We are going backwards. Hopefully this will be temporary trend, but it has been consistent for the past few decades. Prior to the FDA we had the “wild west” of patent medicines – anyone could put anything in a bottle and sell it with any claims. It was up to the average person to decide if a product was safe or effective. As you might imagine, this lead to an industry of snake oil that exploited the public while providing little benefit. The creation of the FDA in the US changed the picture, putting an end to most (not all – homeopathic products being a notable exception) of the abuse by requiring evidence of safety and efficacy prior to marketing any drug, and regulating what claims could be made for them.
The snake oil industry was never happy with this regulation, they wanted the freedom to essentially lie to the public, make hyped unsupported claims, and sell products with dubious benefits. But they persisted on the margins, and in 1994 their lobbying paid off with the Dietary Supplement Health and Education Act (DSHEA). Prior to DSHEA any product that claimed to treat or cure any disease was, by regulatory definition, a drug and had to prove safety and efficacy prior to market. But DSHEA created a new category of claims, so-called “structure function” claims, which are a massive loophole for the snake oil (I’m sorry, I mean supplement) industry.
With such claims you just have to be a little careful with your wording. A supplement cannot treat dementia, but it can support cognitive health. The supplement industry exploded with all kinds of products making all kinds of claims, some adhering carefully to the structure-function regulation but many not. We entered a new era of snake oil.
This also had the consequence of funding a massive and growing “wellness” industry, which has benefited from social media as well. Supplements sold with dubious structure function claims now supports a multi-billion dollar industry that promotes anti-vaccine conspiracy theories, many unscientific health claims, science denial, and further anti-regulation efforts. We may be seeing the peak of this movement with MAHA which is essentially in power at the federal level.
We are now seeing yet another snake oil craze with injectable peptides (which we have covered before). Peptides are strings of amino acids, the building blocks of proteins. They are not technically proteins until they fold up into a specific configuration – prior to folding they are just peptides. There are many legitimate injectable peptides on the market, the first being insulin in 1923. All of the GLP-1 drugs on the market for diabetes and obesity are also injectable peptides. These are FDA-approved drugs.
So why are there now so many injectable peptides that can be sold without FDA approval? Good question. These are potentially powerful agents that have to be injected (usually subcutaneously), so why aren’t they considered drugs? Part of the reason is that they are not chemicals, they are technically biologics. They are not supplements so they are not sold that way. They can, however, be purified and packaged by compounding pharmacies, so they are regulated that way.
Compounding pharmacies have lists of drugs they can compound (the 503A bulks list) and ones they cannot. There are three regulatory categories – category 1 substances were submitted to the FDA for review with adequate information and do not fit into any other category. Category 2 are considered by the FDA to be too risky for compounding pharmacies. Category 3 were submitted with insufficient evidence. Here is a more detailed description of all relevant federal regulations.
The Biden administration added 20 popular injectable peptides to the Category 2 list, essentially banning them from compounding pharmacies. This did not eliminate the market, but did create a “gray” market for these products. Now the Trump administration, under RFK Jr (who is a fan of peptides due to his personal use) is reviewing 7 of these peptides for inclusion in the approved lists, with 5 more to be reviewed next year. Kennedy is pushing hard for their approval, so there is no mystery what is going to happen.
But make not mistake – these injectable peptides are snake oil. This doesn’t mean that they cannot or do not have any benefit, it means we simply do not know and the claims made for them are not adequately supported by high quality evidence. Here is a typical wellness site promotion:
“Peptides have quietly become the new MVPs in the world of functional medicine and anti-aging therapy. These naturally occurring compounds — tiny chains of amino acids — work like messengers, telling your body to heal, regenerate, and perform at its best.
Used in injection form, peptides can support everything from faster muscle recovery to improved metabolism, hormone balance, and even smoother, firmer skin.”
Notice the use of the term “support” – that is a structure function claim, designed to comply with DSHEA. That means they do not require any evidence to make such claims.
The most popular injectable wellness peptide is likely BPC-157, which is claimed to promote healing and recovery. A recent systematic review of research into this compound finds a single clinical trial, with only 12 subjects in an open-label design, looking at knee pain. That is a pilot study at best, absolutely useless for determining efficacy.
Loosening FDA regulations as a gift to wellness influencers and snake oil peddlers will virtually guarantee that no rigorous clinical studies will be done. There is no incentive to do such trials. We may see some in house studies used to support marketing. Because there is a legitimate orthopedic and sports medicine question here, we may see some serious investigator-initiated research, but without the resources to do the large clinical trials that are really necessary.
This is why allowing such products to be sold without proper evidence is a lose-lose proposition. If the product is not safe or effective, then the public is being put at risk and are being cheated out of their money and resources for a useless product. If it does work, we may never know, and it will therefore be impossible to incorporate its use into science-based practice. Whether it works or not, everyone is better off (well, other than the snake-oil peddlers) if we confidently know through rigorous clinical trials.
Kennedy will not always have control of federal health care policy, but it remains to be seen what comes after him. Promoting the snake oil industry has been a bipartisan activity. But there will be an opportunity for more science-based regulation and perhaps the pendulum can swing back again in the direction of the consumer.
