The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic Act of 1938; however, the proposed Modernization of Cosmetics Regulation Act (MCRA) of 2018, will change the standards of cosmetics production and safety to that approximating food ingredients — a move that may be very costly and disruptive for some cosmetics companies. So, what is the history of cosmetics regulation and what can we expect from the MCRA?
A Short History of Cosmetics Regulation The first of the laws protecting consumers from harmful foods and worthless/dangerous drugs was the Pure Food and Drug Act of 1906. Passage of the Act of 1906 was in response, in part, to the discovery that much of the food available was adulterated with toxins such as formaldehyde as a preservative in milk or economically adulterated products such as mixtures of pectin, coal tar colors and sugar sold as fruit preserves. There was also considerable dispute over the quality of the drugs used to support troops in the Spanish-American War, in which President Theodore Roosevelt took part and saw the problems at first hand. The Pure Food and Drug Act was just a beginning however, with only a few laws addressing only the most egregious violations — reformers would have to wait 30 years for another national tragedy to get Congress to move against other nefarious practices.
Meanwhile, in the mid-1920s, a coal tar-based eyelash dye called Lash Lure had caused serious eye injuries including blindness and one death and, was still fresh in the mind of the public when the next tragedy came — the death of 107 people (most of them children) as the result of consuming “Elixir of Sulfanilamide”, an antibiotic that, instead of containing alcohol as a solvent, used ethylene glycol (the primary component of antifreeze).1 Also on the market at this time was a depilatory containing thallium (also used as a rat poison), that caused neurologic changes in some users resulting in paralysis. This time a bill was passed that included cosmetics in its title i.e., “The Food, Drug, and Cosmetic Act of 1938.” The 1938 act was a total reformation of the 1906 Act and it had some landmark reforms, including a mandate for safety testing before drugs were marketed to the public and a final jettisoning the safety per se standard (i.e., safe at any level of use). However, unlike drugs, cosmetics were not subject to a pre-approval process prior to placing a cosmetic on the market.
The Current Status of Cosmetics Cosmetics are defined in §201(i) of the Act as “(1) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” Cosmetics have been classified into several categories: skincare, fragrances, eye and other makeup, manicure products, hair coloring preparations, shampoos, deodorants, shaving products, baby products, bath oils and bubble-baths, toothpaste, mouthwashes2 (including breath mints or strips) and tanning products.
Changes the MCRA Proposes The responsible person, adverse event and proprietary information are described. Much like food and supplement regulations requiring reporting of adverse events, the MCRA defines an “adverse” event as “any health-related event associated with the use of a cosmetic product that is adverse”. Like food and dietary supplements, a reportable event (a “serious adverse event”) is one that results in “death, a life-threatening experience, inpatient hospitalization, disability or incapacity, congenital anomaly or birth defect or, significant disfigurement (e.g., persistent rashes or infections, significant hair loss or permanent and significant alteration of appearance) or, requires a medical or surgical intervention” to prevent an outcome described above.
This section also defines the “responsible person” — the manufacturer or distributor of a cosmetic product whose name appears on the label. The responsible person is obligated to report to the Secretary (of HHS)3 no later than 15 business days following the incident and describes the responsible person’s obligation in maintenance of adverse event records.
The composition of fragrances and flavor ingredients used in cosmetics are ordinarily not disclosed to the cosmetic manufacturer, because of the proprietary nature of these mixtures. However, the MCRA confers the authority to the Secretary to require disclosure of the contents by the fragrance or flavor blender/manufacturer. The MCRA is sensitive to the proprietary nature of these mixtures and accordingly, the Secretary is instructed to disclose this trade secret information only to the extent necessary to protect public health. Interestingly, there is a provision regarding protection of proprietary data as follows: “…A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (a)(2), or an adverse event report, or any new information, voluntarily [emphasis added] submitted to the Secretary…” This would imply that information not voluntarily submitted, will not undergo redaction to protect trade secrecy.
GMPs, Registration and Ingredient Listing The MCRA mandates the “Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards…”. In consideration of the resources and capital available to small businesses, GMPs for small businesses shall be made in consultation with the Small Business Administration. This provision for the treatment of small business entities is consistent with the requirement for compliance with GMP in stages.
All cosmetic manufacturing facilities will have to be registered and ingredients in the products labeled with each “ingredient identified by the name adopted in the regulations promulgated by the Secretary, if any, or by the common or usual name of the ingredient”. This requirement may lead to loss of cachet with trade names and an eventual issue concerning the proper name of a substance. Also required will be “a list of any fragrances, flavors or colors that may be interchangeable in the cosmetic product using the name or code provided by the supplier, and including the name and contact information of such supplier”. The MCRA also stipulates that the ingredients meet the safety standard also used for food ingredients (i.e., “a reasonable certainty”) that the product will not be injurious to health according to the suggested conditions of use.
