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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

USDA Announces Renewal of Substance Exemptions in the National Organic Program

As previously discussed on this blog, there is a National List of Allowed and Prohibited Substances (the “National List”) for synthetic and nonsynthetic nonagricultural (nonorganic) substances that may be used in organic handling, and nonsynthetic substances prohibited from use in organic farming under the National Organic Program (NOP) administered by the United Stated Department of … Continue Reading

Mexico’s Lower House Passes Front-of-Pack Labeling Bill

On October 11, Mexico’s lower legislative house passed a bill that would require manufacturers to place front-of-pack (FOP) warning labels on food high in sugar, sodium, or saturated fat.  The bill was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) and consists of a draft amendment to the General Labelling Specifications for … Continue Reading

Pork Workers Union Sues USDA Over New Swine Slaughter Inspection System

The United Food and Commercial Workers (UFCW) International Union, together with Public Citizen Litigation Group, filed a federal lawsuit to stop the USDA’s new swine slaughter modernization rule that eliminates line speed limits in pork slaughter plants, and ultimately gives inspection responsibility to the slaughter plants instead of USDA inspectors.  As we have previously covered … Continue Reading

Suit Over ‘No Preservatives’ Capri Sun Label Tossed

Kraft Dodges Suit Over ‘No Preservatives’ Capri Sun Label (subscription to Law360 required) A proposed class action, filed in the Northern District of Illinois on October 25, 2018, against Kraft Heinz Food Co. accused the company of falsely advertising its Capri Sun juice as containing “no preservatives” when in fact it contains citric acid. Tarzian … 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

California Chamber of Commerce Challenges Proposition 65 Warnings for Acrylamide

On October 7, 2019, the California Chamber of Commerce (“CalChamber”) filed suit in federal court against the California Attorney General, Xavier Becerra, to block the state from enforcing Proposition 65 warning requirements on foods containing acrylamide.  Acrylamide is a naturally occurring compound that develops when starches and sugars are cooked at high temperatures.  According to … Continue Reading

California’s Proposition 12 Challenged on Constitutional Grounds

As our readers may know, in November 2018, California voters passed a ballot initiative known as Proposition 12, which establishes new standards for confinement of certain farm animals and bans the sale of products that do not comply with the new confinement standards. Specifically, Proposition 12 requires that all eggs sold in the state come … 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

FDA Releases Chapter 14: Recall Plans in the Latest Installment to the Agency’s Multi-Chapter Draft Guidance on the Human HARPC Rule

  As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive Controls for Human Food.  These rules, found in 21 Code of Federal Regulations (CFR) part 117, implement the hazard analysis and risk-based preventive control (HARPC) provisions … Continue Reading

USDA Set to Unveil New Rule Combating Fraudulently Labeled “Organic” Products (Subscription to IEG Policy Required)

On September 13, deputy administrator of USDA’s National Organics Program (NOP), Jennifer Tucker, announced at the Natural Products Expo East in Baltimore, Maryland that the agency will soon release its new organic enforcement rule with the goal of protecting consumers from food products fraudulently labeled as “organic.” The new rule, which Tucker asserted would have … 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

USDA Seeks Public Input Ahead of 41st Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)

The U.S. Department of Agriculture (USDA) announced on September 24 that it will hold a public meeting to provide interested parties an opportunity to address items on the agenda of the 41st Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). Meeting participants will be given the opportunity to comment … Continue Reading

USDA Releases Additional FAQs on Bioengineered Food Disclosure Standard

USDA’s Agricultural Marketing Service (AMS), which promulgated the National Bioengineered (BE) Food Disclosure Standard, has announced additional responses to its Frequently Asked Questions (FAQs).   A total of five new FAQs have been published, one of which confirms that BE labeling information need not be provided online or in catalogs (i.e., disclosure on the label itself is … 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

FDA Announces Cooperative Agreement to Implement Produce Safety Rule

As previously reported, both states’ departments of agriculture and FDA have begun visits to produce farms to conduct inspections for compliance with the Produce Safety Rule. 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 … Continue Reading

USDA Publishes Final Rule to “Modernize” Pork Inspection

As we have previously covered on this blog, on February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). The proposal had received pushback from consumer groups and several media outlets, with FSIS defending its proposal … 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
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