Have regulators become deadly slow with tainted food alerts?

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT
Posted June 20, 2016, at 7:44 a.m.

Consumers are “at risk of injury or death.” That’s the kind of headline you’d expect to see in tabloids and on the talking head interview shows.

However, the above quote came from investigators for the Inspector General at the U.S. Department of Health and Human Services. They were referring not just to the commercially produced foods that made people sick but also to the slow pace of recalling tainted foods.

Those recalls are supposed to be handled by the Food and Drug Administration, or FDA. But the investigators found that, even after foods had been determined to pose health hazards, in some cases the agency was slow to force recalls.

Auditors had looked at 30 voluntary recalls from October 2012 to May 2015. They issued what’s termed a “rare alert” about two mandated recalls, saying “consumers remained at risk of illness or death for several weeks after FDA knew of potentially hazardous food.”

The Food Safety Modernization Act of 2011, or FSMA, gave the FDA the power to force companies to recall tainted products; it has used that power only twice, both times in 2013.

Recalls of salmonella-tainted pet food and adulterated dietary supplements came months after FDA learned of the problems.

Investigators also were troubled by two voluntary recalls. The first case occurred in 2014, when salmonella turned up in nut butter. The investigators say 165 days passed from the time the problem surfaced to the date the manufacturer issued a recall. There were 14 illnesses reported in 11 states.

Later that year, a listeria outbreak was traced to cheese products. The alert said it took 81 days to complete a series of recalls; at least nine people became ill.

George Nedder, who led the audit, was blunt. “I think the time that these recalls took were problematic, absolutely.”

The Center for Science in the Public Interest, or CSPI, has taken FDA to task over all voluntary recalls. Senior food safety attorney David Plunkett called on FDA to use the authority in FSMA to issue recalls, instead of letting manufacturers issue recalls voluntarily. Plunkett said,

“Unfortunately, based on the agency’s actions to date, the FDA hasn’t done much to implement those recall provisions and doesn’t appear to take informing consumers much more seriously [than some manufacturers] did,” he said.

The FDA fired off a news release following the rare alert. It stated that while lengthy delays happen in a minority of cases, such delays are still “unacceptable.” The release said the FDA is taking “concrete steps” to speed the pace of recalls.

“These steps include the establishment of a rapid-response team made up of agency leaders and the introduction of new technologies to make the process even swifter,” it stated.

The release did not indicate how those new technologies will operate.

In an agency blog, the FDA’s Dr. Stephen Ostroff and Howard Sklamberg wrote that deadlines are needed, but they won’t all necessarily be short. “The time needed to collect evidence can vary, but to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market,” they wrote.

Leaving contaminated food on store shelves is what concerned the auditors in the first place. We’re anxious to see FDA’s future recall record. See our blog for links to FDA recall information.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

Editor’s note: Consumer Forum will not be published the week of June 26. It will return the week of July 3.

New food-labeling rules aim to make Americans less fat

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT

Posted Aug. 30, 2015, at 3:12 p.m.

The expert in statistics in his field at the U.S. Centers for Disease Control and Prevention said we need to think of diabetes as an iceberg.

Roughly 29 million Americans have diabetes, mainly Type 2, which is closely linked to weight issues. However, the CDC’s Edward Gregg said about 28 percent of adults with diabetes don’t know they have it, while another one-third of all adults are considered at high risk for diabetes.

The undetected cases represent the part of the iceberg that’s under water.

Experts say three factors account for the country’s increasing obesity problem: larger portion sizes, greater sugar intake and less exercise. The U.S. Food and Drug Administration is taking aim at the first of those factors.

Click image for additional FDA resources

The FDA is proposing new rules for companies listing the contents of their packaged foods. The Nutrition Facts Label first appeared 20 years ago. Last March, the FDA began the long process of changing it. The agency hopes consumers’ knowledge will grow in three broad areas:

— Understanding the science: New labels will contain information about “added sugars,” update values of sodium dietary fiber and vitamin D and list amounts of potassium and vitamin D, now declared “nutrients of public health significance.” You’ll still see “total fat,” “saturated fat” and “trans fat” on labels, but “calories from fat” will disappear. The FDA’s reasoning: “type of fat is more important than the amount.”

