Skin and hair legislation: What’s happening?
Experts offer a primer on what dermatologists should keep their eyes on.
By Emily Margosian, Assistant Editor, February 1, 2023
On the heels of the start of the 118th U.S. Congress — which marks the first Republican House-Democratic Senate split in a decade — lawmakers and federal regulators continue to weigh new legislation pertaining to issues related to the hair and skin.
From decades-long efforts to codify FDA regulatory guidance on sunscreen to growing momentum regarding the prohibition of race-based hair discrimination, dermatologists can anticipate change on the horizon regarding legislation that impacts their practice and patients. This month, experts discuss with DermWorld what’s on this year’s docket and explain new developments in skin and hair law.
The CROWN Act
First introduced in 2019, the CROWN (Creating a Respectful and Open World for Natural Hair) Act aims to raise awareness of race-based hair discrimination and eliminate the practice nationally. “Legislation has been passed in a few states and would prohibit hair discrimination in educational and employment contexts against anyone based on the texture of their hair, hair type, or use of protective hairstyles like braids, locs, and twists,” said Lisa Albany, JD, AADA director of state policy.
According to Vinod Nambudiri, MD, MBA, EdM, FAAD, assistant professor of dermatology at Harvard Medical School, the successful passage of the CROWN Act should be of particular interest to dermatologists. “Race-based discrimination in any setting stands against the fundamental principles of justice and equity in our society. As dermatologists — whose expertise is in caring for individuals’ skin, nails, and hair — the CROWN Act is something that very much impacts the patients we see daily,” he explained. “For example, patients with forms of alopecia — who already experience a significant psychosocial burden due to their disease — may be particularly vulnerable to discrimination based on how they choose to wear their hair. Additionally, population-based surveys have shown that Black women and girls have been disproportionately subject to race-based hair discrimination policies; such policies may push individuals to adopt practices that ultimately prove detrimental or unhealthy, such as employing harsh chemical treatments and wearing tight or traction-based hair styles.”
“Race-based discrimination in any setting stands against the fundamental principles of justice and equity in our society. As dermatologists — whose expertise is in caring for individuals’ skin, nails, and hair — the CROWN Act is something that very much impacts the patients we see daily.”
To date, legislation has been enacted in 19 states, and a federal version of the bill passed a vote in the U.S. House of Representatives in March 2022.
The Personal Care Products Safety Act: A proposed update to an 85-year-old law
Since 1938, federal law regulating the safety of personal care products has remained largely unchanged. The Personal Care Products Safety Act, a bipartisan bill introduced in 2021, is intended to modernize the 85-year-old law governing the FDA’s oversight of these products, which include cosmetics, fragrance, lotion, body wash, shampoo, deodorant, and many other products used daily on the skin.
Although the FDA has oversight of personal care products, the agency currently has little legal authority to regulate them beyond requiring ingredients to be included on the product label. Under the present law, the FDA is also unable to issue a mandatory recall if a product or ingredient is found to be unsafe.
The bill outlines new responsibilities for both personal care product companies and the FDA. If the bill is enacted, companies would be required to:
Register facilities and disclose ingredients used.
Report serious adverse events to the FDA within 15 days and provide an annual summary of all reported adverse health events (including reactions such as rashes).
Provide specific labeling and warnings for products that may contain ingredients not suitable for the entire population.
The bill would also grant the FDA the authority to:
Issue a mandatory recall (if a company refuses to do a voluntary recall), similar to what is done for food products.
Develop regulations that outline good manufacturing practices for personal care products, similar to what is done for prescription and over-the-counter drugs.
Preempt state regulation if the FDA finds a personal care product ingredient to be harmful following the enactment of the bill.
Seize counterfeit cosmetic products and seek civil penalties for violations.
Collect user fees from manufacturers to fund oversight activities, similar to what is done for medications and medical devices.
The bill was introduced in the Senate in the last Congress and awaits action from lawmakers in the present Congress.
Regulatory update: Sunscreen
The FDA has a long history of sunscreen regulation, dating back to the early 1970s. In recent years, the agency has been tasked with updating its over-the-counter (OTC) sunscreen monograph.
In September 2021, the FDA released a proposed administrative order to update its OTC sunscreen monograph. “The proposed administrative order would serve as a roadmap for manufacturers to bring OTC sunscreens to market and provide a pathway to finalize outstanding questions around safety and labeling of sunscreen ingredients,” said Chad Appel, JD, AADA director of public policy and health care economics. “However, this long-awaited guidance is not final.”
The proposed order largely reflects what was outlined in the 2019 proposed rule on sunscreen. Highlights include:
Maximum labeled SPF value should be SPF 60+ while permitting the marketing of sunscreen products formulated with SPF values up to 80.
Sunscreens containing zinc oxide and titanium dioxide were deemed generally recognized as safe and effective (GRASE).
Aminobenzoic acid (PABA) and trolamine salicylate are not GRASE due to safety issues.
All sunscreens with SPF values of 15 and above must satisfy broad-spectrum requirements.
Updates proposed to sunscreen product labels, including an alphabetical listing of the active sunscreen ingredients in the product.
