Tag Archives: FDA

Expanded FDA Electronic System Now Includes All Exports Lists

The U.S. Food and Drug Authority (FDA) announced the launch of an electronic portal, Export Listing Module (ELM), for receiving and processing requests from FDA- regulated establishments that want to be included on export lists for FDA-regulated food products. By way of background, some foreign authorities require FDA to provide publicly available lists of exporters … Continue Reading

FDA Survey of the Cosmetics Industry on Current Manufacturing Practices

The U.S. Food and Drug Administration (FDA) announced yesterday, July 2, 2018, an opportunity for public comment on a proposed survey of the manufacturing practices and standards employed across the cosmetic industry to ensure product quality and safety. The survey is intended to provide the industry with a systematic and detailed study of the current … Continue Reading

Trump Administration Proposes to Consolidate Food Safety Authority into One Agency

In a June 21, 2017 document titled “Delivering Government Solutions in the 21st Century:  Reform Plan and Reorganization Recommendations,” the Trump Administration proposes to replace the U.S. Food and Drug Administration (FDA) and Food Safety and Inspection Service (FSIS) with a single agency called the Federal Food Safety Agency.  If the recommendations were to be … Continue Reading

FDA Announces Public Meeting to Discuss Nutrition Innovation Strategy

In March, FDA Commissioner Dr. Scott Gottlieb announced a comprehensive, multi-year FDA Nutrition Innovation Strategy, which aims to modernize FDA’s approach to nutrition, help reduce the burden of chronic disease that stems from poor nutrition, and remove barriers to industry innovation. On June 27, 2018, FDA published a notice of public meeting and a request … Continue Reading

FDA Issues First Draft Guidance Document on Intentional Adulteration

As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food Safety Modernization Act (FSMA).  These rules are intended to guard against the deliberate adulteration of food by employees. The 94-page guidance provides an overview of … Continue Reading

FDA to Revise Approach to Labeling Some Added Sugars

As previously reported on this blog, FDA published a draft guidance in February 2018 to help industry declare added sugars on the label of pure honey, pure maple syrup, and certain cranberry products. More than 3,000 comments were submitted on the draft guidance by the June 15, 2018 deadline. The comments on the draft guidance can … Continue Reading

FDA Releases Guidance on Dietary Fiber

Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels”.  This direct-to-final guidance provides additional clarity on which isolated and synthetic non-digestible carbohydrates (NDCs) will be recognized by … Continue Reading

FDA Releases Guidance on Evaluating Animal Drug Safety in Food-Producing Animals

FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3:  General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals) describing the types of information that the Center expect to see when such drugs are used in food-producing animals. Under Section 512(b)(1) of … Continue Reading

Bipartisan Bill Would Protect State Marijuana Laws

Several U.S. Senators introduced a bipartisan bill titled, Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), on June 7. The bill would allow states, U.S. territories, and federally recognized tribes to choose how to regulate the use of marijuana within the borders of their state without federal interference. However, the bill would leave certain … Continue Reading

FDA and CDC Release Results of 2017 National Youth Tobacco Survey

On June 7, FDA and CDC released the results of the 2017 National Youth Tobacco Survey.  Total number of high- and middle-school tobacco users of any tobacco product continued to fall to unprecedented levels, dropping over 20% between 2011 and 2017, from approximately 4.56 million to 3.62 million youth users.  Comparing tobacco use as a percentage … Continue Reading

FDA and USDA Announce Collaborative Effort to Align Produce Safety Requirements

On June 5, 2018, FDA and USDA announced a new collaborative effort to streamline produce safety requirements for farmers by aligning the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule. This effort follows the signing of a formal agreement in … Continue Reading

Continuing Fallout from E. Coli Outbreak in Romaine

According to the Wall Street Journal (paywall), the impact of the recent E. coli outbreak in romaine lettuce continues to ripple through the market, causing a 44.5% drop in retail sales of romaine as compared to the previous year and a 27.6% drop in sales of lettuce overall. Retailers, restaurants, and growers are already facing … Continue Reading

FDA Issues Food Facility Registration Small Entity Compliance Guide

FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to … Continue Reading

FDA Encourages Importer Preparation for Next VQIP Application Cycle

As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program … Continue Reading

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, … Continue Reading

Non-Profits Sue FDA to Prohibit Use of Seven Flavors

Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit … Continue Reading

WHO Offers Plan to Eliminate Industrially-Produced Trans Fatty Acids

One week after suggesting that adults and children reduce their intake of trans fatty acids to less than 1% of total energy intake (see our May 8, 2018 blog for details), the World Health Organization (WHO) released a plan aimed at eliminating industrially-produced trans fatty acids from the global food supply. The plan, REPLACE, is … Continue Reading

FDA Releases Intentional Adulteration Training Course

In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration. The training … Continue Reading

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules; USDA Proposes National Bioengineered (BE) Food Disclosure Rules

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules In the Federal Register for May 4, 2018, FDA issued a final rule that confirms the extension of the compliance dates for two labeling rules from July 26, 2018 to January 1, 2020 for manufacturers with $10 million or more in annual … Continue Reading

FDA and FTC Take Enforcement Action on E-Liquids That Resemble Foods

FDA has joined the Federal Trade Commission (FTC) in issuing warning letters to 13 companies that market nicotine-containing e-liquids in packaging that has the appearance of being foods that appeal to children, such as juice boxes, candies, and cookies. FDA and FTC took action based on the risk that consumers, especially children, may confuse the … Continue Reading

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