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Cosmetic Regulations  •   California Dreaming / States  •   Organic Cosmetics

Cosmetic Regulations

 
   
   
The regulations for cosmetics are issued under authority of the FD&C Act and the FP&L Act and are codified at 21 CFR 700. Consult our FDA regulatory consultant for a clear understanding. This is what we do, day in and day out.

What's different now?
We have a new administration in Washington along with a new Commissioner at the FDA. Expect a more aggressive approach to compliance regarding cosmetic regulations.

Cosmetic Labeling
We are challenged with these twin issues:
  • Is the claim a drug claim or cosmetic claim?
  • Are the claims substantiated?
Hard hitting claims continue to be critical to marketers, but expect more activity from the FDA - especially on the drug vs. cosmetic front.

Advertising
No doubt the FTC (Federal Trade Commission) as well as the smaller FTC agencies in the States will be more active in pursuing claims, which on the surface, appear to be unsubstantiable. We recommend that you have this data before the ads are placed.

California Dreaming / States

  California flag - FDA regulatory consultant
   
   
California is certainly the most active state in passing legislation that directly impacts cosmetics and over-the-counter (OTC) drugs.

Marketers whose names appear on labels absolutely have to be aware of Proposition 65 and how to avoid the legal and PR problems this law is now causing companies.

Bounty hunters are more sophisticated in knowing what products to target on the basis of reviewing the ingredient list. Many commonly used ingredients are known to be contaminated with listed chemicals such as ethylene oxide, 1,4 dioxane, lead, formaldehyde, nitrosamines and others. It turns out the "safe harbor" levels are not as safe as the law envisioned. We can help you with this regulation.

We are now dealing with the California Safe Cosmetics Act which is a similar piece of legislation with onerous reporting responsibilities for hundreds of the cosmetic companies selling in the state.

The Green Chemistry Initiative is now taking shape, which promises more of the same.

The VOC ( Volatile Organic Compounds) standards of the Air Resources Board (CARB) for many product categories have become very familiar to us and these standards must be observed.

Organic Cosmetics

  organic personal case - fda regulatory consultant
   
   
The organic personal care field has been in disarray for some years as to standards, and this is not good for our industry long term. There have been competing private standards and there obviously has been confusion.

Recently we've seen progress toward a rational and national standard and this is creating a level playing field. Please refer the OASIS website for more information. Call us, we can provide guidance regarding organic personal care regulations.

For information on Canadian regulations, click here.

Cosmetic regulations l Organic personal care
For excellent info. on cosmetic safety, check out www.CosmeticsInfo.org.
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