Category Archives U.S. Government and Regulatory Agencies

The U.S. Department of Justice (DOJ) has announced that Michael Casey, vice president of Casey's Seafood Inc., has pleaded guilty to charges of falsely labeling almost 400,000 pounds of crab meat as derived from Atlantic blue crab in the United States despite importing the meat from a number of countries, including Indonesia, China, Thailand and Vietnam. Casey's guilty plea comes after a conviction for his father on similar charges. The foreign crab meat, which the company reportedly repacked into containers labeled "Product of USA," had a wholesale value of approximately $4,324,916. “U.S. consumers expect the origin of their seafood to be correctly identified. When sellers attempt to deceive the public about their product’s origins, they put the public’s health at risk by introducing seafood of unknown origin,” a DOJ investigator is quoted as saying in an agency press release. “When sellers are deceptive about their products’ origins, they deprive the…

A group of 38 state attorneys general have submitted a letter to the U.S. Food and Drug Administration (FDA) in response to the agency's call for comments on possible regulatory approaches for cannabis and cannabis-derived products such as cannabidiol (CBD). "As the primary enforcers of our respective states' consumer protection laws, we offer a unique perspective as to the new legalized market of certain cannabis and cannabis-derived compounds, including CBD products," the letter states. "A crucial element of FDA regulation and oversight should be an on-going assessment of the potential risks or benefits of these products, particularly for specific populations such as pregnant women, adolescents and children, and the elderly. How these products interact with other dietary or pharmaceutical products should be included in this assessment. It is also important that companies not mislead consumers. Scientific and medical data from the FDA would assist in meaningful enforcement of advertising laws…

The Environmental Protection Agency (EPA) has reportedly rejected efforts to ban chlorpyrifos, finding that "the data available are not sufficiently valid, complete or reliable to meet petitioners' burden to present evidence demonstrating that the tolerances are not safe." The decision follows a 2015 ban and 2017 reversal, which prompted legal challenges. EPA will reportedly continue to review the safety of chlorpyrifos through 2022.

The U.S. Food and Drug Administration (FDA) has issued guidance revising advice for pregnant women about safe fish consumption. “Advice About Eating Fish: For Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children” includes "a statement that eating fish when pregnant or breastfeeding can provide health benefits and states that fish and other protein-rich foods have nutrients that can help children's growth and development. The revisions also include a statement that, as part of a healthy eating pattern, eating fish may offer heart health benefits and lower the risk of obesity. The revised advice also makes clear that many types of fish are both nutritious and lower in mercury." FDA will accept comments until September 9, 2019, about suggested additional target populations for the advice, suggestions for effective means to distribute the advice and other information that may be useful to include.

The U.S. Department of Agriculture (USDA) has released guidance on meal kits requiring inspection by the agency's Food Safety and Inspection Service (FSIS). The guidance indicates that meal kits do not require assembly subject to FSIS inspection if (i) the "meat or poultry component is prepared and separately packaged under FSIS inspection and labeled with all required features"; (ii) the "outer kit label identifies all of the individual components in the kit"; and (iii) the "outer kit label clearly identifies the product as a single unit or 'kit,' such as 'Chicken BBQ Dinner Kit' and 'Beef Lasagna Meal.'"

The U.S. Food and Drug Administration (FDA) has issued an update for consumers explaining its investigations into cannabis and cannabis-derived compounds, including cannabidiol (CBD). The agency indicates that it is "working to learn more about the safety of CBD and CBD products," specifically: (i) "[t]he effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time"; (ii) "[t]he cumulative exposure to CBD if people access it across a broad range of consumer products"; (iii) "[t]he effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed, or class)"; and (iv) "[t]he safety of CBD use in animals (e.g., species, breed, or class) including pets." FDA also advises that "unapproved CBD drug products have not been subject to FDA review as part of the drug approval process,…

The U.S. Food and Drug Administration (FDA) has announced that it will not object to claims that "consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease." FDA's research on the claim included reviewing more than 700 studies and 22 public comments submitted on the subject. The approved qualified health claims include that EPA and DHA "may help lower blood pressure" and "reduce the risk for hypertension" but also reference that "FDA has concluded that the evidence is inconsistent and inconclusive."

U.S. Sen. Dick Durbin (D-Ill.) and Rep. Rosa DeLauro (D-Conn.) have introduced the Safe Food Act of 2019, "which would create a single, independent food safety agency." In addition, the proposed law would "[r]equire full food traceability to better identify sources of outbreaks" and "[s]trengthen oversight of foreign food facilities and improve food import inspections." The proposal echoes similar legislation the pair proposed in 1999.

The National Advertising Division (NAD) has recommended that Oatly Inc. discontinue marketing representations that its oat milks contain "no added sugars." According to NAD's summary, the challenger argued that "the hydrolysis process, which turns oats into oatmilk, creates sugars 'in situ' as the oats are broken down into smaller components." NAD considered whether the question fell under its jurisdiction, noting that information appearing in the Nutrition Facts Panel would be governed by the U.S. Food and Drug Administration (FDA). "Without taking a position on whether Oatly’s Nutrition Facts Panels are in compliance with FDA regulations, NAD recommended that Oatly not re-post or restate the 'added sugars' line of the Nutrition Facts Panel in its advertising, but noted that nothing in the decision prevents Oatly from using the 'added sugars' line of the Nutrition Facts Panel in a context that is not advertising, such as on product packaging for the purpose…

Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an amendment to the House Agriculture appropriations bill that would give the U.S. Food and Drug Administration (FDA) funding to undertake the process to identify a safe daily intake level of cannabidiol (CBD). “Since the passage of the 2018 Farm Act – which eliminated hemp from the definition of marijuana under the Controlled Substances Act – we’ve seen a significant increase in the production and sales of CBD products,” said McNerney in a June 18, 2019, press release. “With more and more CBD appearing on supermarket shelves across the country, it’s time for American consumers to have accurate information on CBD and for producers to be properly regulated to make the marketplace safe and reliable.” FDA has also announced the extension of the comment period for the public hearing intended to "obtain scientific data and information…

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