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Unapproved Pharmaceutical Ingredients Included in Dietary Supplements (jamanetwork.com)
67 points by scott_s 4 days ago | hide | past | web | favorite | 63 comments





The FDA needs to regulate supplements. At the very least they need more random spot checking and stiff fines for misrepresenting ingredients.

It's absurd that you can't trust that the ingredients list on something as mundane as a multi vitamin is accurate.


The FDA is prohibited by law from regulating "dietary supplements", much of that thanks to Orin Hatch. A concerted campaign (largely effective) stripped the FDA's ability to regulate many forms of snake oil, "alternative medicine", and other quackery.

What do you mean prohibited from regulation?

The reason why we know these supplements have unapproved pharmaceuticals in them is because regulations say: 1) you can't, 2) the FDA has the power to test them, 3) the FDA has the power to force a recall.

The FDA is prohibited from banning supplements that have been in use prior to 1996 (or so). They are also allowed to restrict what can be said about the supplements (they can't make unsupported medical claims).

I don't know about you, but unless a supplement is actually dangerous, I think it's good the FDA can't come in and tell adults what they can and can't put in their own bodies.


The FDA is prohibited from requiring safety and efficacy evidence before supplements go on the market. This is unlike substances categorized as drugs, which require both safety and efficacy evidence before going on the market. So the FDA won't know if a supplement is actually dangerous until after it is on the market, and then it will have to find that particular supplement among the thousands that exist, as the onus is on the FDA to find and prove it is dangerous.

That’s not accurate. You can’t just create a new chemical and call it a supplement. There has to be pre-existing data indicating that a supplement has been used in the past (prior to the legislation).

If data suggests a supplement isn’t safe, the FDA can ban it.

Plus, you’re not allowed to make specific safety or efficacy claims when selling a supplement. You can be vague about “It’s been used for insomnia”. But that’s about it.


Yes, you can. You have to submit safety information, but you're not barred from entering the market. From an article about a supplement that was essentially an unregulated drug because it was an unknown drug:

> Under a 1994 federal law, supplement makers must submit some kind of safety data to the F.D.A. if they plan to introduce new ingredients to the market. And manufacturing-practice rules require them to make sure their products contain only the ingredients listed on the labels, with no hidden substances. But, unlike drug makers, supplement makers are not required to prove that their products are safe and effective on humans. Nor do they have to get federal approval before selling their products. That means it is up to the F.D.A. to identify any risky supplements from among the estimated 85,000 on the market, and to prove that they are adulterated or present health hazards.

https://www.nytimes.com/2013/03/17/business/a-soldiers-paren...

Again, the onus is on the FDA to find supplements that are previously unknown, regulated drugs. If we flipped the requirements, supplement makers would be barred from selling their supplements without clearing them with the FDA first. The active drug in that story has since been banned by the FDA: https://www.fda.gov/food/dietarysupplements/productsingredie...

You're not allowed to make specific medical claims. But you are also not required to show any efficacy for what you do claim, and the supplement industry regularly gets as close as they can to "specific medial claim." And sometimes they cross it! And, again, the onus is on the FDA to find such cases.


We are in agreement then. My statement “you can’t just create a new supplement” was in reference to the claim they don’t need safety information. They do, either new data (for a new molecule) or existing data (for a supplement with known activity).

In terms of the onus being on the FDA, that’s how it should be. A default “it’s banned unless we say so” would limit access to supplements that have been used for decades. They’d need to be pulled off the market. Supplement makers are unlikely to have access to the millions of dollars it would take to a supplement through clinical trials to prove safety and efficacy.

And as for the claims, the FDA issues warning letter by the ton when supplement makers step over the bounds.


We're in agreement on the facts, but not apparently on what we want to do about them. I have no problem that this would take most supplements off the market, as I think the current system makes companies exploiting consumers very likely.

Even an inert supplement is dangerous if its marketing and labeling leads uninformed people to believe it's a substitute for an actual working pharmaceutical.

The FDA already prohibits efficacy claims on supplements.

You can claim it’s used, but t can claim it treats any disease.


Snake oil is so 1900's. Now it's fish, coconut and other types of oil.

There is a certain sense fish oil is snake oil (because they're marketed as something they're not) but evidence suggests fish oil supplements do have some health benefits to humans. [1]

>High doses of omega-3s can reduce levels of triglycerides.. Omega-3 supplements may help relieve symptoms of rheumatoid arthritis.