Safety Standard and Ingredient Review Interestingly, the proposed safety standard is a high threshold, “a reasonable certainty of no harm,” the same as for food ingredients and greater than the standard of safety for dietary supplements (i.e., a “reasonable expectation of no harm”). Why this higher standard? Some might argue that because most cosmetics are applied externally, a lower standard should prevail; however, there are some cosmetics that are swallowed such as breath fresheners and lipstick and others applied to or having access to sensitive areas, such as vaginal sprays and bath bombs. The proposed standard is as follows:
(a) In General — For purposes of this chapter, a cosmetic or cosmetic product is safe if there is a reasonable certainty that the cosmetic or cosmetic product is not injurious to health under conditions of use suggested or recommended in the labeling or, if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use. A cosmetic ingredient or nonfunctional constituent may not be considered injurious to health solely because it can cause minor adverse health reactions, such as minor and transient allergic reactions or minor and transient skin irritations, in some users.
Importantly, this is not a safety per se standard (that is, safe at any use level), but instead, “not injurious to health under conditions of use suggested or recommended in the labeling [or in the absence of a suggested use] under ordinary conditions of use”. Further, the standard has a tolerance for minor adverse reactions, transient allergic reactions and skin irritations.
The MCRA will also require that the Secretary identify (not less than) 10 cosmetic ingredients or non-functional constituents4 “to be assessed for purposes of public health” and upon completion of this assessment, the Secretary may identify other ingredients to be assessed. The ingredients will be compiled into a list and subject to public notice and an opportunity for public comment — a provision also exists that some of the ingredients may be removed from the list. In each year that the Secretary starts a new list, the Secretary shall initiate a request for scientific data. Once each list is selected, the Secretary “shall open a docket for a period of 180 calendar days to solicit public comment, including State assessments, reviews by external organizations, and scientific data relevant to the safety of each such cosmetic ingredient or non-functional constituent”. A public posting soliciting comments will undoubtedly be the beneficiary of helpful proprietary information, but probably also vindictive comments from trolls and competitors as well as comments regarding sustainability, organic substitutes and pleas to avoid animal testing. Within 90 days of closing the comments the Secretary must either initiate an ingredient review or publicly indicate which ingredients are eligible for review by an accredited person to determine if the safety standard is met.
Interestingly, no exemption is included in the proposed legislation for ingredients already in use (i.e., no “grandfathering”) or, ingredients already approved via GRAS, a food additive regulation or prior sanction; likely because cosmetic use would count as an additional exposure over and above the original food or supplement use). Because many of the original flavor (and fragrance) ingredients were found compliant with federal law as the result of a history of prior use (i.e., prior to January 1, 1958), by default, safety data may have to be generated.
Safety Assessments According to the proposed MCRA, either the Secretary or an accredited person must make the determination that the ingredient meets the safety standard. This reference to accredited persons should provide a sigh of relief from industry as not knowing what the FDA’s priorities might be, the ingredient safety assessment could take the same amount of time as it takes to get approval of a food additive and, FDA being a conservative agency, might require more information for a determination of safety as would an “accredited person”. Further, for this determination the safety assessor “…shall consider competent and reliable scientific evidence including as appropriate and available, any such evidence that may relate to conditions of use or tolerances, such as cumulative or other relevant exposure, and any evidence regarding certain populations, such as pediatric populations”. Once the data examination is complete, the safety assessor may assign one of the following conclusions:
(A) is safe for use in cosmetic products without the need for specified conditions of use or tolerances; (B) is safe for use in cosmetic products under specified conditions of use or tolerances; (C) is not safe for use in cosmetic products, under specified conditions of use or tolerances; (D) not safe for use in cosmetic products; or (E) does not have sufficient evidence to support a determination of safety.
Once an assessment is completed, the Secretary is required to solicit public comments on the assessment.
Accredited Persons for Review of Cosmetics Ingredients With all its other priorities, FDA simply does not have the resources to perform safety assessments for all the cosmetic ingredients, nor the wherewithal to review them at a rate that would not obstruct commerce in cosmetic ingredients – help is needed in the form of accredited persons. A source of help is at hand. Because cosmetic ingredients and flavor ingredients have long been self-policing with such groups as the Cosmetic Ingredient Review and the Expert Panel of the Flavor and Extract Manufacturers’ Association, the members of these groups would be likely candidates for accreditation. In addition, because the substances for review would be too numerous even with the addition of these aforementioned groups, it is likely that independent consultants would be pressed into service as candidates for accreditation.
