FDA Cosmetics Compliance
Experienced Federal Compliance Lawyers and Former FDA Personnel Representing Cosmetics Companies in the U.S. and Worldwide
FDA Cosmetics Compliance Team Lead
FDA Cosmetics Compliance Team Lead
Former DOJ Attorney
FDA Cosmetics Compliance Team Lead
Former Senior DOJ Trial Attorney
The U.S. Food and Drug Administration (FDA) regulates the manufacture and sale of cosmetics products in the United States to prevent serious adverse events related to the products under its jurisdiction. Its regulatory authority extends to manufacturers, importers, exporters, distributors, and other companies involved in all aspects of the cosmetics industry, and noncompliance with the FDA’s requirements can lead to recalls, fines, and other penalties.
We assist companies in the U.S. and around the globe with FDA cosmetics compliance. The FDA has implemented several new laws and regulations in recent years, and these new laws and regulations add significantly to companies’ compliance burdens. The most significant of these is the Modernization of Cosmetics Regulation Act of 2022 (or “MoCRA”), which—in addition to requiring compliance with Good Manufacturing Practices (GMP)—establishes new ingredient disclosure, product listing, substantiation, registration, and adverse event reporting compliance requirements.
FDA Cosmetics Compliance: What Manufacturers and Other Companies Need to Know
Unlike certain other FDA-regulated products, cosmetics are not subject to FDA pre-approval. While manufacturers and other companies must meet various other legal and regulatory requirements, they do not need to go through the pre-market submission process that applies to things like drugs and medical devices. As the FDA explains:
“The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.”
However, under MoCRA, other pre-market requirements now apply. The most significant of these include:
- Facility Registration for Cosmetics Manufacturers and Processors: “Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.”
- Cosmetic Product Listing with the FDA: “A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.”
As noted in these quotes from the FDA, along with meeting the FDA’s pre-market requirements, cosmetics companies must meet various ongoing reporting and listing requirements as well. And, again, these represent just one segment of FDA cosmetics compliance. Other key areas of FDA compliance for cosmetics manufacturers, processors, and other companies include:
- Cosmetics Safety and Labeling: While the FDA has not established any specific labeling requirements for individual types of cosmetic products, it prohibits “the marketing of adulterated or misbranded cosmetics in interstate commerce.” As a result, companies must be extremely careful not only to ensure that their products are safe (including that they are unadulterated), but also to ensure that their labels accurately reflect their products’ ingredients, benefits, and risks.
- Substantiation: While the FDA does not require that cosmetics undergo specific tests or require cosmetic companies to share their safety data, it does require cosmetics companies to substantiate their safety determinations. To substantiate their safety claims, companies must conduct testing that is appropriate in light of the nature of each specific product and the potential risks it presents. If they experience a serious adverse event with a product, they must report such an event within 15 days.
- Ingredient Restrictions and Warnings: As the FDA states, “regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.” Cosmetics companies must strictly comply with these prohibitions, restrictions, and requirements in order to avoid unnecessary and high-risk scrutiny from the FDA.
- FDA Inspections and Product Sampling: The FDA has the authority to inspect cosmetic manufacturing facilities, “to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded.” These inspections can present substantial risks, and manufacturers must work closely with their FDA cosmetics compliance counsel to ensure that they are prepared.
- Recalls and Safety Alerts: While the FDA does not have the authority to issue mandatory recalls in the cosmetics industry, it can request recalls, and it can pursue enforcement action when companies continue to sell products that the FDA has classified as adulterated or misbranded. When companies uncover safety risks through their own internal compliance monitoring, market surveillance, or receipt of consumer complaints, they may need to issue voluntary recalls or safety alerts (or update their product labeling) to mitigate their compliance risk and reestablish FDA compliance.
Additionally, as the FDA notes, if a cosmetic product “is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug . . . or in some cases a medical device,” and “‘personal care products’ may be regulated as dietary supplements or as consumer products.” These classifications trigger additional FDA compliance obligations—including pre-market submission obligations in some cases. Cosmetics that contain color additives may be subject to pre-market submission requirements as well, even if they do not qualify as a drug or medical device.
