FDA

• Counseled clients on bringing products to market under FDA’s COVID-19-related Emergency Use Authorization framework and enforcement discretion policies.
• Counseled multiple clients on FDA and state requirements related to the inclusion of CBD in regulated products.
• Assisted client in preparation and submission of comments addressing FDA implementation of the Food Safety Modernization Act.
• Assisted multiple clients in assessing “new dietary ingredient” status of dietary supplement ingredients.
• Counseled client in preparation for FDA inspection of manufacturing facilities.
• Counseled client in handling cosmetic product customs detention.
• Submitted trade complaint regarding marketing of unapproved new drugs.
• Routinely provide comprehensive label review and regulatory compliance analysis.
• Represented drug company in submission of extensive comments addressing reimportation of prescription drugs.

FTC/NAD

• Successfully defended clients facing an FTC inquiry regarding advertising and promotional claims for antimicrobial products.
• Counsel clients on compliance issues related to advertising and promotion in mainstream media, online, and in social media.
• Successfully defended dietary supplement company’s advertising claims before the National Advertising Division (NAD) of the Better Business Bureau.

CPSC

• Routinely submit 15(b) filings with the CPSC and coordinate product recalls on behalf of consumer product companies and retailers.
• Successfully defended company against CPSC challenge regarding appropriate age-grading of consumer products.
• Advise multiple companies on compliance with the Consumer Product Safety Improvement Act of 2008 (CPSIA).

Transactional Work

• Represented numerous private equity funds in conducting regulatory due diligence on corporate transactions.
• Routinely conduct due diligence on FDA-regulated companies.