Should the FDA classify dietary supplements as drugs?
- The FDA says that dietary supplements include vitamins, minerals, herbs, amino acids, and enzymes.
- According to ConsumerLab.com, the most popular supplements in the US in 2020 were vitamin D, magnesium, and fish oil.
- Dr. Casimir Funk is considered to be the “godfather of the vitamin movement,” after having conceived of “vital amines” in 1912, which were “essential nutrients with a specific action, requiring only minute amounts with the power to cure a specific disease.”
- The FDA defines drugs as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Unlike prescription drugs, dietary supplements go to market without safety, quality, or purity testing from the FDA; however, they are not entirely free from regulation. Supplement manufacturers must notify the FDA before marketing any new products, and the agency can recall supplements for various reasons. Additionally, it's in the manufacturer's best interest to sell a safe product, as lawsuits are frequently filed against supplement companies and corporations such as Amazon. Any supplement maker who wants to make money and not get sued will tend to self-regulate their products.
Supplements are big business with a global market estimated at $129 billion for 2021. It's no surprise that the FDA wants a hand in that money pile, but their regulation isn't necessarily a safety marker for consumers. The FDA collects fees from drug manufacturers to approve their products (one 2016 application fee was $2 million for a single drug). But while the FDA is boosting their budget, they're not necessarily making drugs any safer. About half of the US population takes an unregulated supplement per day, with an estimated 23,000 per year ending up in the ER because of it. A similar number take FDA-regulated prescription drugs, and there are 2.7 million adverse reactions recorded yearly.
Meanwhile, low-income populations may benefit the most from supplement usage, as poor households tend to correlate with poor dietary choices. Therefore, supplements addressing dietary deficiency, such as folic acid and vitamin C, are crucial for overall health in these circumstances. Increasing supplement regulation would restrict access and disproportionately harm low-income people who are already likely under-insured because FDA regulation costs would be passed onto the consumer.
Reclassifying dietary supplements as drugs is unnecessary and prohibitive.
While dietary supplements do technically have some FDA oversight, the current legal framework contains significant loopholes that allow manufacturers to sell products without administration approval or even pre-testing. This creates a market that is ripe for snake oil salesmen and opaque, or even tainted, ingredients.
Without a testing requirement, it is difficult to determine if a given product will actually produce the claimed results or if there will be any potential side effects. For comparison, look to your average ad for Viagra or anti-depressants, which always feature a long list of warnings--because all those tests have already been completed. Currently, the only way to determine if a supplement has any adverse effects is after it's been on the market.
Unregulated supplements allow room for bad actors to move into the space. At best, this could mean customers are sold simple placebos that don't perform any actual function. At worst, customers could be substituting inappropriate supplements for effective medication, actively harming their health.
This doesn't mean the FDA necessarily has to regulate supplements as prescription-only drugs. The organization oversees plenty of over-the-counter medication as well, and it's likely many supplements would remain OTC even under stricter FDA oversight. But this sort of regulation can provide a universal framework, requiring manufacturers to hit specific targets before selling anything.
Finally, even if many supplements do end up being prescribed, the primary advantage is doctors having a more complete understanding of their ingredients. By knowing exactly what's in them, doctors will know what is and isn't safe when interacting with other drugs, lessening the possibility of a dangerous reaction.