Tag Archives: FDA

Arkansas Passes Resolution Calling for Standard for Rice

Over the last year, dairy industry groups have appealed to FDA and Congress to enforce the standard of identity for milk with regard to plant-based beverages labeled as “milk,” for example “soy milk”.  The dairy industry argues that milk is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of … Continue Reading

FDA Guidance States Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulations

On March 21, 2018, the U.S. Food and Drug Administration (FDA) published guidance that live animals processed under Department of Agriculture (USDA) regulations do not need to comply with Foreign Supplier Verification Program (FSVP) requirements. In general, live animals imported for use as food are regulated by FDA. However, they are required to be slaughtered … Continue Reading

FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered … Continue Reading

FDA Announces Proposed EU Shellfish Equivalence Determination

The United States and the European Union (EU) have not traded live shellfish for nearly eight years. Since 2010, U.S. shellfish imports have not been allowed to enter the EU, and the U.S. Food and Drug Administration (FDA) has not permitted the import of live, fresh or fresh-frozen molluscan shellfish from the EU since the … Continue Reading

GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

The Food Safety Modernization Act (FSMA), enacted in January 2011, shifted the FDA’s focus from responding to illnesses to preventing food contamination.  A new report by the U.S. Government Accountability Office, released on March 5, 2018, examines FDA’s actions on food safety since FSMA became effective. The GAO report, titled “FDA Can Build on Existing Efforts … Continue Reading

NTP Releases Draft Report on Bisphenol A for Public Comment

Bisphenol A (BPA) has been the subject of global controversy in recent years, with some jurisdictions restricting its use in children’s products and baby bottles due to concerns about potential exposure risks. FDA’s longstanding position on BPA is that BPA is safe at the current levels occurring in foods. On February 23, 2018, the National … Continue Reading

FDA Updates Spice Risk Profile

As previously reported on this blog, the U.S. Food and Drug Administration (FDA) released a draft risk profile on the public health risks associated with spices in October 2013. The risk profile identifies the presence of pathogens, such as Salmonella, and filth in spices; describes current efforts to reduce the public health risk posed by … Continue Reading

New DOJ Policy Says Government Lawyers Cannot Base Enforcement Actions on Guidance Documents

As our readership is well aware, the U.S. Food and Drug Administration (FDA) frequently issues guidance documents for all areas under its regulatory purview, including foods. These guidance documents seek to clarify and supplement existing regulations. On November 16, 2017, Attorney General Jeff Sessions ostensibly expressed a distaste for binding private parties to provisions in … Continue Reading

House Passes Bill to Ease Menu Labeling Rules

Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar … Continue Reading

FDA Recognizes First Accreditation Body Under Accredited Third-Party Certification Program

As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet … Continue Reading

FSMA Update: More Clarification on FSVP from FDA

As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document on how to comply with the foreign supplier verification program (FSVP) final rule, under the Food Safety Modernization Act (FSMA). The FSVP regulation establishes requirements relating to: the … Continue Reading

Panera Petitions FDA to Define “Egg”

The term “egg” is not specifically defined by FDA.  In fact, 21. C.F.R. 160.100 provides that “no regulation shall be promulgated” to define “the food commonly known as eggs.” The rule has been on the books for decades. That being said, FDA does expressly define dried eggs, frozen eggs, liquid eggs, egg whites, dried egg whites, … Continue Reading

FDA Issues Draft Guidance on HARPC for Animal Food

As previously reported on this blog, FDA published final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. The Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170) can be found … Continue Reading

DuPont Challenges FDA’s Proposal to Revoke Soy-Heart Health Claim

As reported on this blog in October 2017, the U.S. Food and Drug Administration (FDA) proposed a rule to revoke a regulation authorizing the use of a health claim on the relationship between soy protein and coronary heart disease (CHD) (21 CFR 101.82) on the label or in the labeling of foods. FDA estimates that … Continue Reading

Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current recall process can be too slow and puts consumers at risk.  Yesterday, FDA Commissioner Dr. Scott Gottlieb announced plans to strengthen the recall process for food, drugs, medical devices and … Continue Reading

FDA to Begin Process of Modernizing Certain Standards of Identity

On January 11, 2018, the U.S. Food and Drug Administration released its Strategic Policy Roadmap for 2018. As part of its Strategic Policy Roadmap, FDA has signaled its intent to modernize certain standards of identity to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods … Continue Reading

FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS

Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements … Continue Reading

CDC expands use of Whole Genome Sequencing in Foodborne Illness

Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts. Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the … Continue Reading

OIG Report Finds FDA Recall Process is Slow

As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with … Continue Reading

IFSAC Releases New Report on Foodborne Illness Source Attribution Estimate for 2013

Created in 2011, the Interagency Food Safety Analytics Collaboration (IFSAC) is a partnership of three federal agencies—the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS). IFSAC aims to enhance the coordination of federal food safety analytic … Continue Reading

FDA: Antibiotics Sold and Distributed for Use in Food-Producing Animals Down in 2016

For years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production … Continue Reading

FDA Discontinues Food Advisory Committee

The Food Advisory Committee was established on March 6, 1992 (57 FR 8064).  Over the years, the Committee has provided advice to the Commissioner of Food and Drugs and other appropriate officials on emerging food and cosmetic safety, food science, nutrition, and other food-related health issues. Today, the FDA announced in the Federal Register (82 … Continue Reading