Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually. Continue Reading New Legislation Gives More Time for Medical Device Reporting

On April 25, 2017, the U.S. Food and Drug Administration (FDA) again delayed the deadline for restaurants and grocery stores to implement new calorie labeling rules. Originally set for May 5, 2017, the agency pushed back the deadline a second time, now requiring compliance by May 2018.

However, the delay may have come a little too late. Delaying compliance less than 10 days before the deadline provides little help to businesses that have already worked to comply. And uncertainty still remains as to what the labeling rules will be when compliance is required. Continue Reading Three Ways to Deal with the FDA Calorie Labeling Delay

This month, food industry trade groups called on the Food & Drug Administration to halt its new food labeling law requiring food establishments to publish the calorie content of menu items.

Organizations like the National Grocers Association (NGA) and the National Association of Convenience Stores (NACS) continue to argue against the law. The major reason: costs. Not only the costs they’ll incur to implement it, but the long-term costs to remain compliant may be even higher. And research continues to show that menu labeling does not change consumer behavior. Continue Reading Is Counting Calories a Cost or a Benefit?

Food labeling litigation increased significantly last year, with many consumer groups alleging that products were misleadingly labeled and violated U.S. Food and Drug Administration labeling requirements. Consumers targeted phrases like “all natural,” “preservative-free,” or having “no preservatives.”

But FDA rules are unclear as to what these terms mean, which will likely spur more labeling litigation in 2017. Here we look at three main reasons for the anticipated increase in litigation. Continue Reading Food Fight: More Labeling Litigation in 2017

Earlier this month, the Food and Drug Administration (FDA) banned 19 chemicals found in antibacterial hand and body washes. Included in this list is triclosan, a widely used ingredient in antibacterial soap.

The FDA’s new rule has been in the works for nearly four decades. The FDA proposed its first triclosan regulation in 1978 but never moved forward. Then, in 2013, the FDA called for a re-evaluation of over-the-counter antibacterial products. It asked companies to conduct additional studies and provide information on the safety and effectiveness of their antibacterial products containing any of one of 22 different ingredients. Continue Reading Anti-Anti-Bacterials?

We wrote last month about the challenges facing Chipotle, a favorite restaurant of many Americans. Now another industry leader is facing similar challenges. Whole Foods Market Inc. has had a tough few years. Most recently, the Food and Drug Administration, in a series of crackdowns, told the industry’s leading company to clean up its act.

On June 8, the FDA issued a warning letter to the co-CEOs of Whole Foods, John Mackey and Walter Robb. The letter stated that the health food chain had 15 days to address the “serious violations” the FDA found while inspecting the company’s Massachusetts ready-to-eat food preparation plant in February. Continue Reading Truly Whole Foods? The FDA Thinks Not

In April 2016, we posted about the lawsuit brought by environmental food and safety groups, along with fisherman trade associations, to reverse the FDA’s approval of a genetically engineered (GE) salmon. The complaint alleges that the FDA failed to evaluate how the GE salmon will impact the environment and that the farmed salmon will inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .” Continue Reading GE Salmon: What’s Really at Steak

The FDA soon will regulate e-cigarette makers and distributors. The rules present new hurdles for manufacturers of existing e-cigarette products as well as future products. The new “deeming regulations” restrict youth access to e-cigarettes and extend certain regulations that apply to traditional tobacco products to e-cigarettes.

On May 5, 2016, the U.S. Food and Drug Administration announced its regulatory authority over e-cigarettes. Rules aimed at restricting youth access are effective as soon as August 2016. While the announcement did not come as a surprise—the FDA proposed regulations over two years ago—many in the industry argue that the FDA has overstepped its authority. Continue Reading FDA Extends Regulation of Tobacco Products to E-Cigarettes

Last November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption. Continue Reading Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

On November 19, 2015, the Food and Drug Administration (FDA) approved as fit for human consumption a genetically engineered (GE) salmon. AquaBounty Technologies AquAdvantage Salmon has been modified to grow faster than non-engineered farmed salmon. This marks the first time the FDA has authorized the sale of a genetically engineered animal as food.

Because the FDA determined that there are “no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon,” AquAdvantage will not need to label the fish as genetically modified. The FDA further found that approving the GE salmon would have no negative environmental impact. Continue Reading FDA Approves First Genetically Engineered Animal for Human Consumption