Tag Archives: FDA

FDA Publishes Goals for Supporting Antimicrobial Stewardship in Veterinary Settings for Fiscal Years 2019-2023

On July 31, 2018, FDA announced that it was working on a five-year blueprint to combat antimicrobial resistance in animals.  On September 14, 2018, FDA published Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023. FDA provides action items to promote three goals; we summarize several major steps for each; Align Antimicrobial Drug … Continue Reading

FDA Commissioner Discusses FDA’s Efforts to Prevent Foodborne Cyclospora Outbreaks

FDA Commissioner Scott Gottlieb has issued a press release in the aftermath of this summer’s Cyclospora (C. cayetanensis) outbreaks in fresh produce, highlighting the Agency’s efforts to prevent outbreaks of this foodborne illlness.  Cyclospora is an intestinal parasite that is spread through contamination of food with human waste. FDA has been surveying the food supply … Continue Reading

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data.  As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

USDA and FDA Announce Joint Meeting on Animal Cell Culture Technology

Yesterday, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. As we previously reported on this blog, FDA held a public meeting on … Continue Reading

FDA Expands ANAB Recognition under the Accredited Third-Party Certification Program

The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety … Continue Reading

FDA Announces New Export Certification Program

The U.S. Food and Drug Administration (FDA) recently announced a new export certification program, along with the fees that will be assessed, for certain FDA-regulated food products. The fees will apply to products, such as produce, grains, processed foods, food additives, color additives, food contact substances, and infant formula. “We anticipate that this new export … Continue Reading

FDA Issues Statement Regarding Labeling Coffee as a Carcinogen Consistent with California Proposition 65

California Proposition 65 requires manufacturers to provide clear and reasonable warnings to consumers before exposing them to over 950 listed carcinogens, including acrylamide.  As reported in this blog yesterday, California’s regulations for reporting the presence of the carcinogens have changed.  Also as previously reported in this blog, producers of roasted coffee have been sued under … Continue Reading

FDA Extends Deadline for Comments on Nutrition Innovation Strategy

At the National Food Policy Conference in March 2018, FDA Commissioner Scott Gottlieb, M.D., announced the creation of the Nutrition Innovation Strategy (NIS).  The NIS is intended to improve public health by educating consumers and encourage innovation to expand the use of nutrition in reducing the instances and impact of chronic disease.  FDA held a … Continue Reading

FDA Commissioner Gottlieb Issues Statement On Advancing the Science and Regulation of Live Microbiome-Based Products

FDA Commissioner Scott Gottlieb, MD, issued a statement on August 16 regarding the role of microorganisms on health.  Dr. Gottlieb provided background on the use and regulatory status of microorganisms. Also in his statement, Commissioner Gottlieb provided the underlying rationale for his statement via the example of probiotics administered to premature infants as a preventive … Continue Reading

FDA Releases Q&A for Preventive Controls for Animal Foods

In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading

FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule

On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule under the Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls … Continue Reading

Former Director of the FDA’s Office of Biotechnology Pens Op-Ed Criticizing FDA Enforcement on Organic Labeling, FDA Commissioner Pledges to Look at Labeling Claims in Organics

In a Wall Street Journal op-ed, Dr. Henry Miller, the former founding director of the FDA’s Office of Biotechnology, criticizes FDA as giving organic food labeling and advertisement “a complete pass.”  The author calls out FDA’s lack of enforcement on claims that organic foods are grown “without toxic or persistent pesticides,” noting that in fact, … Continue Reading

FDA Announces Upcoming Efforts to Combat Antimicrobial Resistance in Animals

In a July 31, 2018 press release, FDA Commissioner Scott Gottlieb announced upcoming efforts by FDA to implement “good antimicrobial stewardship practices.”  FDA’s Center for Veterinary Medicine (CVM) has already taken steps to support judicious use in animals of antimicrobials important for treating human disease. FDA will soon publish a five-year blueprint to further address … Continue Reading

FDA Issues First Warning Letter for Alleged HARPC Violations

On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be … Continue Reading

FDA Holds Public Meeting on Comprehensive, Multi-Year Nutrition Innovation Strategy

In a March 29 speech at the National Food Policy Conference, FDA Comissioner Dr. Scott Gottlieb announced the Nutrition Innovation Strategy (NIS).  Commissioner Gottlieb hopes to improve public health by: (1) empowering consumers to make better and more informed decisions about their diets, (2) encourage the development of healthier foods, and (3) expand the use … Continue Reading

Senators Urge FDA to Get Tough on Flavored Vaping Products

Fourteen senators, including Senate Minority Whip Dick Durbin (D-IL), have sent a letter to FDA criticizing the agency for what it characterizes as lax enforcement that has allowed children to get addicted to flavored vape products in recent years.  In particular, the letter calls out flavors like gummy bear, cotton candy, peanut butter cup, and … Continue Reading

FDA to Issue a Guidance Document Limiting Use of Milk in Plant-Based Beverages

In the 2018 POLITICO Pro Summit, FDA Commissioner Scott Gottlieb signaled that FDA will begin collecting comments regarding enforcement of standard of identity for “milk”.  As noted in our June 27 blog, FDA is holding a public meeting on July 26, 2018 to discuss its Nutrition Innovation Strategy, including standards of identity.  FDA indicated in … Continue Reading

California Court Rules Cereals Not Required to Bear Proposition 65 Warnings (Law360 Subscription Required)

On Monday, July 16, a California appeals court reversed a decision that would have required food manufacturers to label cereal products with cancer warnings, as per Proposition 65. As we have previously written on this blog, Proposition 65 is a right-to-know law that requires businesses to provide warnings when they knowingly cause exposures to chemicals … Continue Reading

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
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