Companies regulated by the Food and Drug Administration (FDA) understand that qualified strategic advisors are critical to their success. The Greenspoon Marder FDA practice provides comprehensive legal services to companies subject to the Federal Food, Drug, and Cosmetic Act (FDCA), the Public Health Service Act, the Food Safety Modernization Act (FSMA) and the Dietary Supplement Health and Education Act (DSHEA) and related federal and state laws. Our team is extremely well connected to FDA legislative initiatives and counsels clients across the nation regarding advocacy advice on FDA policy, legislative matters and governmental affairs.
We support clients through the regulatory life cycle of their products including food, pet/animal food, ingredients and food contact/packaging. We work with risk assessment experts, scientists and technical advisors for an integrated solution.
Greenspoon Marder attorneys can help with:
- Research and commercial agreements
- GRAS and NDI ingredients
- FSMA compliance
- FDA-enforcement action
- Manufacturing compliance (GMPs)
- Post-market compliance counseling
- Pre-market approval and clearance strategies
- Product labeling, advertising and promotional approaches
We work in varied industries across the nation with businesses including:
- Researchers & Developers
- Trade Associations
- Medical Centers & Health Care Providers
- Vendors and Independent Contractors
- Non-Profit and Patient Advocacy Organizations
On December 20, 2018 the President signed the Agriculture Improvement Act of 2018 (“Farm Bill”). This law is groundbreaking because it removes hemp (containing less than .3% THC) from the purview of the Controlled Substances Act. The FDA will now have an expanded role in regulating these products– including CBD – will be subject to the same regulations and requirements as other non-cannabis FDA-regulated products.
As the industry navigates and creates this “new normal” regulatory environment, it is more important than ever to have experienced legal advisors on your team.