FDA News

CVS Takes Action on Cough Products With Phenylephrine Amid FDA Scrutiny

CVS Health has announced the removal of specific oral cough and cold products featuring phenylephrine as the sole active ingredient from…

FDA Warns CVS, Others Against Selling Unapproved Eye Products

The U.S. Food and Drug Administration (FDA) has issued warnings to eight companies, including CVS Health Corp and Walgreens Boots Alliance,…

Cold Pills Could Be Yanked off the Shelf. An FDA Panel Just Ruled Some of Them Don’t Work.

A Food and Drug Administration (FDA) panel has unanimously ruled against the effectiveness of phenylephrine, a commonly used decongestant found in…

2,000 Barnacle-Covered Wine Bottles Worth Hundreds of Thousands of Dollars Destroyed After California Company Illegally Aged Them in the Ocean

Around 2,000 bottles of wine worth hundreds of thousands of dollars were destroyed after a wine company, Ocean Fathoms, was found…

Schumer asks FDA to investigate Logan Paul’s PRIME energy drink

U.S. Senator Chuck Schumer has asked the Food and Drug Administration (FDA) to investigate Logan Paul’s PRIME energy drink, citing concerns…

Should retailers and restaurants post calorie info no matter what the FDA decides?

Should retailers and restaurants post calorie info no matter what the FDA decides?

While the U.S. Food and Drug Administration is holding up rules requiring businesses that sell prepared foods to post signage with calorie counts, some chains have decided to display the information anyway. Would foodservice companies that post calorie counts see a business benefit from displaying that information?

Calorie counts reach retail and grocers aren’t happy

Prepared meals have been a burgeoning opportunity in recent years for supermarkets and c-stores, but new FDA requirements that stores display calorie count information could dilute the payback. How will requirements that stores display calorie counts impact the prepared meals opportunity for grocers and c-stores?

Nutrition facts label getting a makeover

In its first overhaul in 20 years, the FDA is planning a significant update of its nutrition facts panel, featuring more realistic serving sizes, and more prominently highlights calories. Should the food industry and retailers support or seek to prevent the changes?

E-Cigarette Use on Rise Among Kids

A new study by the Centers for Disease Control and Prevention shows that the percentage of high school students who tried an e-cigarette rose from under five percent in 2011 to 10 percent last year. Should limits be placed on the advertising of e-cigarettes and their in-store display?

FDA Investigates Whether Energy Drinks Caused Deaths

Energy drinks manufactured by Monster Beverage Company have been linked to five deaths in the past year, according to reports submitted to the Food and Drug Administration. What should retailers currently selling energy drinks do, considering the alleged links between the beverages and adverse health effects?

FDA’s New Wrinkle on Nanotech Research

Although the Food and Drug Administration (FDA) has said in the past that it doesn’t believe nanotechnology is “inherently unsafe,” there are still questions over potential health effects. Are the new studies on the safety of nanotechnology likely to have a significant effect on product development and sales for manufacturers and retailers?

Allegra to Make Rx to OTC Switch

Some of the biggest “new” product introductions in HBC over the years have been products that were moved from prescription-only status to over-the-counter (OTC). The newest popular drug to go the Rx to OTC route is Allegra. Will sales of Allegra be on par with previous Rx to OTC switches?

Some in GOP Want to Scrap Food Safety Bill

Some GOP members believe America can do without The Food Safety Modernization Act, though the bill had wide support of food industry groups and members of both parties voted in large numbers to pass it. Do you think the benefits of funding The Food Safety Modernization Act outweigh the negatives of not funding it?

Safety as Well as Environment Causing Concerns Over Bottled Water

Debate and doubts about bottled water have been growing for some time but in two far-flung areas, official actions are under consideration. Would more information about source and treatment influence consumers in their purchase of bottled water?

FDA: Offspring of Cloned Cattle May Be in Food Supply

The U.S. Agriculture Department has asked that clones continue to be held out of the market until January. It did not make the same request of the offspring of clones. The result is that offspring of some of the 600 clones in the U.S. may already be in the food supply. What impact will news that offspring from cloned animals may be in the food supply have on consumer confidence?

