FDA Resumes Inspections of Certain Foods during Government Shut Down

FDA Commissioner Dr. Scott Gottlieb announced this week that he was requesting furloughed federal employees to return to work and resume inspections of certain high-risk foods. Typically, the FDA conducts about 160 food inspections per week. Inspections have been halted since the federal government shut down and 40% of the FDA’s workforce was put on furlough. Dr. Gottlieb stated that he hoped that several hundred workers would return without pay to resume inspections of foods such as soft cheeses, seafood, some fruits and vegetables, baby…
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Federal Court Finds Issue of Fact on “Artificial Flavor” Label — Partially Grants Class Certification

Recently, the United States District Court for the Southern District of California granted partial certification to a class-action suit filed over alleged false advertising based primarily upon the labeling of “artificial flavors” in beverages manufactured by defendant Ocean Spray Cranberries, Inc. The plaintiff claimed that the labels on certain juice-based beverages falsely stated “No . . . artificial flavors” when in fact the beverages contained artificial flavoring chemicals (malic acid and fumaric acid) that simulate the advertised fruit flavors.   The plaintiff was seeking to certify…
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Seven Deadly(?) Substances: FDA Removes Seven Food Additives from Approved List Due to Cancer Risk

The FDA has revised its food additive regulations to block the use of seven synthetic flavoring substances in food products that may increase cancer risk in humans. Evidence submitted to the FDA by the Breast Cancer Fund, the Center for Environmental Health, the Center for Food Safety, and others, demonstrated that six of the synthetic substances caused cancer in lab animals under study conditions. The seventh flavor, styrene,  is being removed from the food additive list because it is no longer widely used by the…
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What Do We Know About Plant-Based Products & Dairy Foods – FDA Wants to Know

The FDA notes an emergence and expansion of plant-based products that are labeled in a manner that includes the names of dairy foods such as “milk” (i.e. “soy milk” and “almond milk”); “cultured milk” (i.e. “coconut kefir”); “yogurt” (i.e. “soy yogurt” and “almond yogurt”); and “cheese” (i.e. “vegan mozzarella cheese”).  You will often find these types of products located near or along with their dairy counterparts and in similar packaging.  However, the FDA notes these plant-based products may not have the same basic and essential…
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A Big Week of Changes in Cannabis Law

Despite continued animosity by U.S. Department of Justice regarding marijuana and marijuana-based products, at least one branch of the federal government decided that the time was right to approve the use of a drug made from cannabidiol. As many of you know from our earlier posts, U.K. company GW Pharmaceuticals Plc, created a drug to treat seizures associated with two types of epilepsy that typically affect children. After providing substantial evidence to the Food and Drug Administration (FDA), on Monday, June 25, 2018, the FDA…
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Pharma Opioid Suits Casting a Wider Net

Under both federal and state law, it is unlawful to advertise if the advertisement tends to mislead or deceive. States have enacted consumer protection laws to enforce and regulate such deceptive practices. In New York, under General Business Law §349, deceptive acts or practices in the conduct of any business, trade, or commerce, or in the furnishing of any service in the state, is declared unlawful. Over the years, the Federal Trade Commission has prosecuted many businesses accused of engaging in false and deceptive advertising.…
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Third Circuit Adopts Heightened Materiality Standard under False Claims Act

On May 1, 2017, the Third Circuit issued a decision in United States ex rel. Petratos v. Genentech Inc., 855 F.3d 481 (3d Cir. 2017) narrowing the ability of qui tam relators to show materiality under the False Claims Act (FCA). In essence, the court held that to be material, a misrepresentation or omission by a drug company must relate to the United States’ decision to pay a claim, not a doctor’s decision to prescribe a drug that would lead to a reimbursement claim…
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FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting…
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FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the…
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District Court Judge Denies Manufacturer of OTC Pain Reliever Summary Judgment Based on Preemption

Judge Lawrence Stengel of the United States District Court for the Eastern District of Pennsylvania denied summary judgment to the manufacturer of an over-the-counter pain reliever. The manufacturer had sought to dismiss the plaintiff’s fraud and fraudulent misrepresentation claims as preempted by federal law. The Food and Drug Administration (FDA) regulates how OTC drugs should be labeled and sold. The Federal Trade Commission regulates whether an OTC drugs advertising is misleading. In the case before Judge Stengel, the OTC manufacturer argued that the fraud claims…
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