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Comment by seiji | Hacker News Reader

Aren't supplements/non-medical powders/various other juju immune from FDA issues?

They don't need to be approved in the typical FDA sense, but the ingredients do need to be considered GRAS (Generally Recognized as Safe).[1]

GRAS just tells people what they're allowed to sell, but most food products have been around long enough they are grandfathered in. The bigger issue that the FDA still mandates, is that the products are prepared under cGMP standards. The standards are open, available, and not at all onerous if you intend to be an honest business.[2]

Essentially, you need to have trained staff, clean buildings, batch records, clean equipment, known ingredients (no allergens accidentally introduced), etc. Really basic stuff. Unfortunately, it's mostly self-policed until an 'incident' at which case the FDA can do an audit and raise hell.

[1] - http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/

[2] - http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinf...

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.

- FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

http://www.fda.gov/food/dietarysupplements/

From the QA link: They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

So, Soylent is probably considered a food since it is a sole item of a meal.

Ah, got it. So it's just self policing until you kill someone, then the regulators step in.

There are a few dietary supplements that voluntarily submit to FDA inspection of their facilities. Most don't. The protein powder I use is one of them:

http://www.1stphorm.com/products/men/level-1

I wouldn't really consider using anything that isn't, but lots of people do every day, probably mostly from ignorance.

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