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U.S. FDA Relaxes Menu and Nutrition Facts Labeling Requirements in Response to Pandemic

April 9, 2020


In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has temporarily relaxed some of its requirements concerning menu and nutrition labeling, and extended certain enforcement deadlines.

Menu Labeling

The FDA has announced that it “will not object” if, during this public health emergency, restaurants and retail food establishments do not meet menu labeling requirements requiring disclosure of calories and other nutritional information.

The FDA regulations  typically apply to restaurants and similar retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items.

The FDA stated that this policy is intended to provide flexibility to restaurants and food establishments that may have to rapidly transition to take-out only or that are experiencing disruptions in their supply chains requiring substitutions. To provide further guidance, it

FDA and FTC Warn Against Making Unapproved COVID-19 Claims

April 8, 2020


FDA and FTC Warn Against Making Unapproved COVID-19 Claims

April 8, 2020

Authored by: BCLP Digest

In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel coronavirus. This follows the seven warning letters jointly issued by the agencies in early March.

  • Gaia’s Whole Healing Essentials LLC was warned for selling colloidal silver products with claims that the products can build immunity and possess anti-viral properties for the treatment or prevention of COVID-19.
  • Homeomart Indibuy was warned for claiming that its homeopathic drug products treat respiratory illnesses and act as a prophylactic to protect from COVID-19 infection.
  • Health Mastery Systems DBA Pure Plant Essentials was warned for selling essential oils with claims that the products are safe and/or effective for the treatment or prevention of COVID-19. In addition to identifying improper claims made on the manufacturer’s website, the warning letter also

Year in Review: 2019 Food, Beverage and Supplement Litigation Roundup

2019 was another active year for new regulatory activity and litigation targeting the food, beverage, and supplement industries.

In this roundup, Bryan Cave Leighton Paisner LLP presents a collection of regulatory developments, key court decisions, and notable settlements that were reached in 2019 and early 2020.

The highlights of this 2019 roundup include:

  • New federal legislation governing food labeling.
  • New regulations and a burst of litigation regarding CBD-based products.
  • An update on slack fill litigation.
  • Notable rulings, trials, and settlements.
  • Prop 65 and food safety update.
  • A preview of areas to watch in 2020.

FDA Issues Guidance on Alcohol-Based Hand Sanitizer Production in Response to COVID-19

March 27, 2020


In response to the outbreak of COVID-19, the Food and Drug Administration (“FDA”) has issued guidance for industry that will temporarily expand manufacturers’ ability to legally produce and sell alcohol-based hand sanitizer.  These new measures are intended to address a shortage of alcohol-based hand sanitizer products, as well as reports that consumers have attempted to produce hand sanitizer for their own personal use, which raises serious safety concerns.  This Alert summarizes the latest guidance and provides takeaways for consideration.

1. Policy for Temporary Compounding of Certain Alcohol Based Hand Sanitizer Products During the Public Health Emergency (March 2020).

The first guidance to issue is specifically directed at pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities, which the FDA describes collectively as “compounders.”

Compounding is a practice in which a licensed pharmacist, physician, or, in the case of an outsourcing facility, a person under the supervision of a

COVID-19: FDA and USDA Guidance on Worker Safety and Sanitation in Food Production Facilities

March 26, 2020


As the COVID-19 pandemic has continued to escalate, both the Food and Drug Administration (“FDA”) and the U.S. Department of Agriculture (“USDA”) have issued guidance and public statements advising manufacturers and distributors in the food and agriculture industry how best to maintain worker safety and sanitation in food production facilities.

In sum, both the FDA and USDA currently emphasize that foodborne exposure is not known to be a route of transmission of COVID-19 and defer to local rules and pre-established guidelines with regards to maintaining clean food facilities.  Below are highlights from FDA and USDA on worker safety and sanitation in food production facilities in light of the coronavirus pandemic:

A. Overview:

  • “Food facilities, like other work establishments, need to follow protocols set by local and state health departments, which may vary depending on the amount of community spread of COVID-19 in a particular area.” – USDA.
  • “We do

FDA Extends Enforcement of New Nutrition Facts Label Another 6 Months

Although January 1, 2020 was the deadline for many companies to implement the new Nutrition Facts label, the FDA states on its Industry Resources on the Changes to the Nutrition Facts Label web page that it will not take any enforcement actions for the first six months, or until after July 1, 2020.

The FDA initially set a general compliance date of July 2018. Manufacturers with annual food sales of less than $10 million were given an additional year to comply. In May 2018, the FDA extended those compliance dates “by approximately 1.5 years.”

The FDA has provided the following example illustrating what’s different about the new Nutrition Facts label:

Importantly, the new label requires:

  • Declarations for “added sugars” in grams and as a percentage of Daily Value
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