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Update on the Regulation of CBD-Infused Products

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

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)

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

As FDA Considers Revisions to the Regulatory Definition, a Federal Court Agrees That Consumers Are Not Misled by Coconut Milk Marketed as “Healthy”

 Danone Dodges Deceptive Ad Suit Over Coconut Milk (Subscription to Law360 required) The U.S. District Court for the Southern District of California on August 14, 2019 dismissed a proposed class action alleging the term “healthy” is deceptive when used to market coconut milk containing high levels of saturated fat.  At issue in Andrade-Heymsfield v. Danone … Continue Reading

FDA Proposes New Graphic Warnings for Cigarettes

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

EPA Refuses to Approve Glyphosate Labels with Proposition 65 Cancer Warning

In a direct rebuke of Proposition 65’s listing of glyphosate as a carcinogen, the US Environmental Protection Agency (EPA) issued a press release on August 8, 2019 announcing that it would no longer approve glyphosate labels with the Proposition 65 warning for cancer.  EPA Administrator Andrew Wheeler is quoted in the press release as stating, … Continue Reading

FDA Issues First Warning Letter to Food Importer Under FSVP

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

Hazelnut Crème Coffee False Advertising Lawsuit Revived

1st Circuit Gives Coffee Buyers 2nd Shot at False Ad Suit (subscription to Law360 required) On August 8, 2019, the U.S. Court of Appeals for the First Circuit reversed a district court’s dismissal of a lawsuit charging that the label on New England Coffee’s Hazelnut Crème coffee violates Massachusetts’ consumer protection laws because the product … Continue Reading

FDA is Asked to Approve Vitamin D3 For Use as a Nutrient Supplement in Grain-Based Nutrition Bars and at Higher Levels Than Currently Affirmed as GRAS in Breakfast Cereals

As a vitamin that is assigned a Reference Daily Intake (RDI) in 21 C.F.R. § 101.9(c)(8)(iv), vitamin D is an “essential nutrient.”  Vitamin D without a subscript represents either vitamin D2 or vitamin D3, which are the two major physiologically relevant forms of vitamin D.  Vitamin D is affirmed as generally recognized as safe (GRAS) for use … Continue Reading

FSVP Follow-up

With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation.  The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported.  … Continue Reading

Inspections Begin Under FDA’s Produce Safety Rule

As our readers may know, the FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here. The compliance dates for the Produce Safety Rule depend on the size … Continue Reading

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

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

Congress Continues Efforts to Combat Food Waste

As previously reported on this blog, food waste is a major issue in the United States. We also have reported on previous attempts by Congress to curb food waste through legislation (see here and here). The most recent effort to reduce food waste was made by Representatives Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) when … Continue Reading

USDA Testimony Sparks Debate Over Allowing Gene Editing for Food Labeled as Organic

The National Organic Program (NOP) of the U.S. Department of Agriculture (USDA) works with the National Organic Standards Board (NOSB) to develop standards involving the production, handling, and processing of ingredients that may be used in products bearing the label “USDA organic.”  Under the current requirements for organic labeling, genetic engineering is a prohibited method … Continue Reading

A Look at the Food Handler Antiseptic OTC Rulemaking

On December 7, 2018, the Food and Drug Administration (FDA) established a docket and requested data, information, and comments to “assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter (OTC) human use.”  The request … Continue Reading

Flies Are a Potential E. Coli Vector in Leafy Green Illness Outbreaks

Researchers with the U.S. Department of Agriculture’s Agricultural Marketing Service have isolated Escherichia (E.) coli O157:H7 from a variety of pest flies in leafy green fields planted up to 180 meters away from cattle feedlots.  Among most fly species captured on sticky traps at leafy green farms, 22.3-29 flies per 1,000 flies carried E. coli O157:H7. … Continue Reading

As War Over Plant-Based Food Labeling Wages On In The US, UK Sub-Committee Concludes Consumers Not Misled By Vegetarian “Burgers”

On July 25, 2019, a United Kingdom parliamentary sub-committee found that words like “burger,” “sausage,” and “steak” to describe plant-based foods are not misleading to consumers. Indeed, the House of Lords EU Energy and Environment Sub-Committee have raised concerns that a ban on the use of such descriptors for plant-based foods would actually reduce consumer … Continue Reading

FDA Exploring Additional Regulatory Pathways for CBD Products

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 Releases Fiscal Year 2020 Fee Rates and Reconfirms Policy of Not Invoicing for FSMA Food Facility Reinspection, Recall, and Importer Reinspection Fees

The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection related costs; (2) the responsible party for a domestic facility and an importer who does not comply … Continue Reading

Tofurkey and Others Challenge Arkansas Plant-Based and Insect-Based Meat Labeling Law

The American Civil Liberties Union (ACLU), the Good Food Institute, the Animal Legal Defense Fund, and the ACLU of Arkansas recently filed a complaint on behalf of Turtle Island Foods (Tofurkey brand), challenging an Arkansas law that prohibits the representation of plant-based and insect-based products as “meat” or related terms (e.g., “beef,” “roast,” and “sausage”). … Continue Reading

FDA Suspends Topway/Kazy’s Gourmet Facility Registration

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

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

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
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