I know the FDA isn’t the stuff of excitement and intrigue. But it’s stuff you gotta know, because when they decide they’re going to enforce, they come down with an iron fist. Would it help you to know that histories of bribes and scandals abound there? Yes, there’s some serious passion beneath all that analysis of foodstuffs! OK, really, it’s because it’s possibly the most understaffed agency in US government and the corruption is nothing more than survival, but let’s just pretend it’s because there’s something steamier than hog manure going on beneath their government-issue desks.
((image by cottergarage on flickr))
Something to keep in mind: the FDA applies to whatever you decide to sell over state lines. What you sell within the state, however, is between you and your state legislature. Some states are so strict in their food and cosmetics regulations that they make the FDA look like a cute little agricultural think tank by comparison. So what you get from state to state will vary in the way it is monitored.
The requirements of the Food, Drug, and Cosmetic act are pretty simple, really: you can’t sell it if there’s something wrong with it, and you had better tell people what’s really in there.
The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition–whether they result from ingredients, contaminants, processing, packaging, or shipping and handling–cause cosmetics to be adulterated and subject to regulatory action. Under the FD&C Act, a cosmetic is adulterated if–
- it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual [with an exception made for hair dyes];
- it consists in whole or in part of any filthy putrid, or decomposed substance;
- it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
- its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
except for hair dyes,- it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)
Sounds complex, doesn’t it? It’s not.
- it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” [with an exception made for hair dyes]
If it will injure the user, you don’t get to bottle it up and sell it. Except for hair dyes - some injury is considered par for the course with that stuff. - it consists in whole or in part of any filthy putrid, or decomposed substance;
- it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
- its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health
The packaging should not endanger the user, either. - it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)
Buyers like pretty colors but adding some pretty colors to cosmetic products are poisonous. The FDA has a specific list of what those particular dyes and additives are.
If it’s rotten, rancid, moldy, or otherwise gross, you’re not allowed to sell it for people to rub on their faces.
While this isn’t requiring lab conditions necessarily, you are expected to make stuff so it’s actually clean by somebody else’s standards.
