There are a lot of bogus claims in health care. Even many drugs that are FDA approved seem to oversell their effectiveness and under-report their side effects. There are limits to the health claims product manufacturers are allowed to make, however. Drug makers and dietary supplement manufacturers are required to back up health claims or face the wrath of the Federal Trade Commission (FTC).
For decades, the FTC has required companies to back any medical claims about their products with substantial evidence, while taking actions against hundreds of “bogus health cures,” said Jessica Rich, the FTC’s director of consumer protection from 2013 to 2017.
The requirement to substantiate health claims could possibly change if a supplement maker wins a lawsuit, according to Kaiser Family Foundation (KFF) Health News:
Don’t get Nathan Jones started on xylitol, the active ingredient in his chewing gum, nasal spray, and other products. He’ll talk your ear off about its wondrous powers against tooth decay, as well as its potential to fight covid, heart disease, Alzheimer’s — you name it.
For now, Jones, the founder of Xlear, can’t make those claims in his company’s advertising. But if the lawsuit his company brought against the Federal Trade Commission succeeds, he’ll likely be able to say anything he wants.
If successful, the lawsuit by Jones’ company “would be a complete game changer,” said Mary Engle, associate director of the FTC’s advertising practices division from 2001 to 2020.
Xylitol sweeteners are a better alternative for chewing gum than those made from sugar due to dental cavity prevention. Basically, acid producing bacteria cannot metabolize xylitol and therefore it does not produce acid to erode tooth enamel. However, Nathan Jones cannot say that directly on the package. But what about the veritable plethora of other health claims other dietary supplement products allude to? That is where the lawsuits gets worrisome.
The Alliance for Natural Health joined Xlear in a separate petition in May demanding that the FTC drop its requirement for companies to provide substantial evidence backing health claims, and to withdraw 2022 guidelines that generally require companies to run a randomized clinical trial to prove their claims.
The way it currently works is word gets out and becomes general knowledge within the community of people who take dietary supplements. For instance, it is well known that bacteria cannot metabolize xylitol. People can author books discussing appropriate uses for a generic substance. They can post health claims on websites and send out newsletters if such claims are not directly tied to a product. Yet, the makers of specific products cannot claim health benefits without substantiating them.
Another reason health claims become problematic is because if dietary supplements do what their manufacturers claim they might be considered an unapproved drug. For instance, red yeast rice was banned by the FDA because it is chemically identical to lovastatin, an approved cholesterol drug. Drugs must go through a strict approval process, which began with the Food, Drug & Cosmetic Act (FD&C Act). If a company were to prove their herbal supplement lowers cholesterol or reduces blood pressure, the FDA could expect the manufacturers to go through rigorous clinical trials for safety and efficacy:
The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].
One way the FDA gets products of dubious merit off the market is through bogus claims. For example, there are numerous electromagnetic stimulation devices on the market for a range of legitimate uses. These include ones used to stimulate damaged nerves in feet, called peripheral neuropathy. But can electromagnetic stimulation cure cancer? No, but that did not keep some purveyors from claiming it could. The FDA subsequently banned one infamous machine that made such claims. There is no evidence that Papimi devices kill cancer cells, but it can knock out a television remote, an iPhone and probably a pacemaker in half a second. A few alternative medicine chiropractors still use them.
The FDA is rigid and the drug approval process both costly and difficult to navigate. Many people prefer to treat themselves with dietary supplements. Yet, there also needs to be safeguards against snake oil salesmen making bogus health claims without proof they work. While research finds the placebo effect is real, I would prefer products claiming to cure whatever ails me have evidence behind them than just the placebo effect. It is a delicate balance and perhaps the current system is the best we can hope for.
KFF Health News: FTC Has Long Said Products Must Back Up Health Claims. A MAHA Lawsuit Would Upend That.