Will 2019 be the Year of Federal Cosmetics Regulation?

Posted by:

2019 is starting to look like the year Congress may make good on its efforts to pass federal cosmetics reform legislation, with legislation in the works in both the U.S. Senate and the U.S. House of Representatives that would increase federal regulatory oversight for cosmetics. In addition, Senate and House committees have been active in demanding more information and action from the Food and Drug Administration (FDA) to ensure cosmetics safety.

Feinstein/Collins Personal Care Products Safety Act Bill

As they have in previous sessions of Congress, Sens. Dianne Feinstein (D-California) and Susan Collins (R-Maine) re-introduced the “Personal Care Products Safety Act” (S. 726) in March, a bill that would strengthen the FDA’s efforts to regulate ingredients in personal care products.

The Personal Care Products Safety Act bill would amend the Federal Food, Drug & Cosmetic Act (FDCA) by:

  • • Requiring annual registration of cosmetic facilities with the FDA and impose tiered registration fees;
  • • Requiring cosmetic ingredient statements for all cosmetics, including fragrances, flavors and colors, as well as a range of possible amounts of each ingredient;
  • • Providing the FDA the authority to suspend registration of a facility (and any import, export or distribution of cosmetics from the facility) or a cosmetic ingredient statement (and all cosmetics that are the subject of the statement) if there is a reasonable probability of serious adverse health consequences or death to humans;
  • • Directing the FDA to review ingredients and non-functional constituents, including coal tar chemicals) for safety at a rate of at least five ingredients per year;
  • • Directing the FDA to issue regulations to establish Good Manufacturing Practices for cosmetics;
  • • Requiring timely reporting of serious adverse events and annual reporting of adverse events;
  • • Allowing the FDA wide authority to inspect records;
  • • Providing mandatory recall authority to the FDA;
  • • Requiring labeling of cosmetics that are not appropriate for use in the entire population, including warnings that vulnerable populations, such as children or pregnant women, should limit or avoid using the product;
  • • Requiring ingredients, warnings and statements on professional products;
  • • Requiring complete label information to be placed online for online sales of cosmetics; and
  • • Requiring a telephone number or electronic contact information on the label.

In the first year, the FDA would evaluate the safety and appropriate use of the following five chemicals, which could be banned from cosmetics or limited in their allowed use:

• Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion.
• Diethyl phthalate, which is used as a binding agent in some fragrances and cosmetics.
• Methylene glycol/formaldehyde, which is used in hair treatments.
Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion.
• Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.

Pallone/Shimkus Discussion Draft

Meanwhile, House Energy & Commerce (E&C) Committee Chairman Frank Pallone Jr. (D-NJ) and Rep. John Shimkus (R-Ill.) in March released a bipartisan discussion draft of legislation that is very similar to the Personal Care Products Safety Act, which is expected to be introduced in the House soon.

Action by Congressional Committees

Congressional committees have also been flexing their investigative and oversight muscles by demanding additional information from and calling for more action by the FDA, separately from the status of any reform legislation.

After the FDA announced in March that its testing (almost two years after the fact) confirmed the presence of asbestos in cosmetics, including eye shadows, compact powders and contour palettes, sold in 2017 at children and teen stores Claire’s and Justice stores, Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called for further investigation by the FDA into whether cosmetic products that contain talc “may be contaminated with asbestos.”  Sen. Murray is also urging the FDA to conduct additional testing to ensure the safety of cosmetic products containing talc, and in particular cosmetics that are marketed to children and teenagers.  Separately, Sen. Murray demanded that Claire’s provide more information about the possible sources of asbestos contamination and the process and procedures Claire’s takes to assess the safety of its products before they reach customers.

There have been further regulatory and legislative developments on these subjects in June 2019. Additional cosmetics, including a JoJo Siwa makeup set sold by Claire’s, were found to be contaminated with asbestos and were recalled in June 2019. Rep. Pallone then sent a letter to the FDA requesting updated information about the agency’s inspections of imported cosmetic products. Specifically, Rep. Pallone sought FDA foreign inspections data from Fiscal Year (FY) 2017-2019, including the number and kinds of personal care products imported each year, the number of imported products subjected to inspections each year, and the number of contaminated products intercepted each year. According to Rep. Pallone, the FDA has not conducted any foreign cosmetic inspections in FY 2019 and intends to conduct no foreign cosmetic inspections in FY 2020.

This was not the first such request to the FDA, as Rep. Pallone previously sent a letter to the FDA requesting similar information in 2016. In response, the FDA stated that in FY 2016, less than one percent of cosmetic products that arrived in U.S. ports were physically examined by FDA inspectors; of those inspected, inspectors reported adverse findings such as illegal color additives and microbial contamination in 15 percent of the imports.

The push toward federal cosmetics reform has been many years in the making, and now gathers industry support from such heavyweights as The Estee Lauder Companies, Johnson & Johnson, L’Oreal and Procter & Gamble.  While the industry by and large appears to agree that updates are needed to the current regulatory system and would increase consumer confidence, there are concerns about the extent of the reform and the scope and breadth of the power to be vested in the FDA.  Key stakeholders are involved in the process and engaging with the House, Senate and FDA. 

