A federal court in New Jersey has, for a second time, requested supplemental briefing before approving a stipulated final order for permanent injunction and other equitable relief in the Federal Trade Commission’s (FTC’s) action against a company that allegedly marketed açai-berry weight-loss products with “fake” news reports and deceptive claims. FTC v. Circa Direct LLC, No. 11-2172 (D.N.J., order filed June 13, 2012). Among other matters, the court seeks FTC’s views on whether the agency has shown it was likely to succeed on the merits “without an admission of liability by the Defendants and with no evidentiary submissions before the Court.” The court also requests additional briefing on whether it “may consider the lack of an admission by the defendants in its public interest analysis under the [FTC Act].” When the parties submitted their first supplemental briefs, FTC Commissioner J. Thomas Rosch submitted a letter indicating that, in his view,…
Category Archives U.S. Government and Regulatory Agencies
A federal court in Florida has denied the Federal Trade Commission’s (FTC’s) request that it modify a stipulated final order resolving a 2006 dispute with Garden of Life, Inc. over purportedly unsubstantiated representations that its products could treat a range of serious diseases and their symptoms. FTC v. Garden of Life, Inc., No. 06-80226 (S.D. Fla., filed May 25, 2012). The parties had agreed that the company could make such claims if supported by “competent and reliable scientific evidence,” defined in the stipulated final order as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Claiming that the company was continuing to deceive consumers and that “the Stipulated Final Order has failed to…
The Food and Drug Administration (FDA) has notified Representative Edward Markey (D-Mass.) that it has accepted his petition seeking to prohibit the use of bisphenol A (BPA) in canned infant formula. If the agency is able to complete its scientific review, it will file his petition in the Federal Register within 90 days seeking public comment on whether the industry has actually abandoned this use of the chemical, the ground on which Markey sought the ban. As noted in Issue 433 of this Update, while FDA has confirmed the chemical’s safety for continued use in food-packaging materials, the American Chemistry Council has asked the agency to prohibit its use in polycarbonate bottles and sippy cups, contending that industry no longer uses BPA in these products. Markey’s petition echoed that rationale in relation to infant-formula packaging. According to a news source, the “abandonment” focus allows government to “sidestep the debate over…
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has extended until June 14, 2012, the comment period for a proposed rule that would amend regulations governing the importation of live bovines and other animal products with regard to bovine spongiform encephalopathy (BSE). Under the proposed rule, APHIS would adopt World Organization for Animal Health criteria that identify a country’s BSE risks as negligible, controlled or undetermined, bringing U.S. import regulations in line with international health standards. APHIS has pushed back the deadline to allow “interested persons additional time to prepare and submit comments.” Additional details about the proposed rule appear in Issue 432 of this Update.
A federal court in New York has determined that the Food and Drug Administration (FDA) arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of proceedings to withdraw approval from certain uses of antibiotic drugs in livestock. Nat. Res. Defense Council v. FDA, No. 11-3562, (S.D.N.Y., decided June 1, 2012). The ruling follows the court’s March 2012 grant of summary judgment to the plaintiffs on their first claim for relief. Additional information about that ruling appears in Issue 432 of this Update. The most recent ruling relates to the third claim for relief, that is, whether FDA violated the Administrative Procedure Act when it denied the two petitions “requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals.” The court first determined that it had subject matter jurisdiction over the claim, disagreeing with FDA’s assertion that its November 2011 decision…
The Food and Drug Administration (FDA) has rejected a Corn Refiners Association (CRA) petition urging the authorization of “corn sugar” as an alternate name for high-fructose corn syrup (HFCS). According to FDA’s May 30, 2012, response, CRA had asked the agency (i) “to amend the generally recognized as safe (GRAS) affirmation regulation for HFCS (21 CFR 168.11) to designate ‘corn sugar’ as an optional name for HFCS”; (ii) “to eliminate ‘corn sugar’ as an alternate name for dextrose”; and (iii) “to replace all references to ‘corn sugar’ with ‘dextrose’” in the GRAS regulations for corn sugar (21 CFR 184.1857). The trade association had apparently argued, among other things, that consumers confused by the name “high-fructose corn syrup” “incorrectly believe that HFCS is significantly higher in calories, fructose and sweetness than sugar.” In rejecting the petition, FDA countered that its regulations define sugar as “a solid, dried, and crystallized food; whereas…
A coalition of advocacy organizations has reportedly agreed to dismiss as moot its lawsuit seeking an order requiring the Food and Drug Administration (FDA) to respond to its 2006 petition asking the agency to regulate products containing nanomaterials. Information about the lawsuit appears in Issue 422 of this Update. The organizations, including Food and Water Watch and the Institute for Agriculture and Trade Policy, apparently indicated that while the agency has rejected some of their key proposals, FDA has formally responded to the petition. FDA has said that it will not regulate nanomaterials as new substances, but will evaluate them based on their effects on foods, drugs and cosmetics. See Capital Press, May 18, 2012.
An administrative law judge (ALJ) has upheld some of the Federal Trade Commission’s (FTC’s) allegations that POM Wonderful violated federal law by making deceptive claims in some advertisements that the company’s pomegranate juice and related products treat, prevent, or reduce the risk of heart disease, prostate cancer and erectile dysfunction. In re: POM Wonderful LLC, No. 9344 (FTC, decided May 17, 2012). The ALJ’s initial decision is deemed the decision of the FTC 30 days after it is served on the parties, unless appealed or placed on FTC’s docket on its own motion. According to the ALJ, some, but not all, of POM’s ads could be interpreted as containing an “implied claim” that the company’s products treat, prevent or reduce the risk of some diseases and that “these effects were clinically proven.” The ALJ also determined that (i) “the appropriate level of substantiation for claims that a product treats, prevents,…
The Food and Drug Administration (FDA) has announced a public meeting titled “International Capacity Building with Respect to Food Safety.” Scheduled for June 19, 2012, in Washington, D.C., the meeting will highlight “FDA’s comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.” Under the auspices of the Food Safety Modernization Act, the capacity-building plan seeks input from food industry representatives, federal and foreign government officials, consumer organizations, and other stakeholders. The plan seeks (i) “[r]ecommendations for bilateral and multilateral arrangements and agreements, including providing for responsibilities of exporting countries to ensure food safety”; (ii) “[p]rovisions for secure electronic data sharing”; (iii) “[p]rovisions for mutual recognition of inspection reports”; (iv) “[t]raining of foreign governments and food producers on U.S. requirements for safe food”; (v) “[r]ecommendations on whether and how to harmonize requirements under…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a notice requiring inspectors to make establishments aware of how to comply with a May 8, 2012, final rule on misbranded meat and poultry. The rule requires establishments to prepare and maintain recall procedures, notify FSIS within 24 hours when adulterated or misbranded meat and poultry products that could harm consumers have entered the marketplace and document their Hazard Analysis and Critical Control Point system food safety plans. The final rule was discussed in Issue 439 of this Update.
