Donald Trump, our president-elect, colors his hair and use make-up to touch up his allegedly tanning- bed-colored skin. His daughter, Ivanka has her own line of perfume and make-up.
Will the chronically understaffed cosmetic office of the Food and Drug Administration become even more of a paper tiger without teeth? Will it be able to fix the omissions in the current regulations?
Many legislators have tried to strengthen the FDA’s shortcomings: Senator Dianne Feinstein (D-CA) and Susan Collins (R-ME) are the latest. They introduced The Personal Care Product Act S.1014 to the Senate April 20,2015.
Their bill amends the current Federal Food, Drug, and Cosmetic Act to require cosmetics companies to register their facilities and the ingredients they employ with the FDA.
Personal Care Has Secrets
Can you believe it is currently voluntary for cosmetic companies to register and to not be required to report their ingredients?
Thus, you may mix a cosmetic compound in your kitchen or garage, make claims about its effectiveness and sell it.
The law does not require cosmetic products and ingredients– other than color additives- to have FDA approval before they go on the market. http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm
Under the S-1014 bill, cosmetic companies must pay a facility registration fee based upon their annual gross sales. The collected fees can only be used for cosmetic safety activities.
Right now, the FDA cannot force a cosmetic product’s recall. Under the proposed S-1014 legislation, if the FDA determines a cosmetic has a reasonable probability of causing serious adverse health consequences, it may prohibit the cosmetic’s distribution from the facility’s registration.
Labeling is also a big problem
Angela Diesch, affiliated with the Sacramento, Washington law firm, Kronick Moskovitz Tiedman & Girard, specializes in regulatory and business services for suits over marketing claims such as “Organic”, “Natural,” and “Unscented.
Diesch says “there is no formalized legal standard for these claims for cosmetics. She says some companies have defended their use of “natural” by pointing to information contained on their own websites.
President-elect Trump, of course, is very familiar with lawsuits but as Chief Executive will he be prepared for the new deluge of actions against cosmetic companies?
Johnson & Johnson has been served with more than 2000 lawsuits from women who claim they or a loved one developed ovarian cancer from talcum powder. The women argue that “Johnson & Johnson should be held accountable for fraud and negligence for failing to provide consumers with a warning about alleged risks.”
Never-the -less, the FDA says ovarian cancer screening tests are often ineffective (FDA.gov).
In another recent lawsuit, pictures of bald children and women were presented in the media as alleged victims of Wen, a hair treatment promoted by hair stylist Chaz Dean.
Still another class-action lawsuit reported by
TheProductLawyers.com concerns EOS (Evolution of Smooth). The claim states the company misled consumers while ignoring serious adverse side-effects from one of its lip balm products, Summer Fruit. The plaintiffs’ claim the product causes blisters and rashes near the region of application.
One of the biggest factor in the new surge of lawsuits against cosmetic companies is the FDA’S warning letters sent in 2015-2016.The letters were quickly followed by lawsuits against some companies alleging the structure and function claims identified in the letters misled consumers into purchasing their products.
See some of the letters at: https://ruthwinterinsights.com/2016/10/28/warning-letters-from-the-fda/
The Personal Care Products Safety Act addresses many of the pitfalls in the cosmetic industry. But can the new regulations be enacted and have “teeth?
The Senate bill says the FDA must review the safety of at least five cosmetic ingredients each year. There are an estimated 11,000 products on the market— 25 percent of them from France, Cosmetic sales in the US are valued at $170 Billion dollars a year.
The bill also requires:
- The development and implementation of cosmetic manufacturing standards that are consistent with existing national and international standards.
- Officials be allowed to inspect a cosmetic company’s safety records
- The FDA be able to recall a cosmetic that is likely to cause serious adverse health consequences
- Encouraging safety testing practices that minimize the use of animals.
Will Bill 2014 pass and be enacted to law?
It has been in limbo of committee since April 2015. A number of bills to further regulate food additives and cosmetic ingredients have been submitted to Congress by consumer-minded legislators in the past few years. The bills. have died in committees.
The change an administration, in which the Trumps are users and purveyors of cosmetic, make it possible S-1014 will be emasculated or never survive its present holding place.
The Environmental Working Group (EWG) offers a database of more than 79,000 personal products ranked by level of hazard.
The FDA’s Cosmetic Database
Contains information about the safety, testing and regulation of cosmetics and personal care products and the ingredients they contain. Safety information is contained in a database of more than 2,000 ingredients
The primary purpose of the California Safe Cosmetics Program (CSCP) is to collect information on hazardous and potentially hazardous ingredients in cosmetics
A Consumer’s Dictionary of Cosmetic Ingredients by Ruth Winter, MS 7th edition
Based in Washington, D.C., the Personal Care Products Council http://irdb.personalcarecouncil.org/ ) is the leading national trade association representing the global cosmetic and personal care products industry. The trade group was formerly known as The Cosmetic, Toiletry, and Fragrance Association.