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FDA

Plan Coverage of At-Home COVID-19 Testing

January 12, 2022 by Patrick Quinn

The Bottom Line Effective January 15, 2022, plan coverage of FDA-approved over-the-counter at-home COVID-19 diagnostic tests is mandatory. Plan sponsors should immediately contact their pharmacy benefit managers to set up mechanisms for direct coverage of at-home tests.If any questions Continue Reading

Alert - January 12, 2022

New California CBD Law Highlights the Federal / State Regulatory Divide

October 4, 2021 by Catherine Nagle

The Bottom Line Assembly Bill 45 in California now permits food and dietary supplement products to include CBD.The differing approaches by the California and federal governments highlights the complicated regulatory environment for ingestible CBD products.Brands, agencies and media companies Continue Reading

Alert, Balancing Compliance and Creativity in Regulated Industries - October 4, 2021

Navigating High Stakes Issues in a Budding Industry

October 6, 2020 by Patrick Quinn

7th Edition: Trends in Marketing Communications Law Last year was a watershed moment for the cannabis and hemp industries. And despite the widespread impacts of COVID-19 on the U.S. economy, if those developments are any indication, the years ahead will bring significant changes to the burgeoning Continue Reading

Trends in Marketing Communications Law - October 6, 2020

How “Natural” Is That Cosmetic? Legislators May Decide.

October 6, 2020 by Patrick Quinn

7th Edition: Trends in Marketing Communications Law Consumers are becoming increasingly savvy, even as the retail landscape is constantly evolving with new categories and sub-categories. In the cosmetics space, new independent brands have joined an already crowded field, while established Continue Reading

Trends in Marketing Communications Law - October 6, 2020

The FDA Sends Over 60 Warning Letters to Companies for Falsely Marketing “COVID-19 Products”

June 10, 2020 by Patrick Quinn

The Bottom Line Marketers and affiliate marketers of supplements, oils and similar products regulated by the FDA must be extremely cautious about referring to COVID-19 or its symptoms in marketing communications about such products. Statements that might otherwise be acceptable will likely be Continue Reading

Alert, Demystifying COVID-19 Complexities and Thriving in Uncertain Times - June 10, 2020

FTC and FDA Fight Unsubstantiated Claims That CBD Products Cure Coronavirus

May 6, 2020 by Patrick Quinn

The Bottom Line Consumer protection regulators are taking the COVID-19 crisis very seriously.The FTC and FDA have both stepped up enforcement actions against companies making unsubstantiated claims that CBD products may help combat the disease.The FDA has issued numerous emergency warning letters Continue Reading

Alert, Demystifying COVID-19 Complexities and Thriving in Uncertain Times - May 6, 2020

FDA Provides Temporary Flexibility on Nutrition Labeling in Response to the COVID-19 Pandemic

April 6, 2020 by Patrick Quinn

The Bottom Line In order to maximize food distribution and offset losses caused by disruptions to the food industry, the FDA issued guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 Continue Reading

Alert, Demystifying COVID-19 Complexities and Thriving in Uncertain Times - April 6, 2020

The Newest Ingredients in Cosmetics: CBD and Probiotics

July 10, 2019 by Patrick Quinn

6th Edition: Trends in Marketing Communications Law Cannabidiol (CBD) appears to be everywhere lately — available as an additive in certain food and drink products, as an oil meant to be used as a dietary supplement and even in cosmetics. But despite the widespread popularity and excitement over Continue Reading

Trends in Marketing Communications Law - July 10, 2019

FDA Public Hearing on the Use of Cannabis and Cannabis-Derived Compounds in Food and Dietary Supplements

June 3, 2019 by Anita Mitchell

The Bottom Line The FDA is in uncharted territory and has requested additional safety data to assess whether CBD and other cannabis-derived compounds can be safely added to food and dietary supplements.The industry believes that CBD has the potential for significant health benefits, but is open Continue Reading

Alert - June 3, 2019

FTC and FDA Target Advertising of CBD Health Claims

May 17, 2019 by Megan O'Malley

The Bottom Line The legalization of hemp is a major step in establishing a potentially significant new industry. However, producers and marketers need to exercise caution when making health-related claims in connection with hemp-based product. The FTC and FDA will continue to aggressively review Continue Reading

Alert - May 17, 2019

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