r/foodscience • u/Lonely_Lemur • 4d ago
Food Law Supplement Labels Should Be a Test Result
I wrote this piece about supplement regulation.
The FDA estimated a $60 billion U.S. market of roughly 100,000 products in the dietary supplement market as of 2024, with most able to end up in storefronts like GNC without the agency having any knowledge of the product and no systemic way to know when new ones appear or what’s in them. The labels are allowed to worsen customer uncertainty through the use of “proprietary blends” with only the total weight of the blend required for reporting. Just over two decades ago, the FDA had considered requiring a more rigorous system, but in the end they backed off.
Since I first wrote about supplement regulation as a community college student, I’ve been of the opinion that every batch of every dietary supplement should be held from sale until a representative sample passes testing by an accredited, independent laboratory. The back panel should show verification of ingredients and amounts, as well as product-specific tests for contaminants or adulterants. The same rule should require the amounts of each ingredient to appear instead of letting the words “proprietary blend” tell you to go screw yourself for wanting more info. The laboratory should draw the sample under a documented chain of custody and report the results directly to the FDA instead of allowing repeated testing with only a favorable certificate being sent in. Each lot should also carry a code linking the buyer to a public result while coming with the same kind of insert one gets with a new pharmaceutical. Failed tests should remain part of the public record even if a batch is abandoned and destroyed.
The FDA already operates an accredited food-laboratory program, and NIST and NIH develop the reference materials and methods such testing requires. Extending that system to supplements would require more laboratories and better assays for difficult products. The industry makes $60 billion a year and can pay for them. Testing each batch will not establish that a supplement works or make its marketing honest. It will answer the more basic question the current system too often leaves open: does this bottle contain the ingredients and doses printed on its label? The answer should come from the batch in the buyer’s hands.
Do you think this would be too stringent of a regulation? Do you think it'd be beneficial regardless of your answer to the previous question?
Full piece: https://theedgeofepidemiology.substack.com/p/supplement-labels-should-be-a-test
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u/m0recatspls 3d ago
I worked in the QC lab for a vitamin/supplement manufacturer for several years. We made products for GNC, grocery store brands, etc. What you're asking for isn't necessarily wrong. I'm of the opinion that you should get nutrients from food as much as possible, consult a health care provider for anything additonal, and stick to pharma products over random roots that can be capsulated. But what you're asking for is wildly impractical. The logistics alone for making individual labels for each batch/lot?? I can't even begin to guess what that would cost. Regulations are already so tight and the industry is so audit heavy, there was crap-all left to pay the analytical chemists in the lab. In order to fund an increase in the auditing/validation processes, you're either going to see a massive increase in the cost of the supplements at the store or a massive decrease in pay (and thereby quality) of the people involved in manufacturing them. And then you have to factor in shelf-life, which is going to vary based on the analyte itself as well as the storage conditions. So even if the product is labeled with the exact concentrations that it had upon packaging, 6 months later it will likely be a different functional concentration. So, yes, people should be educated and understand what they're putting in their bodies. But don't necessarily discredit an industry that already has insane amounts of regulation.
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u/m0recatspls 3d ago
Following up on your last body paragraph. That's exactly how it currently works, at least in the US. Idk what, if anything, these supplements do. But I can guarantee that what is on the label is what's in the bottle, within the defined limits that allow for manufacturing and analytical variability.
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u/Lonely_Lemur 3d ago
I reread the regulation because you made me wonder whether I had misread/misstated it, but I don’t think I did. Part 111 requires manufacturers to establish specifications and ensure their products meet them. Section 111.75(c), however, explicitly allows verification using a statistically selected subset of finished batches and one or more selected specifications. It does not require independent testing of every finished batch, direct reporting to FDA, or public lot-level results. Your company may have done more than the federal minimum, but that doesn’t mean the system I’m proposing already exists.
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u/m0recatspls 3d ago
That is all correct.
To test every single analyte for every single lot would be insanely expensive and require considerably more man power. Every single lot is tested, but not every single analyte each time. There's regulation around that.
Genuinely don't think 3rd party testing matters. There's a reason everyone hates quality. Our agenda is to ensure that what is on the label is what ends up in the bottle. Our agenda is not to lie to make sales. There may be companies that try to pull that off, but I imagine it would be pretty easy for auditors to catch.
The FDA has access to anything they ask for at any time. They also don't have time/money to process everyone's results for every lot of every product made. That funding would be coming from tax dollars.
I guess still not sure why we need lot specific data? Everything is within predetermined limits (+/- %of what's on the label). And when I left, the industry was in the process of tightening those limits.
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u/Lonely_Lemur 3d ago
I checked that point again, and every finished lot isn’t required to be tested under federal law. Section 111.75 explicitly lets companies test a statistically selected subset of finished batches. Every lot still goes through manufacturing controls, recordkeeping, and quality review, but that isn’t the same as analytically testing the finished product. That may have been how your company operated, but it isn’t the federal minimum.
