Tag Archives: FDA

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

In an October 30 press release, FDA announced their new Plant and Animal Biotechnology Innovation Action Plan in an effort to foster advances in the field as new technologies to edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity, and food security. For example, new forms … Continue Reading

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce tobacco-related disease and death, with particular emphasis on protecting kids from the dangers of nicotine. In order to do so, FDA asserted the critical need to have an efficient regulatory process that puts novel products, … Continue Reading

FDA Issues Draft Guidance on Produce Safety Requirements under FSMA

FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 … Continue Reading

Ostroff Retires as FDA Deputy Commissioner for Foods and Vet Medicine; FDA to Undergo Food Safety Reorganization

As reported by multiple outlets, Stephen Ostroff, FDA’s Deputy Commissioner for Food and Veterinary Medicine, will retire January 5. Ostroff assumed the role of Deputy Commissioner in 2016, previously serving as the acting FDA Commissioner on two occasions. Walmart’s Vice President for Food Safety and Health, Frank Yiannas, is set to replace Ostroff. Yiannas will … Continue Reading

USDA Secretary Signals USDA Role Over Animal Cell Culture Technology Regulation Ahead of Joint USDA-FDA Meeting

As previously reported on this blog, 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. The meeting will focus on potential hazards, regulatory … Continue Reading

FDA Removes Clearance for 7 Synthetic Flavoring Substances

As we previously reported on this blog, a group of non-government organizations (NGOs) sued FDA in an effort to compel the Agency to act on a Food Additive Petition (FAP) concerning seven synthetic flavoring food additives. The FAP, which the NGOs submitted to FDA, requested that FDA remove the clearances for these seven synthetically derived … Continue Reading

FDA Issues Policy and Related Draft Guidance on Publicizing List of Retailers in Certain Food Recall Situations

FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.  Historically, the agency has not released … Continue Reading

ITIF Petitions FDA to Prohibit Non-GMO Claims on Food Labels

A citizen petition filed on September 24, 2018 by the Information Technology & Innovation Foundation (ITIF) asked FDA to prohibit “non-GMO” food labeling claims, including the Non-GMO Project butterfly logo and label. ITIF argues in the petition that such claims mislead and deceive consumers about foods, food ingredients, and their characteristics related to health and … Continue Reading

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
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