Cosmetics

Our FDA Lawyers Have Extensive Experience with Cosmetics

At MyFDALawyers.com, PC, our FDA cosmetics lawyers help companies navigate the full range of compliance issues, including the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). We are committed to helping you fix your FDA problems, ideally, before they ever arise in the first place. If you have any specific questions or concerns about cosmetic regulations, we are here to help. Contact our FDA attorneys today for a fully confidential consultation.

We Help Cosmetics Companies with Compliance Issues

The FDA attorneys at MyFDALawyers.com, PC have considerable experience working with companies in the cosmetics industry. We put a strong emphasis on proactive compliance. Notably, cosmetic products that are marketed in the United States must comply with several federal and state laws, including the Federal Food, Drug, and Cosmetic Act (FDCA), the Fair Packaging and Labeling Act (FPLA), and the recently enacted Modernization of Cosmetics Regulation Act of 2022 (MoCRA). We assist companies across the cosmetic industry in identifying and addressing regulatory risks before they become enforcement issues. Our services include:

• Labeling and Ingredient Declarations: We help clients ensure their product labels meet FDA requirements, including labeling claims, ingredient declarations, net quantity, and contract information for serious adverse events reporting. We also review ingredient safety.
• MoCRA Compliance: A recent reform to federal law, MoCRA introduced new mandatory requirements for cosmetic manufacturers, including facility registration, product listing, adverse event reporting, and safety substantiation. We guide companies through initial compliance and help maintain ongoing regulatory obligations under MoCRA.
• Product Classification: FDA will regulate a product marketed as a cosmetic as an unapproved (illegal) new drug if its claims suggest that the product can affect the structures or functions of the body. Among other things, our lawyers advise clients on the line between cosmetics and drugs to help avoid misbranding and unapproved drug enforcement actions.
• Claim Substantiation and Risk Mitigation: We review advertising and promotional materials for compliance with FDA and FTC standards. Our counsel focuses on helping companies make lawful, substantiated claims. Our team help you minimize your legal exposure.
• California Specific Compliance: We help companies with their California-specific compliance, including representation before the California Department of Public Health and guidance in compliance with the California Safe Cosmetics Program (CSCP) and the notorious California Proposition 65 (“Prop 65”).

An Overview of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

MoCRA is a big deal for the cosmetics industry. The law represents the first significant federal reform in cosmetics in decades. It added a robust regulatory framework for cosmetic products. For the first time, the FDA now has the clear and express statutory authority to mandate facility registration, product listing, and adverse event reporting for cosmetic manufacturers. Beyond that, MoCRA requires companies to maintain safety substantiation for each marketed cosmetic and to comply with new labeling requirements, including disclosure of fragrance allergens.

MoCRA introduces mandatory recall authority for the FDA when a cosmetic is deemed to present a serious adverse health risk, enhancing federal enforcement capabilities. The law also imposes new recordkeeping requirements and mandates Good Manufacturing Practice (GMP) compliance by all cosmetic manufacturers. A lot of changes have come to the industry, and more are coming, as FDA issues new regulations based on MoCRA.

California Safe Cosmetics Program (CSCP)

The California Safe Cosmetics Act requires companies selling cosmetics that contain certain potentially harmful ingredients to report their products and ingredients to the California Safe Cosmetics Program (CSCP). This requirement applies to any cosmetic being sold in California, regardless of where it is manufactured. The company named on the product is the one that must file reports.

The California Department of Public Health (CDPH) is like California’s own FDA. CDPH administers the CSCP and maintains a list of the affected ingredients. The list includes hundreds of potentially harmful chemicals, including ingredients listed in California’s Proposition 65 and fragrances and flavors identified by the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA).

MyFDALawyers is a California-based firm that can also assist companies in compliance with the California Safe Cosmetics Program (CSCP) and related regulations. ingredient review identifies ingredients that trigger the CSCP reporting requirements, as well as those that may require warnings under California Proposition 65.

How Our FDA Lawyers for Cosmetics Can Help

The FDA’s regulations for the cosmetics industry are notoriously complex. It is normal for businesses to have a lot of questions and concerns about their rights, responsibilities, and legal options. You do not have to navigate the regulatory and compliance process alone. Attorneys Bill Senior and Rick D. Quinn are FDA lawyers with decades of experience. When you reach out to our legal team, you will have an opportunity to consult with an FDA lawyer who can:

• Hear what you have to say and answer questions about FDA cosmetics law, regulations, and policy.
• Represent you before FDA and other regulatory agencies (e.g., CBP, CPSC, USDA, etc.).
• Handle all relevant regulatory requirements and enforcement actions, including inter-agency issues.
• Develop a strategy focused on helping your business best achieve its goals.