FDA Says Baby Bottles with BPA are Safe

Stores are already pulling containers with bisphenol A (BPA) off the shelves but the Food and Drug Administration (FDA) is saying that those steps may not be necessary based on available scientific evidence. Do retailers need to “err on the side of caution” when it comes to products that may possibly be harmful to consumers even if there is no definitive scientific evidence to support those concerns?

Rx COOL

Problems with drug imports in recent years, most notably contaminated heparin from China that resulted in the deaths of 19 individuals, has led to growing calls for the government to mandate country of origin labeling (COOL) for pharmaceuticals. What would you say is the level of confidence that American consumers have in the combined safety and effectiveness of prescription medicines sold in retail pharmacies today? Is a country of origin labeling requirement for active ingredients in pharmaceuticals something the retail industry should support?

FDA to Okay Meat, Milk from Clones

The technology is there to clone livestock and now the Food and Drug Administration is prepared to formally endorse the sale of meat and milk from these animals (and their offspring) for human consumption. The question is whether consumers will be buying when its time to make the sale. Will consumers get over their unease about food and milk from cloned animals like they have when other new food technologies have been introduced in the past? What position should you take if you are a food retailer?

U.S. and China Reach Deal to Safeguard Food Imports

China has signed agreements that promise to safeguard exports from that country including allowing American officials onsite access to Chinese factories so they may inspect food and ingredients destined for the U.S. market. How successful do you expect the new agreements between China and U.S. to be in assuring a safer supply of food and ingredients to the American market?

Drug Ads Booming

A study released last week found that the pharmaceutical industry’s direct-to-consumer advertising increased more than 300 percent in the past 10 years, while regulatory scrutiny of the ads’ claims has declined. According to its findings in the August 16 issue of the New England Journal of Medicine, the FDA sent fewer letters warning drug companies that commercials were overly minimizing risks or exaggerating the effectiveness of the drugs despite the rise in ads. Do you think more regulatory oversight is needed over the advertising content of drug ads?

Counterfeits Causing Real Damage in Human Terms

Fake pharmaceuticals, toothpaste, infant formula, extension cords and batteries are just a few of the products that have made their way into unsuspecting consumers’ homes with deadly consequences. The increase in fake goods hitting markets in North America has been staggering and low budgets and a lack of personnel have made it nearly impossible to keep these potentially dangerous items out of the hands of consumers. What should retailers and suppliers be doing to combat counterfeiting?

Is it Time for the FDA to Regulate Tobacco?

An editorial in the Daytona Beach News-Journal is pretty direct in making its point. “It boggles the imagination that the FDA can pull a drug like Celebrex after it is linked to 10 deaths, but lacks the power to mitigate the hazards of tobacco.” Should oversight for tobacco reside at the Food and Drug Administration instead of the Department of Agriculture?

Melamine Contamination Links Port Security to Food Safety

The U.S. is an importing nation and it simply is too onerous a process to inspect everything that comes into the country’s ports. That’s why food ingredient shipments are allowed in, with port authorities assuming companies on the receiving end of the shipment will do the necessary testing to make sure the product and, ultimately, consumers are safe. As now appears evident, that “system” did not work in the recent case that saw pets become sick and in 16 cases die from pet food tainted with wheat gluten containing melamine. Is the current system sufficient to protect the safety of the imported food supply to the U.S.?

FDA is Okay with Cloned Meat

The report was long (678 pages) but, in the end, the Food and Drug Administration’s findings were easily summed up in a single sentence: Meat and milk from cloned animals is safe for human consumption. The FDA’s report doesn’t yet approve the sale of food from cloned animals but is the first step towards what at this point seems a done deal. Where do you see the cloned livestock issue going?

Groups Debate Regulating Functional Food Claims

A number of consumer groups are looking for the government to do a better and quicker job of evaluating the health claims made by a variety of functional food products, reports Ad Age. Right now, it is argued, the myriad claims made by products in the marketplace have resulted in a great deal of consumer confusion. Are consumers confused about the health claims made by functional foods?

Debating How Best to Protect Nation’s Food Supply

An editorial in The New York Times says it is time for a single agency to be responsible for the safety of the nation’s food supply. The paper argues that 15 separate agencies have been identified by the United States Government Accountability Office of responsibility in varying degrees for carrying out the task of protecting the food Americans eat. Would a single agency responsible for food safety be more effective handling the task than the multi-agency approach currently used?

