Cosmetics, OTC Drugs & Personal Care Products
We counsel clients on regulatory compliance related to product development, formulation, and positioning, ingredient safety, claims substantiation, federal and state labeling requirements, and advertising of cosmetics, OTC drugs, and personal care products, including drug/cosmetic combination products such as sunscreens, oral care products, skin protectants, skin sanitizers, and anti-acne products. We also assist companies with post-marketing issues, including inspections, recalls, import detentions, and responding to adverse product information.
Our attorneys participate in agency rulemaking, respond to federal and state enforcement actions, handle civil and criminal litigation, and guide clients through interpreting and complying with the Federal Food, Drug, and Cosmetic Act, the Federal Fair Packaging and Labeling Act, Federal Trade Commission Act, and related statutes and regulations.
How We Help
Some of our frequent FDA regulatory work includes:
- Advising our clients on OTC/cosmetic product formulations, color additives, manufacturing compliance, product claims, ingredient safety/nomenclature, and related regulatory issues
- Representing clients before FDA and US Customs on product detentions at US Ports of Entry
- Managing issues related to product adulteration and misbranding, recalls, market withdrawals, and stock recoveries
- Navigating the regulation of cosmetic beauty appliances, including manual and powered appliances (e.g., electrical, radio frequency, and ultrasound)
- Counseling clients before, during, and after FDA facility inspections, preparing and reviewing standard operating procedures, and advising on state disclosure laws, such as the California Safe Cosmetics Act and Proposition 65
Advertising and Promotion
The FDA, Department of Justice, FTC, Council Better Business Bureau’s National Advertising Division, state attorneys general, and other agencies are increasingly taking cosmetics, personal care product, and OTC drug companies to task for advertising and promotion practices deemed or suspected of being false, misleading, or otherwise unlawful.
Our experienced regulatory attorneys employ a deep understanding of the industry to help our clients preemptively address these issues, drawing on our knowledge of businesses’ and regulators’ interests to provide practical, sophisticated solutions that address competing demands to achieve clients’ strategic goals. Together with Arent Fox’s bench of experienced litigators, we defend our clients’ business interests at all stages of dispute resolution by:
- Providing regulatory counseling designed to avoid and mitigate litigation risks
- Assessing substantiation for product claims
- Defending threatened enforcement actions or competitor or class action challenges
- Investigating and challenging competitors’ unlawful promotional practices
Proposition 65 and Consumer Product Safety Commission (CPSC)
Arent Fox represents a number of cosmetics, personal care products, and OTC drug companies on a wide range of regulatory and product safety issues. We have also worked with a number of our clients on the unique issues presented by Proposition 65 in the state of California.
Our work includes:
- Counseling clients on the scientific and technical aspects of consumer product safety, including potential recalls and ingredient or component toxicity
- Advising on compliance and defending businesses in notices of violations across an array of product lines and chemical compositions
- Helping clients navigate CPSC’s requirements, advising on issues related to product development and marketing compliance, such as product defects and reporting obligations, and assisting in recalling products in the event of health or safety issues
- Helping manufacturers and sellers of various consumer products develop and enhance Prop 65 compliance programs, as well as assisting in the complexities and nuances of Prop 65- and product-related pre-litigation and litigation
- Participating in Prop 65 investigations into toxicity of components of personal care products, powdered cosmetics, antibacterial soap, external analgesic, and anti-aging skin treatments
Cannabis & Cannabidiol (CBD)
Cannabis-derived ingredients like CBD and hemp seed oil are one of the biggest trends in the cosmetics industry today. As the cannabis industry grows, regulatory oversight by the FDA, FTC, US Department of Agriculture, and Drug Enforcement Administration, as well as their state counterparts, is ever-changing and often uncertain.
We help clients navigate the intricate and constantly changing web of legal, regulatory, and business issues that occur during development, manufacture, distribution, and sale of products with cannabis-derived ingredients, such as:
- Tracking and advising clients on federal and state developments in this industry
- Counseling on product labeling, advertising, marketing regulations, and more