Five public advocacy groups have filed suit against the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) seeking to vacate FDA’s “Substances Generally Recognized as Safe” (GRAS) rule, which allegedly allows “potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug and Cosmetic Act (FDCA).” Ctr. for Food Safety v. Price, No. 173833 (S.D.N.Y., filed May 22, 2017). The plaintiffs argue that the GRAS rule allows manufacturers to certify that a substance is GRAS without notice to FDA or the public, although the rule gives them the option to notify the agency about certification. However, they allege, the Food Additives Amendment to the FDCA requires food additives to go through an FDA approval process. FDA allowed manufacturers to begin using the proposed rule’s optional notification…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued a May 28, 2013, ruling that will allow alcoholic beverage manufacturers “to provide consumers with nutritional information about their products.” Acting under the authority of the Federal Alcohol Administration Act, TTB will permit the use of “Serving Facts” statements on wine, distilled spirits and malt beverages that describe the product’s “serving size, the number of servings per container, the number of calories, and the number of grams of carbohydrates, protein, and fat per serving.” Manufacturers may also choose to include information “about the alcohol content of the product as a percentage of alcohol by volume and may also include a statement of the fluid ounces of pure ethyl alcohol per serving.” According to the new ruling, TTB issued the voluntary guidance pending plans to require similar Serving Facts statements on all alcoholic beverage labels.…
The U.S. Department of Agriculture has announced that the Animal and Plant Health Inspection Service (APHIS) will host public meetings to hear comments on proposed revisions to regulations governing importation, interstate movement and environmental release of certain genetically modified organisms (GMOs). Public meetings will be held in Kansas City, Missouri; Davis, California; Riverdale, Maryland; and via webcast in June 2017. Written comments may also be submitted. Issue 635
A Washington Post report tracking multiple shipments of corn and soybeans imported from Turkey has purportedly found that the food was sold in the U.S. market fraudulently labeled as organic. The article argues that U.S. Department of Agriculture organic standards create loopholes that allow fraud to slip through. Organic corn and soybeans grown outside of the United States are required to be inspected, the Post asserts, but they are not required to be tested for pesticide residue, and inspectors that do test have apparently found high levels of pesticide use on the supposedly organic foods. The Post tracked three shipments: the first was rejected by the importing company for failing to have proper documentation, the second was fraudulently relabeled as organic soybeans before being accepted by its importing company, which has since stopped selling "all potentially affected product," and the third was rejected by importers but continued to be marketed…
A group of California citrus growers has sued the U.S. Department of Agriculture seeking to stop implementation of a new rule that would lift the ban on importation of lemons from Argentina, claiming the rule violates both “sound science and good public policy.” U.S. Citrus Sci. Council v. USDA, No. 17-0680 (E.D. Cal., filed May 17, 2017). The plaintiffs assert that the United States has banned Argentine lemon imports since 1947 because “highly destructive plant pests and diseases plague Argentine citrus” and the Argentine government agency charged with plant protection “has a long and problematic history of failing to report pest and disease outbreaks promptly and of failing to ensure compliance” with basic plant protection measures. The plaintiffs argue that the Animal and Plant Health Inspection Service violated both the Plant Protection Act and the Administrative Procedure Act when it promulgated the new rule relying on conclusions reached during a…
Even if Kauai Coffee pods are “certified 100% compostable,” as its ads claim, the National Advertising Division (NAD) says the company does not make clear to consumers that the pods can only be composted in industrial facilities rather than backyard compost piles. NAD has recommended that Kauai discontinue existing print and website advertising or modify it to “clearly and conspicuously disclose” that the single-serve pods are only compostable in certain facilities. The ad board confirmed that the pods have been certified by the Biodegradable Products Institute, the official agency for recognition of compostable products, but noted that the lack of disclosure may be a violation of the Federal Trade Commission’s Green Guides. Issue 635
Syfrett Feed Co., a Florida manufacturer of medicated animal feeds, has entered into a consent decree to control its production process and comply with federal laws before resuming medicated feed operations. U.S. v. Syfrett Feed Co., Inc., No. 17-14038 (S.D. Fla., order entered May 4, 2017). The court entered the decree after the U.S. Food and Drug Administration (FDA) filed a complaint alleging the company failed to adequately identify and store the drugs it used or prevent contamination of drugs and feeds as well as mislabeled and misbranded feeds. According to the complaint, 17 horses had to be euthanized after eating the company’s horse-pellet food. Syfrett manufactures feeds for cattle, poultry, pigs, sheep, goats and exotic animals, but has agreed to discontinue production of the horse feed connected to the animal deaths. “Animal feed manufacturers that fail to comply with labeling and good manufacturing requirements for medicated animal feeds jeopardize…
Bumble Bee Foods, LLC has agreed to plead guilty to one felony count for its role in a conspiracy to fix prices of shelf-stable tuna and will pay a minimum $25 million fine. U.S. v. Bumble Bee Foods LLC, No. 17-CR-249 (N.D. Cal. May 8, 2017). According to the U.S. Department of Justice, Bumble Bee conspired with other seafood companies and their executives to inflate prices for canned and pouch tuna. Two Bumble Bee executives have already pleaded guilty to criminal charges; details appear in Issue 625 of this Update. “Today’s charge is the third to be filed—and the first to be filed against a corporate defendant—in the Antitrust Division’s ongoing investigation into price fixing among some of the largest suppliers of packaged seafood,” Acting Assistant Attorney General Andrew Finch said in a May 8, 2017, press release. “The division, along with our law enforcement colleagues, will continue to hold…
The U.S. Department of Agriculture (USDA) has delayed the effective date of a final rule amending organic livestock and poultry requirements and requests additional public comment. The effective date of the rule has been postponed from May 19, 2017, to November 14, 2017. Interested parties may submit written comments by June 9, 2017. Issue 634
The U.S. Senate has confirmed Scott Gottlieb to lead the Food and Drug Administration (FDA) in a 57-42 vote. Gottlieb previously served as a deputy FDA commissioner and an official at the Centers for Medicare and Medicaid Services during the George W. Bush administration. Among Gottlieb's critics are senators who expressed concern over his connections with the pharmaceutical and medical device industry, but Gottlieb has promised to divest himself from several companies and recuse himself from decisions involving those companies for one year. See New York Times and Washington Post, May 9, 2017. Issue 634
