Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

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.



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.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: