Tag Archives: FDA

Mitch McConnell Introduces Bill Amendment That Would Compel FDA to Issue CBD Enforcement Discretion Policy

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Senate Majority Leader Mitch McConnell (R-KY) has introduced language into a Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).  The amendment, which was shared with the U.S. Hemp Roundtable, would require FDA to provide Congress with a report on how it will develop its … Continue Reading

FDA Issues Draft Guidance on Reconditioning Fish

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The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry, titled, “Reconditioning of Fish and Fishery Products by Segregation.” This draft guidance explains two potential approaches to separating non-violative portions of fish and fishery products from portions that are adulterated due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The two … Continue Reading

FDA Will Seek to Remove Flavored E-Cigarettes from the Market

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On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy to prioritize enforcement of the premarket authorization requirements against non-tobacco flavored e-cigarettes. E-cigarettes on the market as of August 8, 2016, the effective date of FDA’s … Continue Reading

Coconut Industry Campaigns to Remove Coconuts from “Top 8” Allergen List

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On September 10, the Coconut Coalition of the Americas (CCA) launched a campaign to remove coconuts from the “top 8 allergen” list.  As our readers likely know, the Food Allergen Labeling Consumer Protection Act (FALCPA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require the labeling of foods that contain the eight most … Continue Reading

FDA Announces Modernization of NDIN Electronic Submission System

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FDA has announced that it is launching a new electronic submission system for New Dietary Ingredient Notifications (NDINs) on Friday, September 6.  The new system, the CFSAN Online Submission Module (COSM) is replacing the current FDA Unified Registration Listing System (FURLS).   NDINs are required to be submitted to FDA at least 75 days before marketing … Continue Reading

Amidst Regulatory Uncertainty, Cell-Based Meat Startups Form Coalition

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As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) have announced an agreement to share regulatory oversight over cell-based or cell-cultured meat. As part of the agreement, FDA will conduct premarket consultation to evaluate the manufacture of these products, including oversight of tissue collection, … Continue Reading

FDA Announces Public Meeting to Discuss Modernizing Food Standards of Identity

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FDA will hold a public meeting on September 27, 2019 to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity (SOI) and to provide information about changes the FDA could make to existing standards of identity.  Modernizing standards of identity is part of the agency’s Nutrition Innovation Strategy, with the … Continue Reading

Update on the Regulation of CBD-Infused Products

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As previously reported on this blog, state regulators want a role in the regulation of CBD-infused food, beverages, and supplements. And while industry has been pressuring FDA to create a pathway for the lawful use of CBD in food and dietary supplements, currently, under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD (or … Continue Reading

FDA Issues Guidance on Conversion Factors for Various Nutrients

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FDA has issued Guidance for Industry (“Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels”) on how to declare certain vitamins and minerals whose recommended daily intakes (RDIs) changed when FDA issued its revisions to 21 CFR 101.9 in 2016. While some changes to … Continue Reading

FDA Sued for Failure to Establish FSMA Accredited Labs Program by Statutory Deadline (subscription to Law360 required)

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On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the FDA in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the … Continue Reading

FDA Proposes New Graphic Warnings for Cigarettes

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The Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by Section 201 of the Family Smoking Prevention and Tobacco Control Act (TCA; signed into law on June 22, 2009) directs the U.S. Food and Drug Administration (FDA) to develop graphic warnings for cigarette packages and promulgate regulations requiring the warnings within 24 months of … Continue Reading

FDA Issues First Warning Letter to Food Importer Under FSVP

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On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP).  As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance … Continue Reading

New Study Finds Prevalence of Sesame Allergy, as Illinois Becomes First State to Mandate Sesame Labeling on Packaged Foods

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A new study by researchers from Northwestern University found that 0.49% of Americans, or 1.5 million children and adults, reported having an allergy to sesame, based on responses to a national survey of over 50,000 households. The results of the study indicate that there may be more Americans with a sesame allergy than there are … Continue Reading

FDA Exploring Additional Regulatory Pathways for CBD Products

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In testimony before the U.S. Senate Committee on Agriculture, Nutrition, and Forestry on July 25, FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., reiterated that FDA “is committed to advancing hemp products through the Agency’s existing regulatory pathways.” She added that the Agency is “further exploring whether it would be appropriate to make additional regulatory … Continue Reading

FDA Suspends Topway/Kazy’s Gourmet Facility Registration

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On July 22, 2019 the Food and Drug Administration (FDA) announced that it had suspended the food facility registration of Topway Enterprises, Inc, doing business as Kazy’s Gourmet of Houston, Texas. The suspension follows inspections conducted by the FDA and the Texas Department of State Health Services earlier this year, where sanitation issues were noted, … Continue Reading

FDA Announces FSMA Third-Party Certification Program User Fee Rates for Fiscal Year 2020

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On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized by the Third-Party Certification Program, as authorized by the 2011 Food Safety Modernization Act (FSMA). Under … Continue Reading

State AGs Want Role in Regulation of CBD-Containing Products

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Many, including state regulators, are closely watching the U.S. Food and Drug Administration (FDA) as it works through the challenges associated with regulating cannabidiol (CBD) products.  Under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD cannot lawfully be added to a food or marketed as a dietary supplement; however, industry has been pressuring … Continue Reading

FDA Publishes Final Rule on Tolerances for Animal Drugs in Food

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On July 10 FDA finalized its rule on Updating Tolerances for Residues of New Animal Drugs in Food.  This rule was originally proposed in 2012 with a revision proposed in 2016.  The rule will become effective September 9. As described in the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Update, the new … Continue Reading

FDA Holds Ground in Challenge over GE Animal Regulatory Authority

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As previously reported on this blog, on June 11, the President issued Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products, ensuring coordination across federal regulatory agencies for biotechnology products. Referring to gene-edited crops and animals, the executive order told regulators to use their existing powers “to exempt low-risk products of agriculture biotechnology from … Continue Reading

Updated FDA Advice on Fish Consumption for Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children

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On July 9, 2019 the Food and Drug Association (FDA) announced the availability of “Advice about Eating Fish: For Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children.”   The update follows a 2019 congressional directive mandating that the original 2017 version, “Advice about Eating Fish,” be updated in a manner consistent with … Continue Reading

Upcoming Public Workshop to Provide Update on FDA’s Predictive Toxicology Roadmap

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Adequate toxicological data – often involving the sacrifice of laboratory animals – are necessary for reaching a safety decision on the products that are subject to FDA’s regulatory review.  FDA’s Predictive Toxicology Roadmap, published in December 2017, is a six-part framework for integrating predictive toxicology methods into the Agency’s safety and risk assessments.  FDA’s initial … Continue Reading

Bill Introduced to Protect State Cannabis Programs from Federal Interference

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As previously reported on this blog, while the 2018 Farm Bill removed hemp from the Controlled Substances Act, its passage did not affect FDA’s authority to regulate cannabidiol (CBD) or other hemp products in FDA-regulated products. In December 2018, FDA released a statement clarifying that it is illegal to sell a food or dietary supplement that … Continue Reading
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