My understanding is that there is no evidence suggesting fish oil is beneficial for humans other than these two things. However, regularly eating fish has a few more benefits. So, instead of taking fish oil pills, it probably makes more sense to eat fish once a week.

[1]: https://nccih.nih.gov/health/omega3/introduction.htm


A recent trial showed unexpectedly good benefits of fish oil pills https://www.xconomy.com/new-york/2018/09/24/amarin-soars-as-...

Agreed. I have been studying fish oil and coconut oil at great length recently due to affects it had when I was trying to repair gut issues. Many websites give the positive effects of the omega-3's and the MCT's from Cocnut oil, but leave out important facts such as fish oil being a blood thinner and anticoagulant. This can prevent wounds from healing and even causing significantly greater damage.

In my opinion, people should start with topical treatments for arthritis first, such as blue-emu or penetrex cream, as it is safer (not entirely safe, but much safer) than ingesting anything that is a COX-1 or COX-2 inhibitor, or that acts as a blood thinner. I mention Cox-1/2 because many other supplements are in that category (Curcummin, Aloe and many others) but people may not understand what that can mean for them. A lot of folks take Aloe for Arthritis, but not everyone should. It depends heavily on your gut lining and health.

I am reaching a point where I can probably debunk most of the health websites and I might make some youtube videos on the topic, since many of these sites are harming people by not giving them all the facts. NIH being the number one offender. For some time, I thought those articles were vetted and peer reviewed. A few of them are, but most are not. Anyone can publish write-ups on PubMed it turns out.



Don't forget to thank Mel Gibson!

https://www.youtube.com/watch?v=FLGNm8_y6yU


The real villain here is Orrin Hatch (R-Utah): http://www.latimes.com/business/hiltzik/la-fi-hiltzik-hatch-...

Strangely enough, his Wikipedia article doesn't mention his championship of the natural health industry, the word "supplement" doesn't show up even once. It must be that even his supporters find the "Dietary Supplement Health and Education Act of 1994", which he sponsored, too blatantly in favour of the industry and too damaging to public health.


As other people have noted, there is a symbiotic relationship between Orrin Hatch and the supplements industry. https://www.nytimes.com/2011/06/21/us/politics/21hatch.html Many of the companies involved in supplements manufacture are based in Utah, and many of the MLM companies involved in supplement distribution are based in Utah, most of the employees would be Mormon and the companies would be Mormon owned just based on probability so there is a captive audience of two Senators and four House members ready to defend the Wild West of supplements in the USA, Senators being able to influence bills to a much greater extent, given that Utah would probably never elect a Democrat to office it's going to take something like a 60-40 Democratic majority in the US Senate for this to ever change.

The article calls out sexual performance and muscle building supplements (many of which are snake oil).

The word vitamin doesn't appear in the article.


Which has zero bearing on the parent's point: supplements (which includes vitamins) aren't regulated making them less safe.

There's an incentive to adulterate these products with anything producing noticable positive short-term effects. There's no reason to believe vitamins are exceptional here - if you start taking a multivitamin that seems to improve your focus and energy slightly, you're more likely to continue buying that vitamin. A small addition of Amphetamine salts or even caffeine would do the trick.


Could the market solve this problem better than the goverment? https://labdoor.com. What's missing now is enough people to negatively review products on Amazon and the like. Perhaps that could be automated.

Most folks buying supplements aren't in a position to perform checks on the ingredients in the actual pills. Not only that, but they aren't always in the position to know which claims are BS and which aren't. It is wonderful that such companies exist, but most folks won't check. And if someone simply doesn't check a product, it'll go undetected. And all it takes for a product to start flying off shelves is someone like Dr Oz mentioning the product and folks deciding he simply wouldn't give bad information. They trust him more than random website.

(I should mention that I worked in a pharmacy, and have seen these effects first hand. I've also seen folks completely ignore a pharmacist recommendations for whatever their cousin's husband's mother said).

I'll add that I wouldn't trust such an agency to tell me my actual, FDA-approved medications are safe, and we are basically talking about folks using products for health reasons.


