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With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics.

On January 21, 2021 at 3:00 PM in Eastern Time, the Centers for Disease Control and Prevention (CDC) will host a joint webinar to provide updates on COVID-19 vaccine implementation for food and agriculture essential workers. The webinar will also cover vaccine safety and confidence as well as recommendations for vaccine prioritization.

The panelists for

On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted over an approximate one year period for undeclared allergen(s).  FDA reported that investigators found similar patterns of recalls in previous years.  According to a Constituent Update accompanying the Warning Letter, FDA has sent eight Warning Letters to companies that have manufactured and distributed foods with undeclared allergens in 2020.

This Warning Letter is significant because it is the first time that FDA has issued a Warning Letter to a retailer for the labeling of allergens.  According to FDA, its action was warranted because the company allegedly “engaged in a pattern of receiving and offering for sale misbranded food products” that contained undeclared allergens over multiple years.  While retail establishments are excluded from certain requirements under the Federal Food Drug and Cosmetic Act, retailers have a responsibility to ensure that food labeled within a store contain accurate allergen declarations as well as have a responsibility to ensure packaged foods under the retailer’s brand also have accurate allergen declarations.  The Warning Letter highlights that a retailer is “responsible for investigating and determining the causes of the violations . . . and for preventing their recurrence or the occurrence of other violations. It is [a retailer’s] responsibility to ensure [the] firm complies with all requirements of federal law and implementing regulations” including when products are relabeled in store.

Over half of the FDA’s 338 recalls in 2020 were associated with allergen labeling issues, according to an analysis by the Food Industry Association.  The FDA considers foods that contain undisclosed allergens as adulterated, and has the authority to take enforcement actions with respect to such products – unless the offending company voluntarily recalls those products first.  With this Warning Letter, FDA is suggesting that food retailers have the responsibility to take proactive steps to ensure food is appropriately labeled for allergens when consumer labeling occurs in store.
Continue Reading FDA Reiterates Importance of Allergen Labeling by Issuing Warning Letter Following Repeated Recalls

On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program.  That user fee program was an addition made in the Coronavirus Aid, Relief, and Economic Security (CARES) Act and authorized FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests.

These user fees concern over-the-counter (OTC) monograph drugs, which are nonprescription drugs without an approved new drug application which are governed by the provisions of section 505G of the Federal Food Drug and Cosmetic Act (21 U.S.C. 355h).  Under the new fee schedule, FDA will assess a fee for certain facilities registered with FDA and for the submission of an OTC monograph order request (OMOR).  An OMOR is an industry request for an administrative order to add, remove, or change an OTC drug monograph, which is submitted under section 505G(b)(5) of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 355h(b)(5)).

The announcement took some by surprise, particularly those in the craft distilling industry that shifted production to FDA regulated hand sanitizers, a type of OTC monograph drug, during the COVID-19 public health emergency.  By December 31, 2020, the Department of Health and Human Services (HHS) took action over FDA’s fee schedule.  In a post on Twitter, the HHS Chief of Staff, citing the small businesses who stepped up to provide hand sanitizer in the face of the pandemic, announced that HHS had “directed FDA to cease enforcement of these arbitrary, surprise user fees.”  HHS Office of Public Affairs (Dec. 31, 2020), at https://twitter.com/SpoxHHS/status/1344782160084037639.
Continue Reading Holiday Confusion for the Over-the-Counter Drug Industry: FDA Announces OTC Fee Schedule That HHS Quickly Withdraws

Last week, the U.S. Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) issued a checklist to assist human and animal food operations during the COVID-19 public health emergency. The checklist is useful for persons growing, harvesting, packing, manufacturing, processing or holding human and animal food regulated by FDA when assessing or

The U.S. Food and Drug Administration issued a final rule, effective October 13, 2020, to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that are labeled “gluten-free.”
Continue Reading FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented or Hydrolyzed Ingredients

The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) has proposed to amend the organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. This is one of the largest overhauls since the National Organic Program (NOP) was established.
Continue Reading USDA’s Proposed Rules on Organic Enforcement

On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend the Proposition 65 regulations. Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide “clear and reasonable” warnings before knowingly and intentionally exposing Californians to listed chemicals. These warnings are required to appear on a wide range of products, including foods.
Continue Reading California’s OEHHA Proposes Regulation Requiring Warning for Acrylamide in Food

Recently, the Centers for Disease Control (CDC) and Occupational Safety and Health Administration (OSHA) jointly issued an interim guidance to meat and poultry processing companies to facilitate continued operations and mitigate the risk of spreading COVID-19.  This interim guidance document marks the first time the federal government has issued comprehensive recommendations to a specific industry on safe operation of a facility during the COVID-19 public health emergency.
Continue Reading CDC issues Guidance for Meat and Poultry Processors with OSHA, President Issues Executive Order to Reopen Facilities

The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency.  In March, FDA announced that it was temporarily suspending routine inspections of domestic and foreign facilities, except “mission critical” inspections, as well as conducting remote inspections of food importers subject to the Foreign Supplier Verification Programs.  FDA intends to continue suspending routine inspections for the time being and states that it will resume those inspections when local, national, and international conditions warrant.
Continue Reading FDA Provides Updated Plan on Inspections During COVID-19

The U.S. Food and Drug Administration (FDA) and Alcohol and Tobacco Tax and Trade Bureau (TTB) have issued new and updated guidance documents in addition to those previously published in order to address the decreased market supply of hand sanitizer products resulting from the rapid spread of the COVID-19 pandemic.
Continue Reading FDA and TTB Issue Additional Guidance on Hand Sanitizer Manufacturing, CARES Act Provides Tax Relief