While it remains to be seen whether 2019 will be the year of significant cosmetic legislation reform, one thing is certain – increased regulation for the personal care products industry is inevitable, and the question is just one of how much regulation and the extent to which the FDA will preempt state and local regulations.

Cosmetics manufacturers should take heed as they plan their product formulations, manufacturing and labeling of existing and planned product lines, whether made in the U.S. or abroad. Conkle, Kremer & Engel attorneys stand ready to help clients plan their responses to current and developing regulatory changes affecting the beauty industry.

0

Conkle Firm Attorneys and PCPC Lobby California Legislature about SB 574 and AB 495

Posted by:

On April 3, 2019, Conkle, Kremer & Engel attorneys John Conkle and Raef Cogan joined the Personal Care Products Council (“PCPC”) in Sacramento, California to lobby members and staff of the California Legislature on pending legislation important to members of the personal care products industry, including Senate Bill 574 and Assembly Bill 495.

CK&E attorneys, PCPC staff and participating industry representatives visited legislative offices to advocate for positions favored by personal care products industry members. Over the course of more than 15 meetings with legislators and their aides, the group focused its advocacy on two pending bills that, if enacted, would have significant consequences for the U.S. cosmetics industry as a whole. Conkle, Kremer & Engel has previously written about Senate Bill No. 574 (“SB 574”) introduced by Senator Connie Leyva and Assembly Bill No. 495 (“AB 495”) introduced by Assembly Members Al Muratsuchi and Buffy Wicks. These are important bills that if enacted would have significant consequences for the U.S. cosmetics industry as a whole.

SB 574, also known as the “Toxic Fragrance Chemicals Right to Know Act of 2019,” would require cosmetic manufacturers to disclose fragrance of flavor ingredients that appear on any one of 27 “designated lists.” CK&E attorneys explained during the meetings that a viable version of this bill may be presented in the future, but that as written SB 574 threatens cosmetic companies’ confidential business information, results in duplicative regulation and relies on faulty, unscientific “lists” to determine what information manufacturers must disclose.

AB 495, is entitled the “Toxic Free Cosmetics Act,” and would dramatically increase the number of cosmetics listed as “adulterated,” without justification. CK&E attorneys explained that under AB 495 as proposed, any cosmetic that contained even trace amounts of identified ingredients would be labeled “adulterated” and would be banned outright. Some ingredients sound scary, like lead, but are in fact naturally occurring and cannot be completely eliminated from cosmetic (or many other) products. Others are preservatives that have been deemed completely safe for use in cosmetics by the FDA and other regulatory bodies.

Both SB 574 and AB 495 are coming up for committee vote soon. Conkle, Kremer & Engel will stay apprised of the results and will provide updates on this legislation that is important to the cosmetics industry.

PCPC California Lobby Day also featured presentations from Allen Hirsch, Chief Director of the California Office of Environmental Health Hazard Assessment (“OEHHA”), Karl Palmer from the Department of Toxic Substances Control (“DTSC”), Joseph Calavita from the Air Resources Board, and Senator Bill Quirk, Chair of the Environmental Safety and Toxic Materials Committee. The regulators spoke about important upcoming actions by their agencies. Senator Quick focused on the importance of protecting our environment from toxins, primarily greenhouse gasses. Each of these presenters stressed a need for more information sharing between the industry and the respective regulatory and legislative bodies.

0

Manufacturers, Suppliers and Resellers Must Plan for California’s New Cruelty Free Cosmetics Act

Posted by:

Almost no one favors animal testing for cosmetics.  The beauty market trend has been strongly away from animal testing, as demonstrated by the recent announcement of Coty, Inc.’s CoverGirl brand being certified cruelty free.  That’s why the personal care products industry supported California’s new Cruelty Free Cosmetics Act, SB 1249, which was unanimously passed by the California State Assembly and signed into law by Governor Brown on September 28, 2018.  The new Act does not take effect until January 1, 2020, but compliance will require cosmetics businesses to plan ahead.  The new Act may present some thorny and perhaps unexpected issues and risks for importers, manufacturers, distributors and resellers of beauty products and ingredients in California.

The new Act is found at Section 1834.9.5 of the California Civil Code, immediately following the existing animal testing law that has been in effect since 2000.   That existing law, Section 1834.9, continues to prohibit manufacturers and testing facilities from using animal testing when alternative methods have been scientifically validated and recommended by responsible agencies.  But the existing law has limited application, and the new Act significantly expands on the prohibitions of animal testing for cosmetics and their ingredients.

Generally, the Act prohibits a manufacturer from importing, offering or selling in California any cosmetic that “was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020,” with specified exceptions.  The first observation must be that the new Act will not apply to any manufacturer’s cosmetic or ingredient that was previously subject to animal tests.  The natural effect is that the Act generally does not apply to a manufacturer’s existing cosmetic ingredients and product formulations, even if the cosmetic or ingredient is manufactured after January 1, 2020.

