fda

Whistleblower Claims Major Baby Formula Company Used Defective Packaging

Whistleblower Claims Major Baby Formula Company Used Defective Packaging

The business pages are lighting up this morning with the news that baby formula biggie Mead Johnson Nutrition — makers of Enfamil — is being bought by Reckitt Benckhiser (whose brands include baby-stopping Durex condoms) for $16.6 billion, but we’re more interested in a new whistleblower lawsuit from a former Mead Johnson executive who claims the company ignored concerns about defective packaging and fired her for trying to get the problem addressed. [More]

Karen Chappell

A Supplement Company Sued Over Research It Didn’t Like… And Lost

Unlike FDA-approved medications, makers of dietary supplements are not required to demonstrate that their products are safe or effective. That shouldn’t stop independent researchers from doing their own tests to find out if a product works or is dangerous, but when one Harvard professor tried to do just that, supplement makers tried to shut him up.. [More]

Feds: Drug Company Delayed Cheaper Generics By Flooding The FDA With Paperwork

Feds: Drug Company Delayed Cheaper Generics By Flooding The FDA With Paperwork

Given that a brand-name prescription drug stands to lose a significant chunk of its market share once a lower-price generic becomes available, you can understand why a drug company would want to do anything it can to delay the cheaper alternative, even if you disagree with their intentions. We’ve seen companies accused of paying millions to stave off competition through alleged “pay for delay” deals, and we’ve also seen examples of “product hopping” to prevent competitors from entering the field. Now here’s another method for keeping generics off the market: allegedly flooding the Food and Drug Administration with pointless paperwork. [More]

David Lifson

Cookie Dough Company Behind Multiple Ice Cream Recalls Shuts Down

Where does the cookie dough in your favorite brand of ice cream come from? For numerous brands, the answer is Aspen Hills, a company in Iowa that sells frozen cookie dough for fundraisers and bulk frozen dough to ice cream makers. To be accurate, the answer was Aspen Hills. [More]

FDA Once Again Finds Elevated Levels Of Belladonna In Some Hyland’s Homeopathic Teething Tablets

FDA Once Again Finds Elevated Levels Of Belladonna In Some Hyland’s Homeopathic Teething Tablets

Your infant is in pain from sore gums, and you want to do something to ease that pain, so maybe you consider a homeopathic treatment, with its heavily diluted active ingredients. What you may not know is that this seemingly innocuous teething tablet might contain unsafe levels of potentially dangerous belladonna. [More]

Kai Brinker

Restaurants Sorting Out Weird Calorie Issues Before Menu Rules Go Into Effect

When your salad comes with dressing and croutons, should a menu board calorie count include those toppings? Does a restaurant have to calculate and post the calories in a seasonal item like an eggnog latte? Restaurants and vending machine operators only have a few months to figure this out before the Food and Drug Administration’s calorie-count requirement becomes mandatory. [More]

Mike Matney

Sales Of Antibiotics For Farm Animals Continues To Increase, Despite FDA Guidance

Three years ago, the Food and Drug Administration — in response to growing concerns about the spread of antibiotic-resistant bacteria — issued long-delayed guidance to the pharmaceuticals industry, asking drugmakers to voluntarily stop selling antibiotics to farmers solely for the purpose of growth-promotion in cows, pigs, and chicken. And while sales of these drugs have indeed slowed, the latest FDA report shows that they are still on the rise. [More]

House ‘Freedom Caucus’ Asks Trump To Undo 232 Rules On Net Neutrality, Tobacco, Nursing Homes & Ceiling Fans

House ‘Freedom Caucus’ Asks Trump To Undo 232 Rules On Net Neutrality, Tobacco, Nursing Homes & Ceiling Fans

What’s on your wish list this holiday season? For the few dozen members of the House of Representatives Freedom Caucus, the hope to see President-elect Donald Trump undo or revise more than 200 federal rules involving everything from tobacco to food labels to ceiling fans to your constitutional right to bring a lawsuit against your credit card company. [More]

Ben Schumin

USDA Asks Meat, Dairy Companies To Replace Confusing Expiration & Sell-By Labels With “Best If Used By” Date

