As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. We will focus on MoCRA’s mandate requiring the Federal Drug Administration (FDA) to establish Good Manufacturing Practices (“GMP”) that the cosmetic industry will have to follow going forward.
In the past, the FDA issued nonbinding, voluntary guidance related to best practices in cosmetics manufacturing. The FDA’s former guidance offered GMP recommendations to reduce the risk of adulterating or misbranding cosmetics and effectively conduct a self-inspection to rate cosmetic manufacturing operations.
Under MoCRA, the FDA is now required to establish mandatory GMP regulations and Section 606 of MoCRA details this process. Pursuant to Section 606, the FDA is required to issue a notice of proposed rulemaking pertaining to the GMPs by December 29, 2024, and a final rule by December 29, 2025. The FDA is also given the authority to conduct inspections of records and facilities to ensure compliance with its new GMP regulations.
How Will the GMPs Apply to Small Businesses?
In establishing the GMPs, the FDA must take into consideration the practicability of the new regulations based on the size and scope of each business to ensure flexibility and feasibility. These types of flexible GMP schemes have been implemented by the FDA for other regulated industries. For example, the FDA’s medical device Quality System Regulation is less prescriptive and gives the manufacturers the flexibility to determine the controls that are necessary and commensurate with the risk.
In a similar vein, MoCRA provides that “smaller businesses” shall be subject to “simplified good manufacturing practice requirements . . . to ensure that such regulations do not impose undue economic hardship.” Of note, MoCRA specifically uses the term “smaller businesses,” which is distinct from a “small business.” A “small business” will be entirely exempt from the GMP regulation. A “small business” is defined as a business having average gross annual sales in the United States for the previous three-year period of less than $1 million, but does not manufacture a cosmetic product that:
- is intended for internal use,
- is injected,
- alters the appearance for more than 24 hours, or
- regularly contacts the mucus membrane of the eye.
The FDA’s Earlier Proposed Draft GMPs
In 2013, the FDA published a draft guidance pertaining to GMPs, which is available here. The FDA intends to either withdraw the draft guidance or revise and reissue it, based on the GMP rulemaking required by MoCRA. The 2013 draft guidance addressed various topics, the most notable of which are as follows:
|Documentation is to create a mechanism that shows how products are manufactured and tested. Documentation should define and capture every aspect of your manufacturing process. Documentation should also trace where any problems may have occurred and how to take appropriate corrective action.
|Records must capture in detail the operations, procedures, deviations from procedures, justifications, instructions (including training), specifications, protocols, reports, methods, precautions, corrections and other measures, and other appropriate information related to GMPs. With respect to the raw materials, records should reflect the raw material’s origin, receipt, examination, testing, disposition, and use. Batch production records should include documentation of all ingredients (name, code, lot number, quantity, etc.) added to the batch; documentation of all production steps (for example, processing, handling, transferring, holding, and filling); in-process sampling, controlling, and adjusting steps; batch and finished product lot or control numbers; the finished products control status – accepted or rejected; and laboratory records for raw materials should include documentation of sampling procedures, test results, and interpretations of test results.
|Buildings and Facilities
|Cosmetic manufacturing “buildings and facilities” must be of suitable size, design, and construction, and maintained in a clean and orderly manner. Buildings should provide space of sufficient size and adequate organization to prevent selection errors (i.e., mixups) or cross contamination between consumables, raw materials, intermediate formulations (i.e., in-process materials), and finished products. Adequate filth and pest controls must be in place. Floors, walls, and ceilings constructed of smooth, easily cleanable surfaces. Adequate lighting and ventilation, and, if necessary for control purposes, screening, filtering, dust, humidity, temperature, and bacteriological controls must be in place. Adequate washing, cleaning, plumbing, toilet, and locker facilities to allow for sanitary operation; cleaning of facilities, equipment, and utensils; and personal cleanliness must be in place. Fixtures, ducts, pipes, and drainages must be installed to prevent condensate or drip contamination.
|The equipment and utensils used in processing, holding, transferring, and packaging of cosmetics must be of appropriate design, size, material, and workmanship for the intended purpose to prevent corrosion, accumulation of static material and/or adulteration with lubricants, coolants, dirt, and sanitizing agents.
|Personnel supervising or performing cosmetics manufacturing or control must have the education, training, and/or experience to perform their assigned functions. Personnel coming in direct contact with cosmetic raw materials, in-process materials, finished products, or contact surfaces should wear clean clothing appropriate for the duties they perform and necessary protective apparel (for example, uniforms, gloves, safety glasses, and hair restraints).
