Seasoned chemists and bloggers Randy Schueller and Perry Romanowski of The Beauty Brains recently discussed the proposed federal Personal Care Products Act in their recent podcast and we asked them to clarify the current regulation of the beauty industry and where it is headed.
For years there have been claims that the beauty industry is not government regulated, but you and Perry say this is false. Are cosmetic and personal care products regulated and how much? Why do people have this misconception?
Randy: The idea that the cosmetic industry is unregulated is a myth. In fact, there are 3 levels of regulation to which the industry is subjected:
Here is a run down of how those levels function.
The Food, Drug & Cosmetic Act
- Prohibits “poisonous or deleterious substances”
- Restricts particular ingredients
- Mandates claim substantiation
- Regulates color additives
- Requires warning label for coal tar based hair dyes
Important point that causes confusion: The FDC act does NOT require companies must test their products for safety prior to marketing. If the FDA determines that the safety of a product has NOT been substantiated, the product is misbranded (illegal).
What can the FDA do?
- Prosecution – Criminal charge against the company.
- Seizure – Federal marshals takes possession of all products.
- Injunction – Civil action that requires you stop making and distributing the product.
- Recall – Companies have to pull products off the shelf.
The Fair Packaging and Labeling Act mandates that labels must include the following: product identity, net contents (also includes provisions against under-filling), name and location of manufacturer, list of ingredients, warning statements when needed. The FDA’s Over the Counter Drug review is another way the FDA has jurisdiction over cosmetics, at least for cosmetic-drugs.
Additional oversight laws
- Toxic Substances Control Act
- Under the jurisdiction of the EPA
- Controls single ingredients, not finished products.
There is no direct authority over cosmetics but if the EPA rules that an ingredient is dangerous, you can expect the FDA will look at it as well and likely consider it to cause the product to be adulterated and therefore it would fall under their jurisdiction under the FDC act. The Federal Trade Commission regulates advertising. They prohibit “unfair or deceptive acts or practices affecting commerce” which is broad. The NAD is a second source of advertising regulation They are more likely to challenge cosmetic ads but they don’t really have any authority to take action. Instead what they do is turn the issue over to the FTC. The Consumer Product Safety Commission (CPSC) has authority over soap, hazards presented by cosmetic containers - glass packaging which is breakable, or packages with small parts that could endanger children, and special packaging standards under the Poison Control Act (e.g. child proof caps).
In addition to these federal controls, states are free to pass whatever laws related to cosmetics that they want as long as their laws don’t conflict with federal mandates.
Every state has regulations that apply to soap and cosmetics. Most of them follow the FDA regulations pretty closely, but some have more extensive requirements. For example:
- California pioneered legislation which restricts VOCs is determined.
- Florida requires a “cosmetic manufacturer permit” for any person that manufactures or repackages cosmetics in Florida.
- Maryland outlawed specific phthalates in cosmetics.
Self-regulation of cosmetics
Finally, on top of all these federal and state restrictions, the cosmetic industry polices itself through the following voluntary registration programs:
- Registration of manufacturing facilities
- Registration of cosmetic raw material composition and ingredient statements
- Filing of adverse product experiences
These all help the government get access to information it needs to ensure safety.
If the Personal Care Act passes, what impact do you think this will have on the market? For example, do you think companies will reformulate their products or change their manufacturing practices in order to make them more appealing to ingredient-savvy consumers?
Randy: If ingredients are found to be unsafe cosmetic manufacturers will be prohibited from using them. If that's the case they will have to reformulate their products. Of course that's no different than how the industry is run today. It's unlikely that this regulation would have any impact on their manufacturing processes. As we said in our podcast it's likely that companies will pass on any additional regulatory costs to consumers.
Why do you think this could stifle innovation?
Randy: If these regulations create additional red tape that slows down the approval of new ingredients or formulas it will be more difficult, time-consuming, and expensive for companies to bring truly new products to the market. Those extra hurdles could inhibit innovation from some companies.