FDA Isn’t Cloning Around with Meat and Milk

The Food and Drug Administration (FDA) announced on Tuesday it is moving closer to approving the sale of meat and milk from cloned farm animals in grocery stores. As could be expected, there are many unhappy about the eventuality of products from cloned animals hitting supermarket shelves. Will there be widespread acceptance by consumers of meat and milk from cloned animals?

FDA Issues Caveat Emptor Warning on Canadian Pharmacies

According to an FDA warning, consumers should not buy prescription drugs from web sites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada. There have been reports these companies have sold counterfeit versions of prescription medicines to consumers in the U.S. What do you see as the issues related to consumers going online to purchase less expensive prescription medicines?

Coming Up With a Plan for Plan B

According to the new FDA ruling, stores may now sell Plan B to women 18 or older without a prescription. A prescription is still required for girls 17 and younger. Actual over-the-counter (OTC) sales of the product will not happen until the FDA approves the packaging and insert warnings for the product. Now that Plan B is finally set to go OTC, what does that mean in practical terms for retailers?

McD’s Wants Government to Tighten Up BSE Safeguards

A group that includes McDonald’s is calling on the government to do more to protect animals and people from bovine spongiform encephalopathy (BSE), also known as mad cow disease. According to the group, new safeguards put into place by the government two months ago fall “woefully short” in keeping potentially infected animal feed away from cattle. Do the FDA’s rules for safeguarding the meat supply from possible BSE infection go far enough?

Editorial: Perspective Needed on OTC or Behind the Counter

Rachelle Cohen, an editorial writer for The Boston Herald, writes that things may be getting out-of-hand when politicians are requiring that boxes of Sudafed be sold from behind the counter while allowing pharmacists to sell Plan B, the emergency contraceptive, to women without a prescription. Do you agree with Rachelle Cohen that common sense is often times set aside when it comes to deciding what products get placed behind the counter or are sold OTC?

Thompson: Food Supply Easy to Attack

The outgoing Health and Human Services Secretary Tommy Thompson says there is reason for alarm. The nation’s food supply is far from safe. Last week, in remarks made after announcing his resignation, Mr. Thompson said, “For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do.” What is your perspective on the safety of the nation’s food supply and steps that need to be taken to secure it?

RFID: The 70 Percent Solution

The recent move by the Food and Drug Administration and pharmacy manufacturers to reduce counterfeiting and tampering with prescription medicines using radio frequency identification (RFID) should only be viewed as a partial solution, according to Gartner’s principal analyst, Jeff Woods. Are the limitations of RFID such that manufacturers and retailers should only be looking to it as a partial solution to their supply chain and inventory control challenges? What other options should the parties be considering in addition to RFID?

States Defy FDA on Rx Imports

The states of Illinois and Wisconsin have launched a new program, I-SaveRx, to help residents without insurance buy cheaper prescription medicines from Canada, Ireland and the U.K. In doing so, the states are defying a Food and Drug Administration (FDA) regulation prohibiting the importation of prescription medicines. What are the implications of legal imports of drugs from overseas for U.S. pharmacies? How should the retail industry deal with this issue?

Senators Say It’s Time To Import Rx Drugs

A General Accounting Office (GAO) report provides the evidence that it’s time to lift the ban on importing prescription medicines from Canada, say key Republican and Democratic senators. In light of the GAO study and other evidence, isn’t it time that retail pharmacists in the U.S. began to lobby Congress and the Bush Administration to legalize the import of prescription medicines from Canada?

Morning-After Pill Not Going OTC

The Food and Drug Administration (FDA) has gone against the recommendations of its own scientific advisors by deciding to withhold approval for the over-the-counter (OTC) sale of the so-called morning-after or Plan B pill. What are your thoughts on the FDA’s decision concerning Plan B?

FDA’s New Anti-Obesity Plan Gets Mixed Reaction

The Food and Drug Administration unveiled its proposals to fight the growing rise of obesity in the country with new voluntary labeling guidelines that would make it easier for consumers to count calories and get nutritional information. What are your thoughts on the FDA plan? Can American consumers rely on the food industry to voluntarily make the changes being requested by the FDA?

