Category Archives U.S. Government and Regulatory Agencies

According to a new Animal Welfare Institute (AWI) report titled “Label Confusion: How ‘Humane’ and ‘Sustainable’ Claims on Meat Packages Deceive Consumers,” the U.S. Department of Agriculture (USDA) fails to verify the accuracy of label claims on most meat and poultry products sold in the United States. The report suggests that food label claims used on millions of meat packages lack “any apparent verification,  and AWI has asked USDA to require independent third-party certification. Noting that the use of animal welfare and sustainability claims has increased dramatically during the past decade as consumers become more aware of—and concerned about—the well-being of animals raised for food and the purported negative impacts of animal agriculture on the environment, AWI contends that the public’s interest in these claims makes them ripe for exploitation. During the past three years, AWI researched the USDA approval process for 25 animal welfare and environmental claims, such as…

Despite its seven-year investigation into jerky pet treats that may have killed more than 1,000 dogs and left thousands more ill, the U.S. Food and Drug Administration (FDA) “has still not been able to identify a specific cause for the reported illnesses or deaths.” According to an FDA news release, as of May 1, 2014, the agency had received more than 4,800 complaints of illness in pets that ate jerky treats made of chicken, duck or sweet potato. In its ongoing efforts to find a cause for the illnesses, FDA has partnered with the Centers for Disease Control and Prevention to conduct a study to determine whether sick dogs eat more jerky treats than healthy dogs do. Studies of the jerky treats revealed the presence of the antiviral drug amantadine, but “FDA does not believe that amantadine contributed to the illnesses because the known side effects or adverse effects associated…

U.S. Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), and Orrin Hatch (R-Utah) have sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg expressing “significant concern” about the agency’s use of draft guidance to, in their view, make “substantive policy changes.” Noting that draft guidance is “increasingly becoming default FDA policy” although it is issued for comment purposes only, the letter expresses a number of concerns, including that (i) FDA’s website does not differentiate between draft and final guidance; (ii) draft guidance is not revised, finalized or withdrawn in a timely manner; and (iii) the agency issues guidance that “does not take into account, or may even conflict with, the scientific community.” Specifically, the senators request that FDA provide a list of all Level I draft guidances, including the date issued and the timeline on which the agency plans to withdraw, revise or finalize each guidance,…

The U.S. Food and Drug Administration (FDA) has issued draft guidance intended to help the food industry prepare submissions for obtaining exemptions from the labeling requirements for major food allergens. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that food labels identify products containing major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans). Because an ingredient derived from a major food allergen may be modified to such an extent that it does not contain allergenic protein or does not cause an allergic response that poses a risk to human health, FALCPA apparently provides two processes through which manufacturers can obtain an exemption from this labeling requirement for a specific ingredient. An ingredient may be exempted through submission and approval of either (i) a petition containing scientific evidence which demonstrates that the ingredient “does not cause an allergic response that poses a…

With an aim to “improve public awareness of product identities by providing truthful and accurate labeling of meat and poultry products,” the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has submitted its final rule for labeling products that contain an “added solution” to the federal Office of Management and Budget for review. Observing that “without adequate labeling information, consumers cannot distinguish between raw meat and poultry product[s] that contain added solutions and single-ingredient meat and poultry products,” FSIS proposes that all meat and poultry products, raw or partially cooked, that contain at least a 3 percent saline or other liquid solution or marinade, bear a label stating that the product has been “enhanced” with solution. The agency estimates a one-time total cost to modify all federally inspected meat labels of about $80 million. Issue 523

Dubbing powdered alcohol “the Kool-Aid of teen binge drinking,” Sen. Charles Schumer (D-N.Y.) has called on the U.S. Food and Drug Administration (FDA) to supersede the Alcohol and Tobacco Tax and Trade Bureau (TTB) by banning a product known as Palcohol® before it reaches store shelves. Created by Lipsmark, LLC, Palcohol® first attracted media attention when TTB granted and then temporarily rescinded approval for its labels, citing a technical issue with the amount of powdered alcohol in each package. Additional details about Palcohol® appear in Issue 521 of this Update. Now Schumer has written a May 5, 2014, letter to FDA Commissioner Margaret Hamburg, asking the agency to work with TTB “to assess the potential public health concerns that arise by combining this product with food and beverages.” Pointing to a 1976 district court ruling and a memorandum of understanding that saddled both agencies with the responsibility to regulate alcohol,…

The Campaign for a Commercial-Free Childhood (CCFC) and Corporate Accountability International (CAI) published an April 25, 2014, letter to U.S.Department of Agriculture (USDA) School Programs Branch Chief Julie Brewer, criticizing a proposed rule that would require schools “to implement policies for the marketing of foods and beverages on the school campus during the school day consistent with nutrition standards for Smart Snacks.” According to the letter, the proposal not only gives a “green light” to food marketing in schools, but “opens the floodgates for many other types of marketing in schools.” Claiming that “the commercialization of childhood is linked to a host of problems facing children today that extend well beyond the consumption of unhealthy foods,” CCFC and CAI have asked USDA to acknowledge that “commercial-free school environments are preferable to those that allow marketing.” The letter also takes issue with the agency’s “Smart Snacks” program, alleging that the nutrition…

The U.S. Department of Agriculture’s (USDA’s) National Organic Program (NOP) has issued final guidance on the use of “Made with Organic” claims on product labeling. According to NOP, the guidance seeks to clarify “the following aspects of products in this labeling category”: (i) “composition”; (ii) “compliant organic labeling claims”; (iii) “organic and nonorganic forms of the same ingredient”; (iv) “percentage of organic ingredients statements”; and (v) “ingredients or food groups in the ‘made with organic’ claim.” Available through “The Program Handbook: Guidance and Instructions for Accredited Certifying Agents and Certified Operations,” the new policies reflect NOP’s current thinking on organic product labeling. In particular, “Made with Organic” products “must contain at least 70 percent organic ingredients, excluding salt and water”; “may contain up to 30 percent nonorganic ingredients,” provided any nonagricultural ingredient is allowed by the National List of Allowed and Prohibited Substances; and “must not contain any ingredient that was produced…

In a blog post, U.S. Food and Drug Administration (FDA) Chief Food Safety Inspector Michael Taylor said that the agency will not disrupt the current practice of breweries and food manufacturers selling or donating spent grains to farmers for use as animal feed. The proposed rule would have required breweries to dry, package and inspect spent grain before it could be given to cattle, which could have cost the brewing industry an estimated $50 million per year, according to Sen. Charles Schumer (D-N.Y.). Additional details appear in Issue 519 of this Update. FDA will still issue revised proposals on spent grains this summer, but Taylor said they will not include requirements that human food manufacturers establish separate animal feed safety plans and controls to cover their by-products. “The recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and thus is…

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued guidance for identifying, controlling and labeling allergens and other ingredients of public health concern through hazard analysis and critical control point (HACCP) plans, standard operating procedures (SOPs) or other prerequisite programs. Geared toward meat and poultry products, the guidance seeks to ensure “that product labels declare all ingredients, as required in the regulations, and that the product does not contain undeclared allergens or other undeclared ingredients.” In particular, the agency points to “a sustained increase in the number of recalls of FSIS-regulated products that contained undeclared allergens,” noting that such recalls are “preventable, as many have been due to ingredient changes, product changes, products in the wrong package, or products with misprinted labels.” In addition to establishing best practices for SOPs and HACCP plans, the recommendations clarify how to properly process, handle, store, and label a product…

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