IS OUR GOVERNMENT AN ENABLER?
As I have repeatedly cautioned, most of the advertised health-promoting “supplements” appearing in TV and other media are based on unfounded pseudoscience, imposing needless financial burdens and covert dangers to health. Although recognition of such fraudulent products is not always easy, certain tips can be useful: When one sees newspaper ads purporting to announce major health benefits (containing the word “advertisement” in small print) and followed by a statement ending with a disclaimer that includes “…not been evaluated by the Federal Drug Administration (FDA),” a red flag should be immediately hoisted! When TV ads claim certain health benefits (typically rather vague) in the absence of the usual listing of nasty side effects and dangers, it means this product has often not been subjected to the rigorous FDA testing standards, signifying that it is quite likely ineffective or dangerous (e.g. “brain enhancers” such as Prevagen, Neuriva, Cognilift, etc). The mere presence of a product on the shelves of standard pharmacies such as CVS or Walmart offers no reassurance, for, when I asked one of their representatives what criteria they used to offer a product for sale, she simply stated that sale-ability was the only measure. I was shocked to hear no consideration given for either safety or efficacy!
A recent article criticized the U.S. DSHEA (The Dietary Supplement Health And Education Act) [Sissung TM, et al. Are we healthier and better informed after 27 years? Lancet Oncology 22:915-916, 2021]. This article notes that since its passage in 1994, the supplement market has grown from an annual $4 billion industry with approximately 4,000 products to a $40 billion industry with an estimated 50,000–80,000 products used by between 40% and 60% of adults with or without chronic diseases. It concludes as follows:
The DSHEA has removed the burden of proof for good manufacturing, safety, and efficacy from supplement manufacturers while simultaneously providing a poor framework to monitor adverse events and prevent safety hazards. At the same time, it has facilitated a geometric increase in public expenditure on pseudoscientific therapies and has inflated public trust in misinformation. The DSHEA is even an obstacle to those who believe in complementary and alternative medicine remedies and expect that the products they purchase actually contain the ingredients listed on the packaging. If over-the-counter medications must meet clinical standards for safety and efficacy while showing good manufacturing practices and providing standardized labeling information to users, why should supplements that claim to have health benefits or reduce the risk of disease be exempted from such standards? Put simply, although it has been responsible for considerable economic activity, the DSHEA has promoted neither public health nor education for the past 27 years.
This summarizes an urgent need for the restructuring of the entire process of vetting and approving all health related products that include all supplements. Among the many potential improvements, all such products should be subjected to the same rigorous process required for drug approval by the FDA. In order to achieve this goal, the FDA should be provided with adequate resources and financial support. Until these goals are achieved, snake oil (AKA supplements) will remain alive and well, as I have described in my earlier book—similarly titled!