Drafting claims where you "walk the line" between cosmetic and drug claims is an art with little existing practical guidance. Although different experts can disagree about a particular claim, the labeling regulations are based on a strong regulatory foundation. After a discussion of pertinent U.S. laws and regulations, we extensively examine actual claims and determine whether they cross the line We will each examine claims to better understand the cosmetic/cosmeceutical interface. It will be fast paced but fun! Then, you will have a chance to ask questions about the presentation and related issues. By the end of the presentation, you will be more able to develop cosmetic claims with a lower regulatory risk.
Why you should attend: Cosmetic manufacturers are driven by the need to have product claims that are at least as strong as their competitors. At the same time, they are rightfully concerned that if they cross the line and make a drug claim, they may be subject to the misbranding provisions of the Act, which can lead to product seizure, injunction and criminal action against companies or its responsible people. You will learn who is watching over you when you develop claims and how to reduce your regulatory risks.
Areas Covered In the Seminar: - How to distinguish between illegal and legal claims
- What makes a claim a cosmetic claim or a drug claim
- Which claims are lower risk than others and why.
- What is the meaning of Intended Use
- Misbranding
- False and Misleading
- The OTC Monograph
- The role of the FDA, Federal Trade Commission (FTC) and other regulatory and non-regulatory bodies can have in reviewing your claims
- Internet promotion
- Claims at trade shows
- What are the risks on non-compliance
- Warning Letters
- FTC Actions
- Minimizing problems in drafting claims.