However, manufacturers and importers need to note that the Act certainly can affect development of new cosmetic formulations, and so it will have a strong impact on use of innovative cosmetic ingredients in new or reformulated products.  This can impede participants in the personal care products industry who strive to develop new ingredients to improve and differentiate their products.  Scientifically-reliable alternative non-animal test methods can be slow to develop and receive approval by regulatory agencies, so the inability to conduct animal testing could inhibit the introduction of new cosmetic ingredients, particularly potentially complex ingredients such as new surfactants or polymers.

There are some exceptions to application of the new Act, but they may defy easy workaround solutions.  The first major exception is a multi-step assessment that exempts application of the Act if the manufacturer can establish all of these elements:

  1. An animal test is required by a U.S. federal or state regulatory authority, and no non-animal alternative testing method is acceptable;
  2. The ingredient tested is in wide use and cannot be replaced by another ingredient with similar function; and
  3. The need to conduct animal tests is justified to address a specific substantiated human health problem and supported with a detailed research protocol.

The multiple elements required for this exception are so demanding that its practical utility is doubtful.  But there are two additional exceptions that on first blush appear deceptively simple to apply:  First, if animal testing is required by a foreign regulatory authority for export to that country, the animal-tested product does not for that reason violate the new Act.  This was an important exception favored by the industry, because without it cosmetic products could not be readily exported to foreign markets, like China, that require animal testing.  The second exception applies if animal tests were required to be performed on an ingredient for non-cosmetic purposes.  In other words, if some animal testing was done on the ingredient for non-cosmetic purposes, or was required for exporting the product, that animal testing in itself will not preclude use of that ingredient in a cosmetic product.

On their face, these last two exceptions seem like they create large loopholes in the Act.  But looks can be deceptive.  Both of these exceptions are narrowed by an additional term that prohibits the manufacturer from relying on evidence of the animal testing to substantiate the safety of cosmetics sold in California.  California and the FDA require that “Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing.”  (21 CFR 740.10(a))  There are few meaningful guidelines about what “adequate substantiation” of safety means, or exactly what records are required to be maintained to show such substantiation, but it is clear such substantiation must exist “prior to marketing.”

So the effect of the new Act is to prohibit manufacturers offering products in California from relying on animal testing as part of their “adequate substantiation of safety” before selling their products, even though the animal testing itself did not violate the Act due to the noted exceptions.  This limitation effectively requires manufacturers to somehow show separate, non-animal testing to have adequate substantiation of the safety of their ingredients and products prior to marketing.  That in turn renders the animal testing that was permitted under the exceptions useless to support the safety of cosmetic sales in the California market.

The safety substantiation requirement has yet another twist that may present a significant risk to manufacturers selling cosmetics in California after the new Act becomes effective:  Although no federal or California state law specifies how or what documentation of safety must be maintained, the new Act both permits and motivates district attorneys and city attorneys, upon their determination of “a reasonable likelihood of a violation,” to “review the testing data upon which a cosmetic manufacturer has relied in the development or manufacturing” of the product sold in California.  Given that violators can be fined $5,000 initially plus $1,000 per each day that a violation continues, which fines are payable directly to the city or county attorney’s office, district attorneys and city attorneys have powerful motivation to aggressively pursue possible violations.

It seems the legislature was sufficiently concerned about this “adequate substantiation” issue that it was felt necessary to specify in the Act that a manufacturer “is not prohibited from reviewing, assessing or retaining evidence from an animal test conducted” for non-cosmetic purposes (though, oddly, the Act says nothing about that for the separate “foreign regulatory” exception).  So just having an animal test in the manufacturer’s file may not violate the Act, but the manufacturer still cannot rely on those tests when a DA or city attorney comes calling.  Manufacturers must determine how they will maintain records to show adequate substantiation of the safety of all of their ingredients and product formulations, prior to marketing, without running afoul of the Cruelty-Free Cosmetics Act.

The new Act does not itself create a new private legal claim, which means that (unlike some other California consumer protection statutes like Proposition 65) bounty-hunter plaintiff lawyers will not have direct motivation to pursue claims under the Act.  However, that has not stopped creative plaintiffs’ attorneys from bootstrapping other consumer product regulatory violations as bases for civil lawsuits, such as “Unfair Business Practices” claims under Business & Professions Code Section 17200 et seq., and even class actions under the Consumer Legal Remedies Act (CLRA), California Civil Code Section 1750.  It is also not difficult to imagine competitors making claims of unfair competition based on allegations that a competing cosmetics brand violated California’s animal testing laws, perhaps including false advertising claims for good measure.

Cosmetics manufacturers and their suppliers have a little over a year to ensure that their cosmetics and ingredients made, imported or sold in California will be compliant with the Cruelty Free Cosmetics Act.  More challenging still, manufacturers, importers and ingredient suppliers will have to plan for development of new cosmetics and ingredients, with adequate substantiation of their safety that does not depend on animal testing results. Conkle Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate California’s fast-changing regulatory landscape.  If you have questions in this or other consumer product regulatory areas, contact CK&E at [email protected] or 310 998-9100.

0