1. What to do upfront to prevent trouble What to do when “stuff” happens

2. An Ounce of Prevention Who: Start by understanding all the different regulatory bodies that affect marketing a product: FDA, FTC, NAD, EPA, DOT…. And don’t forget the states… Who #2: Consider which Retailers, watchdog groups, bounty hunters, non-profits and social media channels are in play What: Claims and where you make them need to drive the development and testing process. What #2: Look for trends in enforcement actions to understand where agencies are focusing their efforts When: Get continuous feedback from the beginning Why: Strive to understand the spirit of the regulation How: Find reliable sources to sort through all the regulations and provide you updates. Personal Care Council, Fragrance houses and Chemical vendors, SCC are all good places to start. PARTICIPATE!

3. A Pound of Cure Identify a quarterback to manage the issue and assemble a focused team to provide a recommendation Get the right legal counsel up front The Brand needs to be everyone’s priority – not their career. Don’t look for blame – you need to encourage absolute truth as fast as possible. The truth will come out. Communicate the plan to the organization and provide guidance on how to bring info forward. Identify external resources to contact regulatory body to float ideas through without identifying your company Keep Sales management and PR/consumer response teams in the loop.

4. Some questions to ask yourself  An government inspector shows up at your business. Do you have people trained to deal with the situation?  If you formulate through contract manufacturers, do they have the regulatory understanding necessary?  No matter who makes your product, the company marketing and selling a product is liable for compliance. Do you have someone internally who manages that?  Has your system ever been tested? Do you audit it or run surprise mock audits?  Is it clear who has the authority to make decisions if you have a regulatory or safety issue?

5. Contact me if you want some help Don Frey donaldhfrey@gmail.com 310-801-8200