|Raw materials must be identified, stored, examined, tested, inventoried, handled, and controlled to ensure they conform to appropriate standards and specifications. In particular, raw materials should be stored and handled to prevent mistakes (i.e., mix-ups or selection errors), contamination with microorganisms or other chemicals, and degradation from exposure to excessive environmental conditions (e.g., heat, cold, sunlight, moisture, etc.); held in closed containers and stored off the floor; maintained in containers that are labeled with the identity, lot number, and control status (release or quarantine); sampled and tested for conformance with specifications and to ensure the absence of filth, microorganisms, and other adulterants prior to processing or usage; properly identified and controlled to prevent the use of materials that fail to meet acceptance specifications.
|Laboratory controls must be in place to ensure that raw materials are tested for compliance with specifications, samples are representative of the lot, finished product samples and retained product samples are tested for microbial contamination, samples of approved lots of raw materials and finished products are retained for an adequate time period and stored under conditions that would enable re-testing, and returned cosmetics are examined for contamination and compliance with specifications.
|Internal Audits and Recalls
|Companies must have in place procedures for internal audits, management of complaints, adverse event investigation, and recalls.
The draft guidance also highlights the fact that certain ingredients are either prohibited or restricted from use in cosmetic products in the United States. These include bithionol, vinyl chloride, certain halogenated salicylanilides, zirconium in aerosol products, chloroform, methylene chloride, chlorofluorocarbon propellants, mercury compounds, and hexachlorophene.
Recent GMP Developments
The FDA is most likely going to refer to ISO 22716:2007 as the foundation of the cosmetic GMP regulation. Perhaps signaling its direction, on June 13, 2023, the FDA issued draft guidance on “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.” As part of this draft guidance, FDA provided the following on the subject of GMP requirements:
We also suggest examining and, where appropriate, establishing good manufacturing practices (GMPs) or applying GMPs that pertain to cosmetics generally (see, for example, International Organization for Standardization (ISO) standard pertaining to cosmetics, ISO 22716, titled “Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices” (Ref. 18)). We note that we intend to conduct rulemaking to establish good manufacturing practice regulations as part of the implementation of the Modernization of Cosmetics Regulation Act of 2022, which requires FDA to establish good manufacturing practice regulations that, to the extent practicable and appropriate, are consistent with national and international standards.
How Can You Get Involved in the Establishment of Final Binding GMPs?
As noted above, the GMP regulation implemented under MoCRA will be binding on the industry. The FDA will have the authority to inspect for compliance and conduct enforcement actions for noncompliance, including mandatory recalls. For this reason, it is essential for the industry at all levels to become involved in the GMP drafting process.
The FDA held its first public comment hearing pertaining to the GMP regulations on June 1, 2023. Namandjé N. Bumpus, Ph.D., Chief Scientist with the FDA provided the opening remarks, stressing that the FDA now has expanded regulatory authority and inviting public commentary to help develop the GMPs. Linda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors with the FDA, specifically invited stakeholders to comment on the following topics:
- Identification of national or international standards (ISO 22716:2007).
- What constitutes sufficient flexibility within GMPs for cosmetic products?
- What constitutes simplified GMPs?
- What are the appropriate GMP compliance deadlines?
- To what extent are manufacturers already following a national or international standard for GMP?
- What is the overall cost and economic impact of GMP compliance?
Various stakeholders have already weighed in as part of the public hearing. Among large and small businesses alike, there was a strong consensus that ISO 22716:2007 should be used as the foundation for any GMP regulation for cosmetic products. While small businesses expressed a concern that stringent GMP regulation could be financially burdensome, specifically regarding protocols surrounding isolated work areas, inspections, and personnel, larger corporations took the stance that consumers have an expectation of product safety, regardless of the size of a company.
Stakeholders also stressed that strong communication between FDA and industry is critical to the development and implementation of GMP regulations that are attainable and realistic. Many representatives further spoke to the need for international harmonization of the US GMP regulation its foreign counterparts to reduce the burdens related to international trade. For example, the FDA recently implemented updates to its medical device GMP regulations to more closely match the requirements of ISO 13485:2016, which is a commonly adopted international standard.
Finally, two consumer advocacy groups insisted on comprehensive requirements pertaining to raw material testing, specifically centered on talc. Such proscriptive testing requirements for raw materials are not common under the modern GMP schemes. A more flexible “purchasing controls” approach, where the finished product manufacturer establishes the necessary specifications and methods to ensure raw materials meet such specifications, is more common.
Comments to FDA’s draft GMP guidance are due by July 3, 2023, and many stakeholders are getting involved. Do not hesitate to reach out to your counsel to ensure that your perspective is represented in the development of the FDA’s binding GMP regulation.
Written with the assistance of Emily Loftis, a summer associate in the Husch Blackwell LLP Washington, DC office.