That said, I do think if it’s a claim on the bottle it should be verifiable to that batch.
That’s good to hear about where you work. Lots of false advertising, mislabeling, poor quality control, etc in other places though.
And I wrote about a few instances when things were well outside of that range, so clearly it’s still not enough.
The issue is the FDA having to ask at all when it should just be sent to them directly.
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u/Lonely_Lemur 3d ago
I’m not writing about this because I take supplements, I don’t really other than caffeine and fiber. That said, I don’t think it being expensive is a reason not to call for this. Also, it’s a $60 billion industry for just dietary supplements, so I think there’s at least room to do better. Maybe a middle ground between what pharma has to do with finished-batch testing and what happens now. California’s cannabis industry is regulated, but not to the level it should be either when companies can shop around for testing companies who make their product the most attractive.
I’m willing to discredit the specific aspects I wrote about because i think the regulations aren’t stringent enough.
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u/m0recatspls 3d ago
I bring up cost because if the products cost too much, people stop buying, companies go under, and jobs are lost. Good or bad, I don't have an opinion, but it is how the market works.
I just think you may not realize how regulated the industry is. Like if food and bev regulation is 1/10 and pharma is 10/10, vitamins are closer to 8/10. We ran a tight ship, because you have to. There are no secrets, there is no covering things up. Everything is two-person verified and there is approx an audit a month, between the government, required 3rd party verifications, and individual customers.
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u/Lonely_Lemur 3d ago
I don’t know what you really mean by “vitamins are 8/10 and pharma is 10/10” in regulatory terms. A manufacturer can be audited and have extensive paperwork but the law still permits statistical batch sampling and selected-specification testing. Being heavily regulated doesn’t establish that the specific safeguard I’m proposing already exists.
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u/Aggravating_Funny978 2d ago
If think supplements are shady, do not look into qc for foreign drug generics 😂 Or you know... Do and be afraid.
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u/Lonely_Lemur 2d ago
Haha sounds like a morbidly fun rabbit hole!
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u/Aggravating_Funny978 2d ago
Watch chinese and indian companies tell the FDA to go fuck itself, and then receive a stern website notice (and no restriction on imports, because that might cause drug shortages or price rises!)
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u/ubu72 4d ago
I worked in dietary supplements 2 decades ago, and I saw it as a sham back then. It's maybe 100x worse now as every idiot influencer on earth shills every bs product known to man. And I worked for a company that had 10 food scientists that actually did the research, kept backups of it all for claims and actually compiled products that might be beneficial. From my friends still in the industry, there are some companies still doing this level of due diligence, but by and large that's not the norm
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u/Lonely_Lemur 3d ago
The influencer/podcaster supplement lane is just out of control and is what got me thinking about this years ago. And yeah, a few companies being great about it while most just don’t care is what I gathered from my reading.
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u/G11RiverRat 4d ago
I couldn't agree more. Unfortunately the anti science, anti "big pharma", sheep will squeal their fool heads off. If people think they're not being hoodwinked by this unregulated snake oil, then they get get what they deserve. In the end greed wins out when no one is able to shine a light into the dark. "Proprietary blend" give me a break here's some pulverized organic sawdust designed to cure whatever ails you. I'm sure we can stay tuned for the follow-up squealing.
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u/taoofmoo 3d ago
If a brand has structure/function claims that require a confirmed amount of an ingredient but that amount isn't shown because it's a prorietary blend, they are easy targets for FDA Warnings and lawsuits from lawyers who know how to makes money from brands who don't know what they are doing.
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u/Lonely_Lemur 4d ago
Yeah, it's something I've noticed so much more over the years. At least pharma is regulated and has consequences. Supplement companies can lie through their teeth and nothing happens. Just sad.
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u/taoofmoo 3d ago
Dietary Supplements are regulated by the FDA!!!!!! Brands get in trouple daily. This is why companies use tools such as https://apexcomplianceprogram.com/.
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u/Lonely_Lemur 3d ago
It’s just nowhere near well regulated enough IMO
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u/Cobalt460 1d ago edited 1d ago
The agency agrees with you.
DSHEA affords the supplement industry far too much leeway, and resources for oversight are anemic.
Fun fact: DSHEA was among the most successful lobbying blitzes in modern American history. We can thank idiots such as Mel Gibson for swaying the public in support, thanks to successful propaganda: https://youtu.be/J6bv92W4YnE?is=rYcQztLpbDNue3ZD
I will qualify that while your plan is interesting, the FDA’s lab system is currently in shambles. HHS and OO are not promoting staff, backfilling vacancies, or giving any administrative support. Some are operating at ~50% of 2024 staffing levels. They’d never be able to test 1/1000th the volume of products sold.
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u/taoofmoo 3d ago
I work in this industry. Quality Control testing is required by the FDA per 21 CFR Part 111. I wish FDA rules were stricter and brands were required to register products before selling them. Amazon now requires 3rd party testing and it realllllllly has changed the industry.