a disease. Supplement manufacturers easily evade this requirement by making vaguer claims related to organs or systems, such as claiming that a product “boosts the immune system,” “supports heart health,” or something similar, often accompanied by what Dr. Lipson has sarcastically referred to as the “quack Miranda warning“:
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