The proposed MCRA requires the Secretary to accredit persons for the purpose of assessing the safety of cosmetic ingredients and to publish criteria for accreditation in the Federal Register. The Secretary is required to approve or deny a request for accreditation within 60 days of application and, if approved, the accreditation would be valid for five years. The proposed statute actually lays out minimal criteria for accreditation:
(A) is not be an employee of the Federal Government; (B) is an organization which is not owned, managed or controlled by a responsible person, manufacturer, processor, supplier, or vendor of articles regulated under this section and which has no material organizational or financial affiliation (including a consultative affiliation) with such entities; (C) does not engage in the distribution, manufacture, promotion, or sale of cosmetics; (D) has procedures to ensure against the use of any officer or employee of such accredited person that has a financial conflict of interest regarding an ingredient or non-functional constituent to be reviewed by such accredited person; (E) shall annually make available to the Secretary disclosures of the extent to which such accredited persons and the officers and employees of such accredited person have maintained compliance with subparagraphs (B), (C), and (D); (F) has the ability and staff with the appropriate expertise, backgrounds, and experience to access, manage, assess, and interpret information regarding cosmetic ingredient safety, toxicology, chemical safety, and endocrinology; (G) is a legally constituted entity permitted to conduct the activities for which it seeks accreditation; (H) has the appropriate systems and procedures in place to ensure the protection of proprietary business information; and (I) has operations in accordance with generally accepted professional and ethical business practices and agrees in writing that, at minimum, it will: “(i) certify that reported information accurately reflects data reviewed; “(ii) limit work to that for which competence and capacity are available; “(iii) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited.
These criteria are relatively specific and likely reflect the FDA’s dissatisfaction with the credentials of GRAS Expert Panelists5 and described in the March 2018 Burdock Advisor.6 These criteria would also seem to eliminate non-certified toxicologists (e.g., lacking accreditation by the American Board of Toxicology)7 or, those who cannot demonstrate appropriate infrastructure including, but not limited to appropriate systems and procedures to ensure the protection of proprietary business information and record keeping. Importantly, any direct connection with a cosmetics company (such as a subsidiary of a cosmetics company) is precluded from accreditation; so therefore, while a cosmetics company might have an in-house safety team to prepare data for submission to FDA or their consultant, the in-house safety team could not be accredited.
Follow-Up by the Secretary To ensure the law does not fall on deaf ears or regulation is slow-walked through the FDA, the proposed MCRA requires biennial reports to Congress, which will include a list of ingredients reviewed, serious adverse event reports, the number of registered facilities and the number of facilities inspected during the fiscal year, enforcement actions and the efforts FDA has made to reduce animal testing.
The proposed MCRA also requires the Comptroller General of the United States to follow up with the actions the FDA has taken on the actions directed by the proposed MCRA.
Concluding Thoughts The proposed Modernization of Cosmetics Regulation Act of 2018 represents an initiative by Congress to direct the FDA to take a more activist approach to oversee the safety of cosmetics. This action by Congress, in the absence of a precipitating catastrophic event, restores much of the lost faith in our legislators. Further, rather than simply directing FDA to take an action or series of actions as was done for the Food and Drug Modernization Act or the Dietary Supplement Health and Education Act only to see the intent of Congress subverted by an activist agency, Congress has been very specific in the way the MCRA will be implemented (although because of space considerations, only a few of these specifics have been described here). Also, in as much as Congress has sometimes drafted legislation that seemed punitive to industry, this proposed MCRA seems fairly even-handed. Although as with any new law, not everyone will be pleased — the cosmetics industry, while historically not been the subject of much regulatory oversight, will no longer have the free reign it once had. Also, some self-anointed “experts” in safety will be eliminated, but to the benefit of the public and, the credentials and the rationale for a statement of safety will become more transparent, much to the pleasure of bona fide experts in the field. Lastly, the proposed MCRA represents a victory for the consumer, who can depend on the safety of “articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance.”
References:
An interesting story and milestone in FDA history. A summary of the event is available upon request at info@burdockgroup.com. Just ask for “Warning Letters, Recalls and the Elixir of Death”.
Toothpaste and mouthwash remain cosmetic products in the absence of claims such as caries prevention or antisepsis.
On whose behalf, the FDA Commissioner will act.
Hereinafter, ingredients or non-functional constituents, will be referred to as simply, ingredients.
Best Practices for Convening a GRAS Panel: Guidance for Industry. Site accessed Feb. 19, 2018.
FDA’s Hostile Take-Over of GRAS, Part II: FDA’s Assault on Legitimacy of GRAS Expert Panels. Burdock Group Advisor, March 2018.
As required by the Consumer Product Safety Commission for assessing the safety of art materials,