Tag Archives: FDA

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

Trade Group Petitions FDA to Allow CBD Supplements

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”

 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

  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

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

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

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

  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

FDA Extends Compliance Deadline for New Nutritional Labeling Rules

As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food … Continue Reading

FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD

On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions. As described in the … Continue Reading

Lawmaker Calls for FDA to Respond to Report on Toxic Metals in Baby Food

Toxic metals – such as arsenic, lead, cadmium, mercury and others – occur naturally and as environmental pollutants in air, water and soil and they enter the food supply when plants take them up as they grow. The Food and Drug Administration (FDA) actively monitors the levels of these metals in food and established a … Continue Reading

Trade Associations Send Letter to All Members of Congress Urging Action on CBD in Dietary Supplements

On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make … Continue Reading

FDA Publishes List of Records Required Under FSVP

As our readers may know, the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP … Continue Reading

CDC Finds Decrease in Foodborne Disease Outbreaks from 2015 to 2017

The Centers for Disease Control (CDC) has released its Surveillance for Food-borne Disease Outbreaks Annual Report, which includes an analysis of all foodborne illness outbreaks reported in 2017.   CDC found that 841 foodborne disease outbreaks were reported in 2017, resulting in 14,481 illnesses, 827 hospitalizations, 20 deaths, and 14 food product recalls.  These recent statistics show that … Continue Reading

Public Comments Urge FDA to Allow “Potassium Salt” as Alternative Name for “Potassium Chloride” in Food Labeling

Food manufacturers, including Nestle USA and Kraft Heinz, have submitted public comments on FDA’s draft guidance regarding the use of “potassium chloride salt” as an alternative common or usual name for potassium chloride. The comments opposed the use of “potassium chloride salt” and urged the agency to choose “potassium salt,” asserting that the term meets … Continue Reading

FDA Launches Dashboard to Track FSMA Progress

On September 30, 2019, FDA announced the establishment of the Food Safety Dashboard, which is designed to measure the progress of the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter … Continue Reading

FSIS Constituent Update on Availability of Food Defense Resources and Upcoming FDA Webinar on the Updated Food Defense Plan Builder

The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) work jointly and with other federal agencies, as well as state, local, and tribal government agencies to develop and implement food defense strategies.  Food defense is the protection of food products from intentional contamination or adulteration intended to harm the public … Continue Reading

FDA Partners With Leafy Greens Stakeholders in Arizona to Enhance Food Safety

The FDA has partnered with the University of Arizona, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry, with support from the Arizona Department of Agriculture, to better understand the ecology of human pathogens in the Yuma agricultural region.  The Yuma agricultural region encompasses Yuma County in Arizona … Continue Reading

Congress Continues to Seek Regulatory Clarity on CBD from FDA

A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s … Continue Reading

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

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

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

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
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