Tag Archives: FDA

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

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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

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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

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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

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  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

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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

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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

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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)

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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)

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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)

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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

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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

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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

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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

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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

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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

Trade Group Petitions FDA to Allow CBD Supplements

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In the wake of rapidly increasing sales, FDA has continued to maintain that dietary supplements containing hemp-derived cannabidiol (CBD) are illegal under the Federal Food, Drug & Cosmetic Act. FDA officials have previously stated that the agency is exploring additional regulatory pathways available to hemp products containing CBD, but predicted that completing a potential rulemaking … Continue Reading

New Proposed Class Action Over “Organic Dehydrated Cane Juice Solids”

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 Whole Foods Accused of Hiding Sugar In Oatmeal Ingredients (subscription to Law360 required) As previously covered on this blog, a claim against Whole Foods involving the term “evaporated cane juice” (ECJ) was dismissed from the “Food Court” (i.e., the Northern District of California) in 2015 because inconsistencies in the plaintiff’s statements and actions make it … Continue Reading

FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements

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  We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw materials and other ingredients under the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the … Continue Reading

American Academy of Pediatrics Raises Concerns Re Nonnutritive Sweeteners, Calls for Research and Labeling

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On October 28, 2019, the American Academy of Pediatrics (AAP) published a policy statement, in which it questions the effects of nonnutritive sweeteners (NNSs) on children’s health.  AAP notes that the Food and Drug Administration (FDA) currently requires manufacturers to list NNSs in a product’s ingredient statement but recommends also requiring producers to specify the … Continue Reading

FDA Makes Available Testing Method for PFAS in Foods and Final Testing Results

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PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications. FDA has … Continue Reading

USDA, EPA, and FDA Aim to Reduce Food Waste Through New Partnership with the Food Waste Reduction Alliance

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As previously covered on this blog, food waste is a major issue in the United States. Government estimates indicate that Americans waste between 30 and 40 percent of the overall food supply on an annual basis. According to the United States Department of Agriculture (USDA), consumers are responsible for nearly 90 billion pounds of food waste … Continue Reading

Federal Court’s Refusal to Issue Injunction is Appealed as Plaintiffs Continue First Amendment Challenge Against Missouri’s Meat Labeling Laws

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  Missouri was the first among many states, including Arkansas, Louisiana, Mississippi, North Dakota, Oklahoma, South Carolina, South Dakota, and Wyoming, to enact laws restricting plant-based and cell-cultured products from being labeled as “meat.”  As reported here, Turtle Island Foods (Tofurkey brand), in conjunction with non-profit advocacy groups, filed a lawsuit on August 28, 2018, which … Continue Reading
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