Cosmetic Regulatory Consulting
The importation, manufacture and distribution of cosmetics in the United States are booming and the industry has enjoyed a fairly open and flexible regulatory climate over the last few decades. Americans are using more and more cosmetic products each year and the opportunities are only increasing for companies entering the U.S. marketplace. Recent trends in both government legislation and popular culture, however, have led to increased scrutiny of cosmetics, especially with ingredient safety and labeling. Recently, a government panel considered testimony from the industry, FDA and consumers regarding the development of new cosmetic legislation covering everything from user-fees and facility registration to labeling guidelines. U.S. FDA’s attention is more and more focused on cosmetics and all tolerance for labeling violations will rapidly diminish. The time is now for cosmetic companies to get compliant and prepare for increased scrutiny.
The U.S. Food and Drug Administration have the legal/regulatory authority over cosmetics. JAD provides solutions to foreign & domestic companies that want to market their cosmetics into the United States. If the cosmetic is manufactured in the U.S. or imported from abroad the product must be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the Fair Packaging and Labeling Act (FP&L Act)
The Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), which prohibit the marketing of adulterated or misbranded cosmetics: If a cosmetic product is deemed misbranded or adulterated, or if a cosmetic firm fails to comply with safety regulations, then FDA may pursue enforcement action against products or firms that violate the law.
Medical claims made about a cosmetic, whether in advertising or labeling, is the major difference whether the product is regulated by FDA as a drug or cosmetic- or can listed as both by the U.S. FDA.
JAD offer consulting solutions for your company cosmetic or personal care products. Our subject matter experts will provide your company with a variety of product issues that may be encountered, including:
- FDA Cosmetic Product Ingredient Statements (CPIS) filing
- Preparing safety assessments for ingredients
- Advising on product claims, ingredient listings and warning declarations
- Reporting adverse events
- Reviewing scientific studies, data and information to substantiate product claims and establish ingredient safety.
- Providing import/export advice
- Advising on compliant labeling and advertising strategies
- Responding to concerns regarding a company’s product
- Providing guidance on compliance issues relating to cGMPs, record keeping, product recalls, market withdrawals and FDA inspections
- Evaluating the safety of cosmetic ingredients
- Reviewing cosmetic labeling for compliance with FDA requirements
- Preparing color additive petitions for submission to FDA for approval
- Assistance in registering products in the Voluntary Cosmetic Registration Program
- Advising on safety and environmental issues associated with the use of nanotechnology.