Our FDA Cosmetics Compliance Services
Our FDA cosmetics compliance services are designed to help manufacturers, processors, distributors, and other companies manage cost-effective compliance programs on an ongoing basis. These services include:
FDA Compliance Program Development (Policies and Procedures)
Our FDA compliance lawyers draft custom-tailored policies and procedures that address our clients’ specific compliance obligations and that are designed to facilitate effective implementation in light of their specific operational needs and constraints.
FDA Compliance Program Training and Implementation
Our lawyers and consultants conduct FDA compliance program training sessions for relevant personnel. We also assist with all other aspects of compliance program implementation, from developing new testing protocols to establishing appropriate checks to ensure labeling compliance.
Safety, Substantiation, and Labeling Compliance
We advise our clients on all aspects of safety, substantiation, and labeling compliance. While we serve as outside general counsel to advise many of our clients on these issues on an ongoing basis, we are available to provide advice on an as-needed basis as well.
Ongoing FDA Compliance Management, Monitoring, and Enforcement
Effectively managing FDA compliance requires careful attention to companies’ legal and regulatory obligations on an ongoing basis. We help our clients implement effective protocols for internal monitoring and enforcement or perform these functions on behalf of our clients, as desired.
Event Response (Including Response to FDA Inquiries)
Our lawyers and consultants are also available to assist our clients with event response. This includes, but is not limited to, responding to FDA inquiries. In most cases, a prompt and proactive response to potential issues and risks will help to facilitate the most favorable and cost-effective outcome.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
FAQs: Understanding the Challenges (and Risks) of FDA Cosmetics Compliance
Do All Cosmetics Companies Need to Address FDA Compliance?
Yes, essentially all companies involved in the cosmetics industry need to address FDA compliance. From large corporate manufacturers and distributors to small businesses that sell boutique and hand-crafted products, the FDA’s enforcement jurisdiction within the cosmetics industry is extremely broad. While exceptions and exemptions apply in some cases, company owners and executives need to ensure that they are making informed decisions about FDA cosmetics compliance.
What Cosmetics Companies Are Exempt from FDA Compliance?
Under MoCRA, certain small businesses are exempt from the FDA’s facility registration and product listing requirements. However, these businesses may still need to address other aspects of FDA compliance, including (but not limited to) the product testing and labeling requirements that apply to cosmetics generally. Additionally, the small business exemptions under MoCRA do not apply to companies that manufacture the following types of cosmetic products:
- “Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.”
- “Products that are injected.”
- “Products that are intended for internal use.”
- “Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.”
What Are the Penalties for Selling Cosmetics that Are Not FDA-Compliant?
The penalties for selling cosmetics that are not FDA-compliant can be substantial. When warranted, the FDA works with the U.S. Department of Justice to “pursue action . . . in the federal court system to remove adulterated and misbranded cosmetics from the market.” Enforcement actions targeting cosmetics companies can lead to fines, injunctions, and other penalties as well.
Is It Safe to Work with an FDA Cosmetics Compliance Service?
There are several companies that offer FDA cosmetics compliance services and promise things like “fast regulatory approval.” Unfortunately, working with these companies can be risky. FDA cosmetics compliance is extremely complex and product-specific, and any mistakes or oversights can put companies at risk for swift enforcement action. As a result, in the vast majority of circumstances, cosmetics manufacturers, distributors, and others in the industry will be better off engaging an FDA compliance law firm to assist them with developing and implementing a custom-tailored compliance program.
How Can I Ensure that My Cosmetics Company is FDA-Compliant?
At Oberheiden P.C., we work with companies of all sizes and in all segments of the cosmetics industry to help them establish and maintain FDA compliance. Our lawyers and consultants can explain everything you need to know, and we can work with you to develop an FDA cosmetics compliance program that is custom-tailored to your company’s specific needs.
Schedule a Complimentary Consultation with an FDA Cosmetics Compliance Lawyer at Oberheiden P.C.
To learn more about our FDA compliance services for companies in the cosmetics industry, contact us today. Call 888-680-1745 or get in touch online to schedule a complimentary consultation at Oberheiden P.C.