Critics: Three Percent Inspections Not Enough

Critics say the Food and Drug Administration only inspects two to three percent of the produce coming into the country and that’s not nearly enough to safeguard the nation’s food supply. Does the U.S. system of food inspection need to be overhauled? How?

Republicans Want to Abstain From Morning After Pill

A group of 49 House Republicans have written to President Bush asking him to order the Food and Drug Administration to reject a proposal to approve the “morning after” pill for over-the-counter (OTC) sales. What are your thoughts on the morning after pill being approved for sale OTC?

FDA Issues Warning on Mercury in Fish

The Food and Drug Administration has issued an advisory on the health risks associated with the consumption of certain types of fish including canned albacore tuna. Do stores selling fish identified for containing high mercury levels have the moral obligation to provide a caution at the point of purchase to customers at risk?

Customs Joins Food Protection Efforts

In case you missed it, US Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) signed a Memorandum Of Understanding (MOU) last week paving the way for Customs agents to begin inspecting food imported into the United States. Will the decision to let Customs agents inspect imported food help improve the safety of the food supply in a meaningful way? What are your thoughts on the government’s efforts to protect the nation’s food supply?

State Wants to Buy Canadian Drugs

Govenor Rod Blagojevich of Illinois wants the federal government to allow states to import cheaper prescription medications from Canada to deal with rising prices, reports Reuters. He urged the U.S. Food and Drug Administration (FDA) to reverse its “misguided” stance opposing states importing lower priced drugs. What is the answer to the Canadian prescription import issue?

Label Policy Draws Praise and Criticism

The FDA has issued an announcement detailing the agency’s plan to ease the criteria for companies wishing to make health claims for products, according to the Washington Post. The Grocery Manufacturers Association (GMA) is calling it “an important step forward,” although it expressed reservations about some aspects of the announced plan. What are your thoughts on the FDA’s proposed policy changes for products making health claims?

FDA To Push For Drugs to Go OTC

The FDA wants to see the antihistamines, Allegra and Zyrtec, made available for OTC use, but the manufacturers, Aventis Pharmaceuticals and Schering-Plough, do not. The FDA has determined it needs to be “more proactive in recommending key potential switches.” Should the FDA have the authority to force “drugs over-the-counter against makers’ wishes”?

NFPA Opposes FDA Trans Fat Labeling Proposal

The NFPA contends that qualitative or quantitative consumer research is needed before deciding if the reference “Intake of trans fat should be as low as possible” should be included on product labels. What is your position on the FDA’s proposed trans fat labeling requirements?

Acetaminophen Overdose Warning Issued

Reuters Health reports that overdoses from products containing acetaminophen are responsible for 39% of acute liver failure cases in the US. Are accidental overdoses simply a consumer issue or is there more that manufacturers and/or retailers should be doing?

FDA Says Swedish Researchers May Be Right on Acrylamide

The report seven months ago that Swedish researchers had discovered high levels of potentially cancer-causing acrylamide in baked and fried foods was met with skepticism in this and other news sources and discussion forums. That may change now that the Food and Drug Administration (FDA) has announced t hat it has also found troubling levels of acrylamide in products such as french fries and potato chips. Will the FDA announcement have an impact on the food sales?

Segregation Hits the Produce Department

New federal guidelines stipulate that organic and non-organic foods shall be kept separated in stores, leading some to wonder if this will give either category of products a boost up. What has and will be the impact of the National Organic Program on grocery operations and consumer spending?

Oregon GMO Vote Not Needed, Says FDA

Genetically modified foods are just as safe as conventional foods and need no additional labeling, says the Food and Drug Administration (FDA) in a letter written to Oregon’s governor, John Kitzhaber. The FDA expressed its opposition to Measure 27 requiring labeling of products containing genetically modified organisms. What would the adoption of Measure 27 have on consumers, manufacturers and retailers?

Will the ‘Morning-After’ Pill Make the Rx to OTC Switch?

An article in The New England Journal of Medicine is calling for the Food and Drug Administration (FDA) to approve the so-called ‘Morning-After’ pill for over-the-counter distribution. Would the switch be a wise decision?