OWC Pharmaceutical Research Corp (OWCP)

[I-Glow]

I love statements such as:"There is absolutely 0 fact in this statement. This is yet another random thought presented as fact. Please do 3 minutes of DD, you'll find the answer."

But oddly, there is never any facts presented.

Here is what you are claiming isn't accurate. "but U are right in saying if they claim it for a specific medical use for skin disease or cancer they would need to be FDA cleared in that case right?"

It is absolutely correct that if the company is making claims of mitigating some dermatological problems - OWCP must have FDA approval.

I was researching a company that claimed they could "cure" a hangover - the FDA stated that a Hangover was a disease.

The FDA does indeed consider a hangover a disease! You are 100% wrong - the FDA clearly states that a hangover is a disease.

Its a physician-developed product that fights hangovers,.,,” is a disease claim is not based on the use of the verbs “cure” or “prevent,” but rather on the fact that product is being represented to be used to treat, cure, mitigate a disease, namely, hangovers.The agency considers alcohols intoxication, and its consequences, to be a disease.

http://www.fda.gov/ohrms/dockets/dockets/97s0163/97s-0163-let0831-vol25.pdf

Here is a letter from the FDA - let's go over it and see what we can find.

"FDA continues to believe that alcohol intoxication, like all poisonings (mushroom, digitalis, or any drug overdose), meets the definition of disease, albeit a transient disease."

"Beverage that helps cure and prevent hangovers.. . ” was a claim that did not meet the requirements of 21 U.S.C. 343(r)(6) but rather was a claim that suggested that this product.is intended for use as a drug within the meaning of 21 U.S.G. 321(g)(l)(B), and that it is subject to regulation under the drug provisions of the Act."

Then from the FDA Definitions we find: "(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals."

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm

If a company makes claims of curing or mitigating Psoriasis - they will need FDA approval.

IG