Supplement Wildly Unreliable, Despite FDA Regulations

Image: Wikipedia Commons
Image: Wikipedia Commons

Lots of people have an opinion on supplements. But when you go to the store to buy one, you’d expect the amount of the active ingredient to be consistent, right? Apparently, that doesn’t seem to be happening.


Scientists tested one supplement which is sometimes used to treat high cholesterol called “red yeast rice.” They bought lots of the supplement from GNCs, Walgreens, and other stores, and analyzed the amount of monacolin K, the beneficial chemical, in the pills. It turned out that the amount of monacolin K in the same-sized pills varied wildly. All of this comes after the US Food and Drug Administration’s 2007 supplement production regulations.

Study author Pieter Cohen from Harvard University asked Gizmodo: “After implementing the revised standards, how could it be that the most mainstream products sold at retail pharmacies and grocery stores aren’t standardized?”

Yes, red yeast rice is ancient Chinese medicine, and Gizmodo coverage is generally hostile towards supplements. Before you write this one off, though, red yeast rice’s monacolin K is the same ingredient in the cholesterol-lowering drug, lovastatin. But according to the National Institutes of Health, “The U.S. Food and Drug Administration (FDA) has determined that red yeast rice products that contain more than trace amounts of monacolin K are unapproved new drugs and cannot be sold legally as dietary supplements.” So folks are buying it to lower their cholesterol, but the FDA says there can’t be more than a trace amount of that cholesterol-lowering chemical in the product.

All that goes out the window with a little testing, however. Of the 28 brands that Cohen’s team tested, 26 had monacolin K. The amount could range anywhere from .09 to 5.48 milligrams per 1200mg red yeast rice pill. Six of the tested brands contained more than the 4 milligrams maximum allowed by the FDA.

“Consumers would have no idea which were and weren’t the ones with more than the allowed monacolin K amount,” said Cohen.

So, what’s going on? Probably, companies aren’t being compliant and the FDA isn’t enforcing the law, said Cohen, but more likely it’s the former—companies are just importing big vats of rice powder without checking which part of the plant goes into their pill.


There are limitations to the study, Cohen (and the paper, published today in the European Journal of Preventive Cardiology) pointed out. The team only analyzed single batches from each brand, and the amount of the chemical might change between batches.

But that doesn’t change the fact that relying on red yeast rice for monacolin K could be dangerous, especially when it shouldn’t have any of the chemical in the first place. On top of that, monacolin K has side effects like muscle pain that folks taking a supplement might suffer unsuspectingly.


At least one source thought this was a case as to why we shouldn’t deregulate the pharmaceutical industry. “We don’t have to speculate what a deregulated pharmaceutical industry would look like,” Arthur Caplan, New York University bioethicist told Gizmodo. “We just have to look at the supplement industry.” Caplan doesn’t blame the FDA in this case. “I think they’re doing their best to nose their way into the oversight of supplements, but there’s a ton of resistance.”

We reached out to the FDA about the results, but they do not comment on individual research, and are reviewing the paper’s findings. The spokesperson did offer some general information on supplement regulation via email:

FDA regulation of dietary supplement safety is generally post-market, unlike with drugs and devices where it is generally pre-market. Put another way, most drugs and devices cannot be marketed until they have been affirmatively shown to be safe. On the other hand, like conventional foods, dietary supplements may be marketed without FDA approval. In general, a lack of safety information does not prevent a dietary supplement from being introduced to the market.


Furthermore, “Red yeast rice products containing added lovastatin, or manufactured to contain enhanced levels of lovastatin, cannot be marketed as dietary supplement,” and “The FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of dietary supplements to the Department of Health and Human Services’ Safety Reporting Portal.”

So really all that can be said here is that you shouldn’t trust a supplement to do the things that a prescribed pharmaceutical should be doing, especially if the supplement contains the same active ingredient as the prescribed pharmaceutical.


Said Cohen: “This is exactly why I do not recommend my patients use red yeast rice to lower cholesterol.”

[European Journal of Preventive Cardiology]


Former Gizmodo physics writer and founder of Birdmodo, now a science communicator specializing in quantum computing and birds


Why hasn’t someone yet sold a supplement called “Plahseebow”? Our product solves pretty much whatever ails you. Maybe. It seems like it’d be about as reasonable. Better yet, it might even be legal as the placebo effect is real even if you know a product is a placebo.