“Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products”

On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues — Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Toxic Substances Control Act (TSCA). The TSCA Inventory lists all chemical substances that may be manufactured or imported into the U.S. for TSCA purposes, and all chemicals in commerce must be on the TSCA Inventory or eligible for exemption. Intergeneric algae are reportable under TSCA, as well as spent biomass byproduct, depending on use. Algae and algal products have similar requirements to demonstrate safety under FFDCA, but this is done mainly through scientific studies as there is no list (or inventory) published by the U.S. Food and Drug Administration (FDA) of approved ingredients. Dr. Engler ended the presentation by emphasizing the need to understand regulatory burdens and seek assistance in preparation, review, and communication with regulators to bring a product to market. For a copy of this presentation, contact Dr. Engler at rengler@lawbc.com.