I check labdoor every time I'll get something relevant (protein powder, chocolate, multivitamin) as a psychological reference, but I can't find any convincing evidence why labdoor should be more reliable and correct than the labels on the products. Do they publish their methodologies? Also for some product types all products fail California heavy metal regulations, and they just give everyone 0 points, instead of publishing exact amount of heavy metal in products. Like, I wanna know if I'm gonna get mercury poisoning if I eat two servings, or is it just above the threshold and should be safe...

Positive reviews on Amazon can also be automated. There's a whole industry of gaming reviews.

Caveat emptor is never going to work for subtle problems like this.


Is that exactly what the FDA is doing here? Spot checking and enacting penalties for violations.

Note that the paper used the FDA's own wesbite for it's analysis.


Here is the data that the study is compiled from. The majority of the added compounds are sildenafil (Viagra) or analogs of it. Interesting to me, Locacerin showed up in some of the weight loss preparations.

https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?...


Thanks for posting the list. This is a list of dick and diet pills and Slim Fast. Slim Fast is genuinely surprising to see on this list, especially considering it's for an ingredient they used to have openly but was banned. The rest of this stuff is not at all in the same category as whey, creatine etc., and the study muddies the waters by grouping them together.

It seems like these products are mysteriously tainted with illegal active ingredients that make them functional. It is unclear to anyone why or how this would happen.

Legal or not, they're filling a real niche with real demand. If you have ED and insurance, you can go to the doctor, who will run tests to confirm that you have a medical need before prescribing you Viagra/Cialis/whatever. If you're uninsured, or are actually capable of getting a boner on your own, but just want a performance boost so you can have marathon sex or crazy orgies or something, the guy at the gas station has your back.

What sort of test does a dr perform to see if you need Viagra? I thought the doc just asked some questions and wrote the prescription if you gave the right answers?

Because the company wants their supplement to be more effective to encourage sales is the likely answer.

Looks like your browser isn't correctly displaying the sarcasm font.

At least it's not irrelevant drugs, like I first thought when I read the headline. Like Vitamin C that works like, I dunno, sleeping pills, for example.

The reality of supplements is that there is a limited number that are both safe and have strong scientific evidence backing them. Whey protein, vitamin D, ZMA, caffeine maybe a few others. If you buy those from any kind of reputable brand (Optimum Nutrition is a great place to start), there is absolutely zero risk of any of this happening. If you start taking sketchy pre-workout that boasts ridiculous improvements, then yeah you will end up getting a mixed bag of stuff. But the idea that this is hard to avoid is nonsense. Same with athletes who test positive and then blame a supplement. This problem is not at all difficult to avoid, you only find trouble if you're looking for it.

Forgive me if I'm reading your take wrong, but I believe your general attitude is buyer beware. That is, you're assuming there are bad actors out there, and the onus is on individuals to avoid those bad actors.

My take is that it's unreasonable to expect most of the population to be mostly skeptical of the products they consume most of the time. I think most people have the feeling that things they buy at the drug store or GNC will not actively harm them; I don't think they understand that the supplement industry is essentially unregulated. I think they have about the same level of trust in supplements as they do in, say, buying meat from the grocery store. My position, then, is rather than acceding to the existence of the bad actors, we should use regulation to prevent them from existing.

An editorial from a medical researcher who thinks the FDA is under-performing in even the light regulation they have of the supplement industry: https://jamanetwork.com/journals/jamanetworkopen/fullarticle...


No that is not my attitude. My attitude is that the only people who are experiencing issues are shopping way outside of normal channels. Nothing you buy at GNC will be tainted with steroids.

The study takes 150 random products and finds issues with 20% of them, I guarantee those 20% are not sold at GNC, VitaminShoppe etc.

This is just really not a big problem for normal every day people.


You are correct that most of the supplements in this study are not sold at retail, as explained in the article:

> Since FDA sampling has focused on dietary supplements found online or through import screenings, this data analysis does not indicate the prevalence of these adulterated supplements at retail locations.

But I would not have confidence in what is sold at retail. A 2015 operation by NY state found problems with supplements sold by GNC, Target, Walgreens and Walmart: https://well.blogs.nytimes.com/2015/02/03/new-york-attorney-... Granted, I don't think they found any actual drugs in the supplements, but many of the supplements did not contain what they claimed to contain, and some of what they did contain are potential allergens.


