Tag Archives: FDA

FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices

FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices   On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.”  … Continue Reading

FDA Sampling Survey Interim Data: Frozen Berries

The U.S. Food and Drug Administration (FDA) and industry are continually seeking innovative ways to curb foodborne illness outbreaks. As covered previously on this blog, FDA has undertaken a robust surveillance sampling program intended to promote food safety. In 2014, the Agency launched a proactive sampling program for a variety of commodities to learn more … Continue Reading

In the Wake of Heightened Regulatory Scrutiny of Vaping Products, Nicotine-Containing Toothpicks are Next to Come Under Fire by FDA

The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and … Continue Reading

FDA Publishes Statement on the Salinas-Linked Romaine Lettuce E. Coli 0157:H7 Outbreak and Status Update on Investigations

On December 12, 2019, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state and local partners, reported an update of its investigation tracking three separate outbreaks linked to romaine lettuce caused by three different strains of E. coli O157:H7.  FDA reported that, through its traceback investigation … Continue Reading

Bipartisan Group of Representatives Introduces Bill that Would Give FDA Authority to Regulate CBD as a Dietary Supplement (Law360 subscription required)

On January 13, 2020, the House Agriculture Committee Chairman Collin Peterson (D- Minn.) introduced H.R. 5587, which would include hemp derived CBD in the definition of dietary supplements under the Federal, Drug and Cosmetic Act.  The bill would also require a study and report from the U.S. Department of Agriculture, which oversees the production of … Continue Reading

FDA Responds to Three Dietary Fiber Citizen Petitions

On January 10, the FDA announced that it intends to propose that “glucomannan” be added to the definition of dietary fiber at 21 CFR 101.9(c)(6)(i). Based on available evidence, FDA determined that the scientific evidence suggests that glucomannan can help reduce blood cholesterol.  Glucomannan is commonly found in the tuber or root of the elephant … Continue Reading

FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices and Companies and Products that FDA Views as Targeting Kids

On January 8, 2020 FDA published its new final compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Under the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of … Continue Reading

Release by FDA, USDA, and EPA of New Joint Website on Biotechnology Regulation

  The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020.  According to the FDA News Release, this new website is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural … Continue Reading

CSPI Asks FDA Not To Make Sweeping Changes to Food Standards of Identity

As our readers may recall, FDA held a public meeting on September 27, 2019, to discuss FDA’s efforts to modernize food Standards of Identity (SOI) and to provide information about changes the FDA could make to existing SOIs. Section 401 of the Federal Food, Drug, & Cosmetic Act gives FDA authority, whenever in its judgment … Continue Reading

FDA Issues Final Guidance Document on Nutrition Facts Label and Serving Size Rules

In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and updating regulations on serving sizes to – among other things – provide realistic Reference Amounts Customarily Consumed (RACCs).  Detailed summaries of both rules may be found here.  For manufacturers with $10 million or more in annual food sales, the compliance … Continue Reading

Senate Confirms Dr. Stephen Hahn as New FDA Commissioner

On December 12, the U.S. Senate confirmed Dr. Stephen Hahn to be the next FDA Commissioner. Dr. Hahn will take over for Admiral Brett Giroir, Assistant Secretary for Health within the Department of Health and Human Services, who has been overseeing the FDA since Ned Sharpless’s tenure as “acting” FDA Commissioner expired in November 2019. … Continue Reading

Putative Class Action Alleges Company’s CBD Products for Humans and Animals Violate Federal Law (subscription to Law360 required)

As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling a variety of FDA-regulated products (for humans and animals) containing cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA emphasized that CBD lacks an appropriate regulatory status for use in these … Continue Reading

U.S. Court of Appeals for the Seventh Circuit Finds that Plaintiffs Did Not Suffer a Concrete Harm When They Purchased Allegedly Underfilled Boxes of Chocolate (subscription to Law360 required)

On December 9, 2019, the Seventh Circuit found that an Illinois federal district court properly tossed a proposed slack-fill class action against Fannie May, a Chicago-based chocolate maker.    In 2018, Plaintiffs claimed that they relied on the size of the packaging to gauge the amount of product inside and would have paid less for the … Continue Reading

Proposed Class Action Alleges Company’s CBD Products Violate Federal Law (subscription to Law360 required)

As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling FDA-regulated products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA alleged that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, … Continue Reading

Senator Gillibrand Announces Bill to Expand FDA’s Investigative Authorities

As our readers know, this blog has previously covered the romaine lettuce E. coli outbreaks that occurred in the spring and fall of 2018. Ultimately, FDA determined that the outbreak that occurred in the spring of 2018 may have been caused by Concentrated Animal Feeding Operations (CAFOs) in the Yuma, Arizona area, and the outbreak that … Continue Reading

CBD Update: FDA Takes More Aggressive Enforcement Action in Warning Letters to Companies

On November 25, 2019, FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products cited in the warning letters cover a wide range of forms including oils, drops, dietary supplements, conventional food (including gummies, peanut butter, … Continue Reading

FDA Works to Find Source of Multi-State Outbreak of E. coli Infections

On November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating an outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 infections that has so far impacted at least 17 people across 8 states. The first reported … Continue Reading

Former FDA Commissioner Scott Gottlieb Calls for a Ban on Vaping Products Most Widely Used by Youth

On November 19, 2019, former FDA Commissioner Scott Gottlieb opined on how the FDA should proceed in regulating e-cigs to address the “youth epidemic” but also preserve the devices’ potential to help adult smokers quit cigarettes.  Gottlieb argues that “providing adult smokers with a safer alternative to cigarettes cannot come at the expense of addicting … Continue Reading

FDA Issues 2019 Voluntary Retail Food Regulatory Program Standards

FDA issued the 2019 edition of the Voluntary National Retail Food Regulatory Program Standards (“Retail Program Standards”) on November 14.  The Retail Program Standards define the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory jurisdictions. The Retail Program Standards also provide recommendations for designing and managing … Continue Reading
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