Though almost every food item you buy at the supermarket has some sort of expiration date — under the headers of “Sell By,” “Use By,” “Use Before,” “Best Before,” among others — printed on the packaging, the truth is date labels are largely voluntary and determined by the food producers. If handled properly, most foods are perfectly safe to eat after whatever date is on the label, but stores and consumers throw away an inordinate amount of food every year simply because that date has passed. In an effort to reduce food waste, the federal government is hoping to encourage meat and dairy producers to all use the same phrase: “Best If Used By.” [More]

Steven Depolo

GNC Agrees To Improve Efforts To Keep Illegal Dietary Supplements Out Of Its Stores

When you buy a dietary supplement, you never know quite what you’re getting, because supplement manufacturers don’t have to prove to the Food and Drug Administration that their products work — or are even safe — before putting them on the market. GNC, the world’s largest dietary supplement retailer, has now agreed to try to ramp up efforts to ensure that the products it sells are safe and legal. [More]

Adam Fagen

Philip Morris Applies To Bring Heated-Up Tobacco Sticks To U.S.

You might remember that a few months ago, we shared some interesting smoking news: that Philip Morris was working on a new product that’s somewhere between an e-cigarette and an old-fashioned tobacco one. Instead of lighting tobacco on fire, users would heat it up in a special device, inhaling a vapor instead of smoke. The company plans to apply for FDA approval for the system, seeking approval to sell it as a healthier alternative to cigarettes. [More]

Sabra Recalls Hummus Over Listeria For Second Time In Two Years

Sabra Recalls Hummus Over Listeria For Second Time In Two Years

What’s your favorite flavor of hummus — is it garlic? Maybe roasted red pepper? How about Listeria monocytogenes? The bacteria might not be a popular flavor, but for the second time in less than two years*, Sabra Dipping Co. is recalling some of its products over concerns they may be contaminated with the pathogen.” [More]

Chaz Dean

Judge Gives Initial Approval To $26M Settlement For Claims That WEN Products Caused Hair Loss

In July, we heard that the Food and Drug Administration was investigating reports of hair loss, balding, itching, and rash associated with using celebrity stylist Chaz Dean’s hair care products, sold by a company called WEN. Now, a federal judge in Los Angeles has given preliminary approval to a $25 million settlement that resulted from a class-action lawsuit more than 200 customers filed against the company. [More]

ronnyg

Nutella’s Makers Want To Convince FDA That Chocolate Spread Isn’t Just For Dessert

When you think of sweet, hazelnut chocolate spread, are you imagining eating it for breakfast or for dessert? If you’re in the latter camp, you agree with the current stance of federal regulators. The makers of Nutella are now trying to make the case, however, that the spread should be considered more of a breakfast item. [More]

FDA

Deadly Bacterial Infection Linked To Machine Used During Heart Surgeries

Non-tuberculosis mycobacteria are among the germs that just are just sort of everywhere and don’t do much harm to people. The exception, though, is when they gain access to a person’s chest cavity or an artificial heart valve, and can be deadly. The bacteria get there by hitching a ride from a piece of surgical equipment, and patients generally aren’t warned that this is a risk during operations involving the heater-cooler machine. [More]

Pediatricians, American Cancer Society Take FDA To Court Over Delayed Graphic Warning Labels On Cigarettes

Pediatricians, American Cancer Society Take FDA To Court Over Delayed Graphic Warning Labels On Cigarettes

It’s been more than seven years since the Family Smoking Prevention and Tobacco Control Act became law, directing the Food and Drug Administration to bolster warnings on tobacco labels and to create graphic warning images to be printed on cigarette packaging. Even though the U.S. Supreme Court rejected the tobacco industry’s challenge to these labels in 2013, they have yet to materialize. In an attempt to force the FDA’s hand, a coalition of doctors, public health advocates, and anti-smoking groups have filed a lawsuit against the government. [More]

pjpink

Makers Of E-Cigarettes And Pricey Cigars Want To Avoid FDA Approval And Regulation

Until earlier this year, the Food and Drug Administration didn’t have authority to regulate some new or unusual smokeable products that have been growing in popularity, like premium cigars, hookah tobacco, vaping products, and e-cigarettes. However, the industries behind these products are fighting regulation with lobbyists, hoping to do away with the new rule. [More]

Scott Akerman

FDA Rules: You Can’t Sell “Anti-Bacterial” Hand Soap With Triclosan Anymore

After more than half a decade of various proposals, investigations, and dithering, the FDA today has announced that it’s changing the rules. 19 active ingredients in your hand soap — most notably including triclosan, until recently very common — are going to be heading off the market.

[More]