Have you had an adverse effect from a cosmetic?
Did you report it to the FDA?
The reporting of adverse effects associated with a cosmetic product is voluntary. In 2014, for example, Steve Xu, M.D., a dermatologist at Northwestern University and his colleagues investigated WEN, a shampoo/conditioner. The FDA had received 127 customer complaints about the product. The adverse effects included hair loss, brittle hair, bald patches, itching, and rashes. An investigation by Steve Xu, M.D., a dermatologist, Northwestern University’s Feinberg School of Medicine and his associates discovered the WEN’s manufacturer, Chaz Dean Cleansing Solutions, had received an unreported 21,000 complaints about the product.
There has been almost no significant updates of the Federal Food, Drug, and Cosmetic Act (FFDCA) since its original adoption in 1938. Therefore, the media and consumer groups, including the New York Times, were enthusiastic about recently proposed Senate regulations of cosmetics put forward by US Senators:
- The Personal Care and Safety Act 1113 introduced May 11,2017 by Senators Dian Feinstein (D-CA) and Susan Slaughter (R-ME).
- The FDA Cosmetic and Modernization Act S. 2003 introduced by Senator Orin Hatch (R-Utah) on October 25, 2017, just five months after Feinstein and Slaughter’s
The wrinkle in the proposed cosmetic legislation, however, is the bills have been sent to the limbo of the Senate’s Committee on Health, Education Labor and Pensions. In my experience, researching seven editions of A Cosmetic Dictionary of Cosmetic Ingredients beginning in 1972, it is doubtful either bills will emerge from the Committee. Senator Feinstein had introduced a similar cosmetic bill April 20, 2015. Congress adjourned, and the bill was not enacted. Even if the bill had been passed by the Senate, it would then have had to pass the House and be signed by the President before coming to life.
Would President Donald Trump sign either of the two proposed Cosmetic Regulation Senate bills? He could ask his daughter, Ivanka, who is in the cosmetic business.
I have listed my own opinion of certain proposed bill clauses by (RW: __)
The Feinstein-Slaughter Bill S.1113 does address many of the regulations consumer groups maintain are missing:
- Cosmetic makers must report their facility exists to the FDA. (RW: currently reporting is voluntary, and anyone can be in the cosmetic business.)
- Companies must pay a facility registration fee based on their annual gross sales of cosmetics. The collected fees can only be used for cosmetic safety activities. (RW: hopefully.)
- If the FDA determines a cosmetic has a reasonable probability of causing serious adverse health consequences, the agency may prohibit the cosmetic’s distribution by suspending the cosmetic ingredient statement. If other cosmetics from the same facility may be affected, the FDA may prohibit distribution from that facility by suspending the facility’s registration. (RW: If the Agency is unaware of its existence because registration and reporting are voluntary, it makes enforcement difficult— especially since the FDA can only request manufacturers to take products out of circulation.)
- The FDA must review the safety of at least five cosmetic ingredients each year (RW: there are more than 1,000 ingredients in use) and it may establish conditions for safe use of an ingredient, including a limit on the amount of the ingredient or a requirement for a warning label. A cosmetic cannot be sold if it contains an ingredient that is not safe—under the recommended conditions of use, or in the amount present in the cosmetic.
- Cosmetics companies are required to report to the FDA any serious adverse health event associated with their cosmetics. (RW: good! It is now voluntary).
Senator Orin Hatch’s legislation presents an alternative to the Feinstein-Slaughter bill, S1113. His proposed legislation would:
- Allow the Food and Drug Administration (“FDA”) to regulate finished cosmetic products based on their safety and the safety of their components. (RW: no individual ingredient should be evaluated?)
- The third party may not be affiliated with a government entity. (RW: what about the Food and Drug Administration?) Such third party shall be an independent organization that is not owned or controlled by a manufacturer, supplier or vendor of cosmetics and that has no financial affiliation with such a manufacturer, supplier, or vendor.
- The third party shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.
- Such third party shall not engage in the design, manufacture, promotion, or sale of cosmetics.
- Such third party shall have scientific expertise in ingredient safety, toxicology, or chemical safety. (RW: toxicologists are in short supply. The ones in practice work for private agencies or university labs which are usually funded by the industry).
- The operations of such third party shall be in accordance with generally accepted professional and ethical business practices and such third party shall agree in writing that it will.
- The submission of any adverse event report under this section shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event. (RW: Huh?)
- The manufacturer or distributor of a cosmetic whose name appears on the label shall submit to the Secretary any report received of a serious adverse event associated with such cosmetic when used in the United States, accompanied by a copy of the label on or within the retail packaging of such cosmetic. (RW: This is good.)
An adverse cosmetic effect can mean any result from a life-threatening experience to a rash.
The Hatch Bill requires cosmetic manufacturers to register all facilities engaged in manufacturing of cosmetics with the Agency Secretary except for:
- Beauty salons, spas, retailers (including individual sales representatives, wholesale distributors, or pharmacy locations);
- Homes where persons are engaged in making handcrafted soaps or other cosmetics. (RW: potential loophole)
- Any business with less than $1,000,000 in annual net revenue in the previous year, other than any such business that is engaged in the manufacturing or processing of products intended to be injected under the skin, including tattoo ink. (RW: potential loophole)
Senator Hatch’s bill would authorize chemical safety reviews but would not impose any associated requirements or timelines on FDA. The Feinstein-Collins bill would require FDA to review five cosmetic ingredients a year. The Utah senator’s bill authorizes accredited third-party organizations such as the Cosmetic Ingredient Review funded by the trade organization (CIR) and The Personal Care Products Council (PCPC) to assess the safety of cosmetic ingredients and make recommendations to the agency. The organizations may not be affiliated with a government entity or controlled or financed by a cosmetics company. (RW: The government agencies such as FDA and the FTC may be excluded? The FDA currently allows many cosmetic makers to evaluate their own products and report their findings to the Agency to gain FDA approval listing.)
The Hatch bill does require companies to notify the FDA of any report received about a serious adverse event associated with their cosmetics. (RW: good!)
Senator Hatch’s bill is praised by personal care trade groups and criticized by consumer groups and The Feinberg- Slaughter bill is criticized by cosmetic trade groups and supported by consumer groups.
Hatch Bill S2003 says only the Commissioner may suspend the registration
Lawyers who specialize in cosmetic regulations advises the industry to watch out for Proposition 65.  In 1986, California voters approved Proposition 65 to address growing concerns about exposure to toxic chemicals – such as suspected of causing cancer or birth defects. (RW: There are ingredients in cosmetics reported to cause cancer and/or birth defects and I list many of them cited by the National Cancer Institute and Other agencies as well non-profit organizations. Senator Hatch’s bill depends on congressional appropriations for funding. The Feinstein-Collins legislation allows FDA to collect user fees from industry.
Feinstein-Collins requires FDA to conduct safety chemical reviews, while the Hatch bill would allow third parties to review the chemicals to regulate cosmetics
Let’s see, if the S.1113 and S.2003 are ever enacted.
 Steve XU, MD, dermatologist, Northwestern University’s Feinberg School of Medicine and his associates, Chicago; Doris Day, MD dermatologist, Lenox Hill Hospital, NYC; June 26, 2017, JAMA Internal Medicine, online,
 A Consumer’s Dictionary of Cosmetic Ingredients 2009, NY. (Amazon: ruthwinterbooks.com)
 Safer chemicals (saferchemicals.org)a coalition of 450 consumer groups and Environmental Working Groups (ewg.org).