U.S. Representatives Frank Pallone Jr. (D-N.J.) and Rosa DeLauro (D-Conn.) have proposed legislation (H.R. 3984) that would require the Food and Drug Administration (FDA) to establish standards for arsenic and lead in fruit juices within two years. Titled the “Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012,” or the “APPLE Juice Act of 2012,” the proposal is designed to “protect children from harmful health effects of significant juice consumption,” the lawmakers said in a joint press release. Calling for lead and arsenic to be as strictly regulated in juice as they are in bottled water, the lawmakers said the bill came in response to a Consumer Reports investigation revealing “alarmingly high levels” of the toxins in apple and grape juice in New Jersey, New York and Connecticut. “We must ensure that the juices our children drink are safe, particularly when 70 percent of the apple juice…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has issued a report outlining eight proposals to make its “publicly available compliance and enforcement data more accessible and user-friendly.” Under the initiatives described in the report, FDA will explore different ways to (i) “improve data quality and facilitate more timely data disclosure”; (ii) expedite error reporting; (iii) “present its compliance and enforcement data graphically and better utilize mobile web applications”; (iv) “better integrate its compliance and enforcement data”; (v) improve the search capabilities of the inspections database; (vi) post additional data compilations or analysis; (vii) “better utilize social media”; and (viii) “provide appropriate context for the compliance and enforcement data that it discloses.” See Federal Register, February 1, 2012.
A federal court in Iowa has denied a motion seeking to preliminarily enjoin the Food and Drug Administration (FDA) from enforcing regulations prohibiting the interstate sale of raw milk. Farm-to-Consumer Legal Defense Fund v. Sebelius, No. 10-4018 (N.D. Iowa, decided January 23, 2012). The plaintiffs, who either produce or consume raw milk, filed their motion under the All Writs Act, claiming that FDA has taken enforcement actions against third parties in other jurisdictions while the plaintiffs’ lawsuit challenging the validity of the rules is pending and that such action usurps the court’s jurisdiction to decide whether the interstate sale of raw milk is legal. According to the court, “[t]he plaintiffs have not cited, and I have not found, any authority for the proposition that the first federal court to entertain a challenge to a federal regulation has the power to forestall enforcement of that regulation by a federal agency in other…
A U.S. Food and Drug Administration (FDA) official has declared seafood from the Gulf of Mexico safe for human consumption after 2010’s Deepwater Horizon oil spill. In December 2011, eight U.S. Senators urged the agency to “publicly and vigorously” defend the safety of Gulf seafood. In a January 11, 2012, FDA blog post, Deputy Commissioner for Foods Michael Taylor said that more than 10,000 seafood specimens were tested for polycyclic aromatic hydrocarbons (PAHs) after the spill and that PAH levels were “100 to 1,000 times below the levels which would raise a health concern.” Taylor added that FDA feels “confident that the levels that were set are safe and protect the health of anyone who eats seafood, including children and pregnant women.”
Putative class actions have been filed in New Jersey and California federal courts against Tropicana Products, Inc., alleging that the company misleads consumers by labeling and marketing its orange juice as “100% pure and natural,” when it actually “undergoes extensive processing which includes the addition of aromas and flavors.” Lynch v. Tropicana Prods., Inc., No. 11-07382 (D.N.J., filed December 19, 2011); Lewis v. Tropicana Prods., Inc., No. 12-00049 (E.D. Cal., filed January 6, 2012). Both plaintiffs seek to certify nationwide classes. The New Jersey plaintiff alleges unjust enrichment, breach of express warranty, violation of the New Jersey Consumer Fraud Act, and injunctive and declaratory relief. He requests compensatory, treble and punitive damages; prejudgment interest; restitution; injunctive relief; attorney’s fees; and expenses and costs of suit. The California plaintiff, who also seeks to certify a subclass of California consumers, alleges unjust enrichment; breach of express warranty; violation of the state Consumers…
The U.S. Food and Drug Administration (FDA) has issued a final rule prohibiting the extra-label use of cephalosporin antimicrobial drugs in livestock. Citing “evidence that certain extralabel uses… will likely cause an adverse event in humans,” the agency has specifically barred using cephalosporins (i) “at unapproved dose levels, frequencies, durations, or routes of administration”; (ii) “in cattle, swine, chickens, or turkeys that are not approved for use in that species (e.g., cephalosporin intended for humans or companion animals)”; and (iii) “for disease prevention.” The final rule, however, still permits the use of an older drug, cephapirin, while allowing veterinarians to oversee limited extra-label cephalosporin use “in cattle, swine, chicken, or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.” “We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account…
George Washington University Law Professor John Banzhaf has issued a press release highlighting recent action the Food and Drug Administration took against a food company that purportedly misbrands one of its products by declaring it “All Natural” while making the product with a synthetic chemical preservative ingredient. According to Banzhaf, the agency’s warning letter is “likely to lend support to and encourage an ever-growing number of major class action law suits being filed on these grounds, says the public interest law professor whose earlier movement to use legal action as a weapon against obesity apparently inspired these new legal actions.” He claims that The American Lawyer recognized how he started this litigation movement, noting in an article that he used the courts to address obesity, “just as he had earlier done in leading the use of legal action as a weapon against smoking.” Banzhaf further states, “The movement which Banzhaf started…
A federal court in Georgia has determined that it has personal jurisdiction over a Michigan food-packaging company that was sued as a third party defendant in litigation over a recalled baby food product. IPN USA Corp. v. Nurture, Inc., No. 11-501 (N.D. Ga., decided December 12, 2011). A Food and Drug Administration investigation apparently concluded that the third-party defendant (Liquid) had violated agency regulations on the manufacture of acidified and acid food products. While the baby food manufacturer (Nurture) allegedly sustained millions in damages in the recall, it was the packaging supplier (IPN) that brought the lawsuit against Nurture for breach of contract. According to the court, Liquid had sufficient contacts with Georgia for the court to exercise jurisdiction over the company. For purposes of packaging Nurture’s baby food, Liquid had purchased a machine, packaging supplies and other equipment from IPN’s Georgia-based entity, which referred a “significant number” of prospective customers…
The Office of Inspector General (IG) of the U.S. Department of Health and Human Services has issued a report that “identified significant weaknesses in FDA’s [the Food and Drug Administration’s] oversight” of its contracts for state inspections of food facilities. In recent years, FDA has increasingly shifted to the states its responsibility for conducting inspections, and has apparently “failed to ensure [in eight states] that the required number of inspections was completed,” “did not ensure that all State inspections were properly classified and that all violations were remedied,” and “failed to complete the required number of audits for one-third of the States and did not always follow up on systemic problems identified.” Based on an analysis of FDA inspection data and interviews with agency officials, the report, titled “Vulnerabilities in FDA’s Oversight of State Food Facility Inspections,” opens by noting that annually “128,000 Americans are hospitalized and 3,000 die after…
Eight U.S. Senators have urged the Food and Drug Administration (FDA) to “publicly and vigorously” defend the safety of Gulf seafood in the wake of last year’s oil spill. Led by Senator David Vitter (R-La.), the lawmakers signed a December 1, 2011, letter to FDA Commissioner Margaret Hamburg asserting that although “rigorous testing” has revealed that Gulf seafood is safe for human consumption, many consumers believe otherwise because of “misinformation and unscientific claims.” Vitter wrote a similar letter to Hamburg in November. The effort was prompted by opposing claims made by the Natural Resources Defense Council (NRDC), whose scientists assert that FDA’s safety thresholds for Gulf seafood “significantly” underestimate cancer risks from seafood contaminants. NRDC published a study in Environmental Health Perspectives concluding that “FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children.”
