re: Help needed with LSU research survey questionnaire (organics foods etc)

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o...what's the right answer for the FDA questions?

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Registration of firms (with FDA) who make drugs is required by Federal Law (by the Pure Food and Drug Act) Registration of cosmetics manufacturers is not mandated by federal law - it is purely the decision of the manufacturer (voluntary) and almost none register.


Within limits, FDA inspects all drug manufacturers (+- every 2 years), if they place their product into interstate commerce. The FDA inspects for compliance with Title 21 CFR (Drug Good Manufacturing Practice) The FDA has the authority to force compliance or removal of product from market. They will tell you "A drug is a drug". However some facilities are inspected more often than others. What they refuse to discuss is (IMO) that the frequency of inspections is scheduled on a "Risk Based Analysis of the level of products produced".

GMP regulations and requirements for drug products are strict and most drugs are safe and effective - or their recall is demanded by FDA and or federal charges filed against company management - and people have gone to jail for failure to comply with the Pure Food and Drug Act, or GMP.

IMO - Most recalls you hear about are based on a manufacturers belief that the FDA is just about to file a Warning Letter, Injunction, or criminal charges. At that point, companies usually voluntarily recall their adultered product, which is what the FDA calls any product that fails to comply with GMP.

I'd be happy to answer drug compliance questions based on my 40+ years in the business.


Food products fall under FDA control (Per the Pure Food and Drug Act) However the FDA has little to do with food safety, farming most of that out to ASDA. Some plants (for example - all meat packers who ship their product in Interstate Commerce) have a USDA inspector on site at all times.


If you produce food or drugs or cosmetics and never place them into interstate commerce, you are never inspected for anything other than (Maybe, but probably not) a local Health Dept. inspector or (even Less Likely), your state pharmacy board.


I think the correct answer is Food and Cosmetics = no FDA involvement - compliance responsibility falls back to manufacturer. Drugs - (both OTC and ethical drugs) yes, regulated by FDA.


A funny story - The company I worked for before retirement (I was VP of Quality) produced both cosmetics and drugs. The FDA inspectors refused to enter the cosmetic production areas of the plant. If they were looking at a record and realized it was related to a cosmetic product, they put it down and walked away. To be fair to the FDA, they would need to at least double their staff and budget to pick up regulatory compliance control for cosmetics - there are Many-Many more cosmetic manufacturers and cosmetic products than drug products. The raw materials are usually different and the effect on bodily function by cosmetics (Safety) is not well known by industry or the scientific community.

enough bla-bla-bla from me.