The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak.

The FDA issued two guidance documents to increase the supply of alcohol-based hand sanitizers. The first indicates that FDA will

Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19).  At the time of this writing, FDA has not offered specific recommendations on measures that regulated industries should take.  However, good manufacturing practice (“GMP”) requirements and the Federal Food, Drug and Cosmetic Act (“FDCA”) impose obligations on regulated industry to monitor and control employee health and sanitation practices as they relate to product quality and safety.  Beyond the risk of state and federal enforcement, there are reputational risks associated with inadequate management of COVID-19.

Continue Reading Coronavirus in FDA-Regulated Industries

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

Continue Reading FDA States CBD Is Not GRAS for Use in Food, Issues More Warning Letters

The U.S. Food and Drug Administration (FDA) recently announced it will hold a public meeting on October 21, 2019 to discuss the “New Era of Food Safety.” FDA is exploring new and emerging technology to assess risks and prioritize resources, while creating a digital, traceable, and safer system. The agency’s initial focus areas are traceability, smarter tools and approaches for prevention, the challenges of new business models and retail food safety, and support for the development of food safety cultures.

Continue Reading FDA Announced Public Meeting on New Era of Food Safety

The Federal Trade Commission (FTC) sent Warning Letters to three companies that sell products containing cannabidiol (CBD) and advertise that the products prevent, treat, or cure disease without substantiation of the purported health benefits.  The products covered by these warnings letters were oils, tinctures, gummies, and dietary supplements.

Continue Reading FTC Issues Warning Letters to Three CBD Companies

Today, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would require health warnings on cigarette packages and advertising.  The warnings include color images depicting some of the lesser-known health risks of cigarette smoking.  This is FDA’s second attempt to require graphic warnings for cigarette packages and advertisements.

Continue Reading FDA Proposes New Health Warning for Cigarette Packages and Advertisements

We are approximately nine months into FDA’s animal feed and pet food facility inspections for compliance with the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food (PC) rule. With PC inspections starting for small businesses this Fall, there are a few lessons we have learned from the inspections that have occurred to date.

Continue Reading Is Your Animal Food Safety Plan up to Snuff?

Today, the U.S. Food and Drug Administration held a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). The public hearing was intended to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis and cannabis-derived compounds. Along with holding the public meeting, FDA is accepting written comments through a docket on those topics until July 1, 2019. 
Continue Reading At Public Meeting, FDA Requests Data on Dosage and Delivery Formats of CBD and Other Cannabis-Derived Compounds