Digest

Main Content

Congress Presses FDA to Act on CBD Regulations

Following statements by the U.S. Food and Drug Administration that cannabidoil (CBD) in food and beverage products remains illegal, and amid the patchwork of state laws and enforcement actions, a group of U.S. lawmakers, led by Reps. Chellie Pingree (D-Maine) and James Comer (R-Ky.), have urged the FDA to “quickly adopt a policy of enforcement discretion and to consider issuing an interim final rule to regulate CBD as a dietary supplement and food additive while simultaneously moving forward with a robust framework for evaluating the safety and accurate labeling of these products.” The letter stated that the agency’s “current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry. We are discouraged by FDA’s estimation that a rulemaking process could span 3 to 5 years. We believe there are more expeditious measures that FDA could take that would establish regulatory

FTC Warns Companies Against Advertising CBD Products as Treating or Curing Diseases

The U.S. Federal Trade Commission has announced that it sent warning letters to three companies that sell “oils, tinctures, capsules, ‘gummies,’ and creams containing cannabidiol (CBD),” a chemical compound derived from the cannabis plant. The letters warn the companies, which have not been identified, that “it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.”

The FTC states that each company marketed its CBD products as being able to “treat or cure serious disease and health conditions,” such as relieving “’even the most agonizing pain’ better than prescription opioid painkillers,” or treating cancer, Alzheimer’s disease, multiple sclerosis (MS), fibromyalgia, cigarette addiction, colitis, schizophrenia, anxiety, depression, Lou Gehrig’s Disease (ALS), stroke, Parkinson’s disease, epilepsy, traumatic brain injuries, diabetes, Crohn’s disease, psoriasis, and AIDS.

In the letters, the FTC urges the companies to review all

Food Suppliers: Understand What Your Contamination and Recall Insurance Policies Do and Don’t Cover – Then Plan Accordingly

Last year saw a massive E. coli outbreak linked to romaine lettuce which left growers, packers and retailers struggling to identify root causes and assign liability – all while trying to protect end users from illness and injury.  To address the costs of contamination and recalls, food producers and manufacturers commonly obtain contamination insurance.  However, typical contamination policies cover only those losses incurred due to actual contamination, while arguably providing no coverage for recalls due to potential contamination.  A company that recalled its salads due to a risk that its romaine was contaminated with E. coli faces the likelihood that its insurer will claim the recall costs are not covered under the standard food contamination insurance policies – even though the recall was in the public’s best interest.  Food suppliers should evaluate whether there is a gap in their insurance coverage created by the limited language in certain contamination policies

California Prop. 65 Regulation Exempts Certain Coffee Chemicals From Cancer Warning; Stay in Coffee Case Lifted

June 26, 2019

Categories

California’s Office of Environmental Health Hazard Assessment (“OEHHA”) has finalized a highly anticipated Proposition 65 regulation relating to coffee. The regulation, California Code of Regulations Section 25704, takes effect October 1, 2019. Section 25704 provides: “Exposures to chemicals in coffee, listed on or before March 15, 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”

As we previously reported, OEHHA issued a notice of proposed rulemaking concerning the regulation in June 2018. The Office of Administrative Law approved adoption of the regulation on June 3, 2019, and OEHHA issued a Final Statement of Reasons on June 7.

OEHHA’s Final Statement of Reasons concludes that “the weight of the evidence from the very large number of studies in the scientific literature does not support

USDA and FDA to Jointly Regulate Cell-Cultured Food Products

March 11, 2019

Categories

The U.S. Department of Health and Human Services’ Food and Drug Administration (“FDA”) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) formally agreed on March 7 to share regulatory authority over cell-cultured meat products (“CCM”) derived from livestock or poultry.

As we previously reported, regulatory authority over CCM has been a much contested issue. FSIS purports to have jurisdiction over CCM under the Federal Meat Inspection Act (“FMIA”), while FDA purports to have jurisdiction under the Federal Food, Drug, and Cosmetic Act (“FFDCA”). Instead of battling over jurisdiction, the agencies have decided to collaborate – both will have oversight but at different stages of production. Essentially, FDA will oversee the initial stages of production, while FSIS will take on authority during cell harvesting.

While the details have yet to be refined, the agreement broadly allocates the agencies’ respective roles and responsibilities as follows:

Bioengineered Food Disclosure Rules Finalized, Require Disclosure of “Detectable” GMOs

On December 21, 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published its final rule implementing the National Bioengineered Food Disclosure Standard(NBFDS) signed into law by President Obama in 2016.   The NBFDS preempted state and local genetic engineering labeling requirements and charged AMS with developing a national mandatory standard for disclosing the presence of bioengineered (BE) food.  The rule takes effect on February 19, 2019, and implementation will be phased in over the next three years.

As we previously reported, the NBDS requires food manufacturers, importers of food labeled for retail sale in the U.S. and some U.S. retailers to disclose foods and ingredients produced from foods that are or may be bioengineered.  The final rule defines “bioengineered food” as any food that “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could