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0 pointspeterwwillis12y ago0 comments

They've got to be violating some kind of FDA rules.

Like what?

http://en.wikipedia.org/wiki/Food_and_Drug_Administration#Fo...

http://en.wikipedia.org/wiki/Regulation_of_food_and_dietary_...

"The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products."

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382512y ago

You can't make blanket statements like "Soylent is perfectly balanced and optimized for your body and lifestyle, meaning it automatically puts you at an optimal weight, makes you feel full, and improves your focus and cognition." because people might think they can eat Soylent and nothing else. I won't say they are breaking the law. All I am saying is they need a lot of clinical trial to cover their butts in court.

peterwwillisOP12y ago

False. There is no law that requires them to qualify "structure or function claims". They can claim it makes you 200 feet tall, and it doesn't matter, because it is not a drug and it has nothing to do with listing ingredients on the label.

However, false advertising claims are handled by the FTC. I suggest you talk to them before the FDA.

edit: For a court case to be effective the plaintiff has to prove that the product does not work; the burden of proof is not on the manufacturer, according to FDA regulations. Depending on wording this could require a long testing period with many people for a judge to take it seriously.

refurb12y ago

Incorrect!

General Mills got the smack down from the FDA for claiming that Cheerios lowered your cholesterol. [1]

[1]http://www.fda.gov/iceci/enforcementactions/warningletters/u...

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

breadbox12y ago

It's true, though -- under current law, you get a free pass for the majority of evidential requirements just by calling your product a "supplement". As long as they don't explicitly state that it can cure something specific (see e.g. Airborne, which made that mistake), the above wording you quoted isn't much different from the junk you see all over labels in health food stores.

Kuiper12y ago

>people might think they can eat Soylent and nothing else.

Isn't that the intent? Rob Rhinehart (creator) lived for a period of one month eating Soylent and nothing else. My understanding is that Soylent is intended to be a meal replacement, not a supplement of some kind.

soulashell12y ago

He's still eating Soylent, and has been consuming it for now 4 months I think.

1 more reply

nkohari12y ago

IANAL, but at a minimum, it's likely they should include the standard supplement disclaimer of "This product is not intended to cure, prevent, or treat any disease" [1]. This protects them from liability depending on how the FDA decides to classify the product.

Regardless of legality, they are making some very bold claims that would benefit from some scientific study. Preferably, expert, peer-reviewed, published scientific study.

[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRs...

joering212y ago

Why would Y-combinator alumni have to comply with any government imposed rules? I hate to sound like a broken record but check my comments or history of PG companies he founded. AirBnB co-founders were or still are on FBI top spammer list that used tax money to spam people to high heaven.

As of the product, I join vast majority that says stay away. My personal thing is that after reading one of their interview where they were inviting people to clinical study, I send them long detailed email covering my willingness to participate and even pay all the cost from my own pocket. My email got ignored and I never got response. For that reason alone, I would stay away from something you have to pay for, because their customer support sucks from the get go.

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