Most of us want to do what we can to remain healthy. We’ve become convinced that dietary supplements can help, which has resulted in Americans mainstreaming supplements. The dietary supplement industry is happily taking advantage. The reality is that many supplements deliver little to no health benefits, despite what their makers would like you to believe, including dietary supplements for hearing and tinnitus.
Nearly three-fourths of U.S. adults, about 144 million, report taking dietary supplements. More than half report as regular users [1]. U.S. dietary supplement industry revenue is reported to range from about $50 to $60 billion. Although the U.S. population is only about 4% of world population, Americans account for roughly 30% of estimated global dietary supplement revenue of about $200 billion.
Even as supplement usage increases, consumers have become increasingly wary of nutritional supplements and skeptical about their claims, and for good reason. The dietary supplement industry continues facing numerous and well-founded allegations of deception as it has become increasingly common for some makers to misrepresent their products.
A supplement maker includes a tiny amount of a safe ingredient, whether or not that ingredient has been demonstrated to be effective and markets the formula as a “powerful solution” to a health problem. It is not possible for the product to deliver the claimed health benefit. The maker is deceiving consumers and often getting away with it.
The problem is dietary supplement regulation.
The root of the problem is the federal law that governs the dietary supplement industry; specifically, the provision for industry self-regulation contained in the 1994 amendment to the Federal Food, Drug, and Cosmetic Act of 1938, the Dietary Supplement Health and Education Act of 1994, Public Law 103-417, enacted by the 103rd U.S. Congress, called DSHEA. Under DSHEA law, the FDA issues dietary supplement industry guidelines, but the law allows the supplement industry to largely regulate itself.
Dietary supplements that do not contain a new food ingredient and comply with DSHEA law do not need FDA approval before they are sold to consumers.
The FDA's authority includes removing products that pose an immediate safety concern or an unacceptable risk of injury or illness. The Federal Trade Commission is responsible for enforcement of dietary supplement industry advertising [2].
“In general, FDA is limited to postmarket enforcement because, unlike drugs that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to approve dietary supplements for safety before they reach the consumer.” [3] [emphasis added]
Since 1994, when the law governing FDA oversight of dietary supplements was last updated, the industry has grown 20-fold and has shown no signs of stopping. Meanwhile, federal oversight has not kept pace, despite some positive steps forward, including FDA's creation of the online Dietary Supplement Ingredient Advisory List in 2019 [ibid 3].
The weaknesses in DSHEA law have been noted and discussed for decades [4]. The Dietary Supplement Listing Act of 2022 would have legislated more stringent dietary supplement industry regulatory oversight [5]. It failed to pass.
“...users overestimate the federal government’s regulation of these products. The truth is that although the Food and Drug Administration oversees supplements, it does not review or test their safety before they are sold. The agency has no way of knowing for certain what supplements are on the market, nor what they contain. In addition, FDA cannot mandate recalls for supplements that may be tainted with illegal pharmaceuticals. These glaring deficiencies have hurt, and continue to hurt, the Americans who take these products [6]. [emphasis added]
The SCOGS database is the dietary supplement industry's shopping cart
The FDA operates the Select Committee on GRAS Substances (SCOGS), an external panel of experts [7]. GRAS substances are dietary ingredients determined to be Generally Regarded as Safe for human consumption.
The GRAS substances in the SCOGS database are classified by the level of scientific understanding. Dietary supplement makers can basically make whatever they think consumers will purchase if they stick with ingredients in categories 1 and 2 in the table below. Including ingredients from categories 3, 4, and 5 requires FDA application processes to defend new research, typically a steep hill to climb for all but the largest dietary supplement makers.
Consumers pay the price. Tinnitus cure is an example.
By DSHEA law, dietary supplement makers are not allowed to claim dietary supplements prevent, cure, diagnose or treat any disease, and their products must say that on their labels. However, it’s plain to see that prohibition doesn’t stop some makers from violating the law to extract money from consumers.
Tinnitus supplements are an example close to home. It is easy to find dietary supplement products advertising they cure tinnitus, despite significant scientific agreement that tinnitus is an incurable neurological disorder. It is also easy to find information saying none work.
The FDA and the FTC issue warning letters to violators [8][9], but to our knowledge, the FTC has not issued warning letters to any dietary supplement makers claiming their products cure tinnitus.
References
- 2023 report from the Council for Responsible Nutrition (CRN) Consumer Survey on Dietary Supplements, the dietary supplement industry trade association and lobbying group. https://www.crnusa.org/newsroom/three-quarters-americans-take-dietary-supplements-most-users-agree-they-are-essential
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Example: Starr RR. Too little, too late: ineffective regulation of dietary supplements in the United States. Am J Public Health. 2015 Mar;105(3):478-85. https://pmc.ncbi.nlm.nih.gov/articles/PMC4330859/pdf/AJPH.2014.302348.pdf
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https://www.congress.gov/bill/117th-congress/senate-bill/4090
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Stronger Federal Oversight of Dietary Supplements Will Protect Consumers From Unsafe Products, https://www.pewtrusts.org/en/research-and-analysis/articles/2023/01/26/stronger-federal-oversight-of-dietary-supplements-will-protect-consumers-from-unsafe-products
- https://www.fda.gov/food/generally-recognized-safe-gras/gras-substances-scogs-database
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https://consumer.ftc.gov/consumer-alerts/2019/02/ftc-fda-issue-warning-letters-supplement-sellers