Every day people probably buy more vitamins by volume at supermarkets and drug stores. But I see no reason to believe any distributor is safer across all products sold.

http://time.com/3741142/gnc-vitamin-shoppe-supplements/


Look at the names of the "supplements" they found issues with:

https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?...

Literally the only surprising one on the list is Slim Fast, and it's so surprising I'm wondering if they are using extremely old stock or something. The rest of the "supplements" are dick pills with names like "Sexy Monkey."

It's just not even the same market as the weekend warrior crossfit bro who takes whey protein and maybe gasp creatine.


I buy whey protein at the grocery store, and I'm comfortable doing so because it makes no promises other than being something I can use to get some easy calories and protein. But places like GNC have lots more than just protein and creatine under "Muscle builders", "Performance Formulas", "Cleansing & Detox" and "Appetite Control". I consider those to be the same market as a bunch of the stuff on this list.

Testing for tainting with pharmaceuticals is no doubt going to find it mostly in weight loss and sex pills. Heavy metals you'll find in the herbs. Proteins would probably be more contaminated with animal/food related issues like in canning.

The general problem is that whatever you look at you are likely to find a type of contamination that isn't being checked for with the same level of oversight as the food industry or the pharmaceutical industry.


Slim Fast is not on the list.

It's crap, but it's not on the list.


https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?...

It is on the list, and now that I look closer, yes the stock they are using is from 2009 when Slim Fast openly advertised that they used sibutramine. They have since stopped, so this list is somewhat suspect.


Sorry, I was referring to the well-known USA SlimFast retail product from SlimFast, owned by Kainos Capital (formerly Unilever).

The "Slim Fast" that is on this FDA list is a knock-off from "Universal ABC Beauty Supply International, Inc."


Ah, I owe you an apology then. I was super confused when I saw it on the list, and found a bunch of stuff related to Slim Fast and sibutramine but I guess I didn't read it close enough. Thanks for the clarification.

No problem. I missed that it was a multiple page list in the first place and missed the "Slim Fast" name altogether.

> Nothing you buy at GNC will be tainted with steroids.

Didn't GNC sell Superdrol and other designer steroids and pro-hormones?


Let all the people who rely on non-approved drugs just die, lose their minds, or go to prison. They're pathetic fucking illegal-drug using peasants, anyway, amirite.

So why aren't these companies being shut down and their executives arrested for drug trafficking? As an individual this is exactly what would happen if say your St. John's wort also contained some prescription drug that you did not have a prescription for and the authorities found out. Somehow it's ok for companies to peddle this garbage to millions but not ok for the individual?

There was an NHL player who recently got suspended that made this argument. I wonder if that was actually the case. Certainly, this evidence would help his case or at least cast reasonable doubt.

Many UFC Fighters have also made the claim, and were apparently vindicated by testing at least twice I can recall.

This is the free market at work, throwing off its chains. /s

Are you saying that if there wasn't a free market there wouldn't be fake products?

That's obviously false.


The free market proscribes fraud.

In the most abstract way possible: sure, in the real world: not so much.

Misrepresenting your product is fraud and is illegal in a free market.

Misrepresentation is commonplace, even outright fraud is commonplace. Serious fraud is a multi-billion dollar industry. "Light fraud" and gray area misrepresentation is at least hundreds of billions of dollars a year.

It's still illegal under a free market, and prosecutable.

The "free market" doesn't make fraud or misrepresentation illegal, the laws and regulations of the dreaded government do.

The worst the free market can do to a fraudster is to stop dealing with her as knowledge of her frauds becomes widely known. That, of course, doesn't work very well to limit fraud.


Only if you get caught.

That's like saying "murder is proscribed only if you get caught".

Why do people buy that stuff? They could choose not to.

Well... we're generally used to "adulterants" referring to inactive or even potentially (purely) harmful ingredients being added to things to make them cheaper. However, note that "adulterating" your sexual potency supplement with Viagra means that it will, you know... work. Same with putting steroids in your workout supplement... it makes it work, better than the competition that doesn't do it.

There are all kinds of other problems with that, of course. I'm not saying it's a good idea. But in terms of "why would people buy these?", well, I'd suggest part of the reason is that people want to lose weight, be sexually potent, or get swole, and these "adulterated" supplements actually work. Just at a cost you may not have realized you were paying, or intended to pay.




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