Tag Archives: FDA

New Legislation Gives More Time for Medical Device Reporting

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 … Continue Reading

Is Counting Calories a Cost or a Benefit?

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: … Continue Reading

Food Fight: More Labeling Litigation in 2017

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 … Continue Reading

Truly Whole Foods? The FDA Thinks Not

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. … Continue Reading

GE Salmon: What’s Really at Steak

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 … Continue Reading

FDA Extends Regulation of Tobacco Products to E-Cigarettes

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 … Continue Reading

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

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. … Continue Reading

FDA Approves First Genetically Engineered Animal for Human Consumption

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 … Continue Reading

Hacking Health Care: When Cybersecurity Can Mean Life or Death

Millions of Americans rely on implantable medical devices to stay alive. These battery-operated devices communicate through wireless transmissions — and can be hacked like any other wireless device. For example, a wireless pacemaker regulates a person’s heartbeat and records the heart’s activity, and then transmits this information to doctors who can reprogram the pacemaker. The … Continue Reading

Peanut Butter Pick-Me-Up

Senator Chuck Schumer (D-NY) is again voicing concern about caffeinated foods. The latest in caffeine-laden food trends is a new caffeinated peanut butter which boasts the equivalent of two cups of coffee in two tablespoons of peanut butter. In a letter to the Food and Drug Administration (FDA), Senator Schumer urged the agency to investigate … Continue Reading

FDA Issues Final Guidance on Biosimilars

Shortly after approving the first biosimilar under the abbreviated approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the FDA has recently issued 3 final guidances regarding biosimilars. Biological products, or “biologics,” are pharmaceutical products created from biological sources. Unlike chemically synthesized pharmaceuticals, biologics are isolated from natural sources, and … Continue Reading

UPDATE: FDA Speeds Up the BMPEA Battle

In response to mounting pressure, the FDA issued warnings to five supplement companies last week regarding the risks associated with beta-methylphenethylamine, or BMPEA. BMPEA is widely used in weight loss and energy supplements, but has an ingredient similar to amphetamine. Supplement makers claimed that BMPEA was allowed in dietary supplements because it occurred naturally in a shrub … Continue Reading

Grocery Freezers Empty as Blue Bell Conducts Massive Ice Cream Recall

Last night, Texas-based Blue Bell Creamery announced a full, nationwide recall of all its products. This is a significant expansion of the recall Blue Bell began earlier this month after three deaths in Kansas from listeria – the first recall in the company’s 108-year history. The initial recall was limited to specific products, but was expanded … Continue Reading

Bodybuilder Beware: Study Raises Concerns About Speed-Like Substance in Supplements

Whether you’re a bodybuilder trying to lose that last percentage of body fat or an average person looking to lose a few extra pounds, weight loss supplements can offer a quick fix. But a number of popular fat-burning weight loss supplements may contain the chemical known as Beta-methylphenylethylamine (BMPEA), a stimulant recently criticized for its … Continue Reading

Lawsuits Fuel Debate About Powdered Caffeine

Two recent deaths allegedly resulting from the use of powdered caffeine has led to litigation and a public alert from the FDA, warning consumers of the dangers of the substance. One teaspoon of powdered caffeine is roughly equivalent to 25 cups of coffee. The product is not available in stores, but can be purchased in … Continue Reading

FDA Reopens Comment Period for Drug Labeling Rule

The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which … Continue Reading

The FDA Warns Common Medical Device May Spread “Super Bugs”

The Food and Drug Administration recently issued a “safety communication” warning that a common medical device used to perform procedures that over 500,000 Americans undergo annually, may put patients at risk for developing “super bug” infections.   The FDA communication, Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication, was issued on … Continue Reading

FDA Issues New Draft Guidance That May Ease Approval for Drugs to Treat Alcoholism

The FDA has issued new draft guidance that may make it easier for pharmaceutical companies to develop and market drugs to treat alcoholism.  The proposed guidance provides that the FDA may approve drugs that help patients improve their drinking behavior, even if the drugs do not help patients achieve complete sobriety.  The draft guidance is being issued consistent … Continue Reading

First FDA E-Cigarette Workshop Highlights Divisions in the Industry

Researchers, academics, public health advocates, and other stakeholders in the e-cigarette industry participated in the FDA’s first public workshop on e-cigarettes over two days in December 2014.  The workshop on e-cigarettes and other vapor products (sometimes referred to as Electronic Nicotine Delivery Systems, or ENDS) suggested that ongoing efforts to regulate these devices are aligning … Continue Reading

Food Safety Fears Prompt Proposed Overhaul of Federal Agencies

On the heels of a listeria outbreak associated with caramel apples and a similar proposal by two members of Congress, President Obama has proposed forming a single, centralized federal food safety agency. More than a dozen federal agencies now have authority over food safety issues, although the FDA currently holds the most responsibility. The various … Continue Reading
LexBlog