Sunscreen-insect repellent combinations are not GRASE due to inconsistencies in testing methods between FDA and the Environmental Protection Agency.
Alongside this announcement, the FDA also issued a deemed final order, which outlines all existing FDA regulatory guidance on sunscreens, dating back to the final rule released in 1999 (that was never implemented), and the 2011 labeling rules for sunscreens. “This release was required by the CARES Act and simply establishes what the current sunscreen requirements are,” explained Appel. “The proposed administrative order will modernize these established requirements with the latest science and research, and once finalized, will supersede these previous actions.”
As of yet, “the FDA has not indicated when the final rule will be released,” said Eric Austin Millican, MD, FAAD, chair of the AADA Regulatory Policy Committee. “The Academy appreciates the FDA’s mission to ensure the safety and effectiveness of over-the-counter sunscreen products based on sound science and supports orders that ensure the public has access to safe and effective sunscreens.”
The most recent regulatory activity at the state level regarding sunscreen has involved environmental bills, specifically in coastal areas. Over the past decade, there have been several studies that have shown the adverse effects of chemical UV filters on the environment, and the effect of key sunscreen ingredients oxybenzone and octinoxate on coral reefs.
However, “It should be emphasized that these studies were conducted in laboratory settings and more research is needed to understand the environmental effect of these UV filters,” cautioned Henry W. Lim, MD, FAAD, chair of the Academy’s Ad Hoc Task Force on Sunscreens in DermWorld’s 2020 feature “Sunscreens on trial.”
While more evidence is pending, several state and local governments have since moved to ban certain sunscreen products in recent years.
In Hawaii, the state prohibited the use of ingredients oxybenzone and octinoxate in 2018, which went into effect January 2021. In 2021, Maui County proposed a ban on the sale, distribution, or use of non-mineral sunscreens, which went into effect October 2022.
In Florida, the municipality of Key West banned oxybenzone and octinoxate in 2019. However, further action was halted in 2020 by Florida Gov. Ron DeSantis. “The 2020 law not only prohibits future bans, but also overturned the one that Key West passed,” explained Victoria Pasko, AADA assistant director of state policy. Presently in Florida, local municipalities are prohibited from banning the sale and distribution of sunscreens that contain ingredients being evaluated for potentially harmful effects to the environment. Current Florida law likewise blocks local regulations of all over-the-counter drugs and cosmetics, which include sunscreens and makeup containing SPF — effectively halting further action from local government for the time being.
At the federal level, recent activity concerning sunscreen regulation has been limited to the Reef Safe Act, a bipartisan bill which would require the FDA to develop standards for “reef safe” and “ocean safe” labels for sunscreen. If enacted, the bill would also require the FDA to reevaluate labeling criteria every 10 years, to reflect the best-available science. The bill was introduced in the House in the last Congress and awaits further action from lawmakers in the present Congress.
Additionally, the National Academies released their report in August on the environmental impact of sunscreens on aquatic life. Read the AADA’s statement.
Sunscreens on trial
Dermatologists discuss the debate about the effects of sunscreen ingredients on the environment.
Indoor tanning: Where do things stand?
After little movement in recent years, efforts to implement a nationwide indoor tanning ban for minors have begun to pick up steam. In 2015, the FDA proposed a new rule prohibiting minors under 18 years of age from using indoor tanning salons. However, further action stalled in subsequent years.
Last October, the initiative gained new momentum as Rep. Carolyn Maloney (D-N.Y.) led a congressional sign-on letter to FDA Commissioner Robert Califf, MD, urging the agency to finalize its proposed rules titled, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products (Docket No. FDA-2015-N-1765) and Sunlamp Products; Proposed Amendment to Performance Standard (Docket No. FDA-1998-N-0880). “These proposed rules would prohibit the use of tanning beds for minors under 18 years of age throughout the U.S. and ensure that performance standards for sunlamp products are updated to reflect current science and research,” explained Appel. “Manufacturers would also be directed to more visibly include the warning labels in informational brochures and marketing materials.”
To coincide with the congressional sign-on letter, the AADA and over 40 organizations joined a letter led by the National Council on Skin Cancer Prevention (NCSCP) urging the FDA to finalize its proposed sunlamp rules without further delay. “The AADA is a member of the National Council on Skin Cancer Prevention and worked closely with the NCSCP on advocating for the finalization of the sun tanning rules including lobbying Congress, signing on to a joint letter to the FDA, and meeting directly with FDA staff,” said Dr. Millican.
During a November 2022 meeting with the FDA, the AADA and NCSCP further urged the agency to finalize the two proposed rules on sunlamp products. NCSCP Co-Chair Boris Lushniak, MD, FAAD, led the meeting on behalf of the coalition and stressed the significant health risks for tanning beds — especially for adolescents.
While further action from the FDA is pending, tanning regulations have been mostly left to state and local governments to decide. To date, 44 states and Washington, D.C., either ban or regulate indoor tanning by minors to some extent.
Examining the monograph
DermWorld dissects the FDA’s proposed rule on the over-the-counter sunscreen monograph and what dermatologists might expect in the coming years.