Quality within the consumer products industry has long been a strategic imperative for manufacturers of the world’s best brands. The cosmetics industry, however, has traditionally experienced significant autonomy when it comes to proving product efficacy and safety. Damaging headlines of late would suggest that lack of regulations have resulted in consumer-facing risks. It seems this is all about to change, as reported in a Wall Street Journal article.

With the backing of both the Personal Care Products Council and some of the industry’s largest players, proposals to expand the FDA’s governance over the industry are making bipartisan traction. A tentative agreement is expected to reach the Senate floor in coming months. If successful, new regulations would likely include the following:

• A requirement for cosmetics companies to register with the FDA
• A mandate to fully disclose any adverse reactions caused by products within 15 days
• Requirements to allow the FDA to evaluate a number of ingredients for safety

As with any expansion of industry regulations, complexities inherent in full compliance are expected to result. Manufacturers of all sizes are encouraged to take action now. Clarkston recommends considering the following:

• Would your organization benefit from learning about proven best-practices from the life science industry, an industry, long subjected to stringent FDA requirements?
• What steps can you take to “future-proof” your regulatory compliance strategy?
• Would an expansion of the FDA’s purview over your product lines expose blind spots in your compliance strategy?
• Have recent brand acquisitions left you with fractured quality practices that could be better harmonized?
• Is your organization prepared to correspond to regulatory agencies (specifically the FDA) at scale?
• Will gaps in data quality compromise your organization’s readiness to comply with new regulations?

Change is certainly fast approaching. It is not too early to develop a roadmap to proactively address changes in tomorrow’s regulatory environment and be a leader for quality in cosmetics.

Learn more about Clarkston’s Quality and Regulatory Services.