— Serving size and per package labels: The ways many of us eat and drink today have changed since serving sizes first were set two decades ago. New labeling rules require that packaged foods normally eaten in one sitting be labeled as a “single serving” and nutrient information be listed for the whole package. Some packages that may be consumed either in one sitting or multiple sittings will need “dual column” labels; those will indicate “per serving” and “per package” calorie and nutrient information.

The FDA has little bit of wiggle room on the serving size issue. “By law, the label information on serving sizes must be based on what people actually eat, not on what they ‘should’ be eating,” its website states.

— Updated design: Calorie counts and serving sizes will be more prominent, and the percent daily value of ingredients will move to the left, so it’s read first. The percent daily value, or %DV, tells consumers how much of certain ingredients they get from that food in the context of a daily diet.

Food manufacturers have not been idle. The Grocery Manufacturers Association and Food Marketing Institute have been actively promoting voluntary front-of-label nutrient listings. The industry’s Facts Up Front website, factsupfront.org, suggested at the time the program was announced that “manufacturers may also include information on one or two nutrients to encourage,” a less robust revealing of information than the FDA label rules would require.

Not everyone loves the timing of FDA’s proposed changes. Back in 2010, the Center for Science in the Public Interest called on the agency to require more prominent counting of calories and revealing the nutrient content of realistic serving sizes. In a letter to FDA last year, the center urged action to prevent “the possible unintended consequence that some consumers view serving sizes as portion recommendations.”

If FDA’s goal is to get Americans to eat less, four studies cited in the journal Appetite suggest the opposite. In one study, 78 percent of participants thought “serving size” meant the amount of food that can or should be consumed at a sitting. Taken together, the writers say the studies “suggest that the proposed nutrition facts label’s increased serving sizes may lead people who use this information as a reference to serve more food to themselves and others.”

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

 

Legal questions swirl about off-label use of medications

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT

Posted Aug. 23, 2015, at 1:38 p.m.

Maine is among the states that will share in a $71 million settlement of the lawsuit against drug manufacturer Amgen.

Click image to see other Off-Label decisions on the DOJ site

The states bringing the suit alleged Amgen promoted biologic medications Aranesp and Enbrel for off-label uses. Their complaint said the company promoted the use of Aranesp for longer periods than the U.S. Food and Drug Administration approved.

The complaint also charged that Amgen claimed Aranesp could fight anemia caused by cancer without having either FDA approval or scientific research to support that claim.

The complaint said the company also promoted Enbrel as effective in treating mild plaque psoriasis; the FDA has approved use of the drug only to treat chronic-moderate to severe plaque psoriasis. The complaint also charged that Amgen overstated the length of time Embrel was effective in treating psoriasis.

The settlement was announced last week by several state attorneys general. In a statement, Amgen said the settlement resolves some of the same matters as in a 2012 settlement with the federal government. Under the settlement with the states, Amgen did not admit any wrongdoing or liability.

Maine also was a party to the December 2012 settlement. A U.S. Department of Justice news release at that time said the company paid $612 million to resolve lawsuits under the False Claims Act and $150 million in criminal penalties and forfeiture.

In its statement sent to Northeast CONTACT, Amgen said, “separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters.”

The company added it has a “strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law.”

The company also says all Aranesp-related conduct that riled regulators took place during the years 2002 and 2007; it says all Enbrel-related conduct happened between 2004 and 2011.

Over the years, pharmaceutical companies have handed over billions of dollars to settle claims of misbehavior. Federal regulators don’t want drug company reps talking to doctors about off-label uses of drugs; manufacturers have maintained they should be able to have such conversations, as long as they are truthful.

In May, Amarin Pharma filed suit against the FDA, saying it had a constitutional right to share information with doctors. Lawyers for the company say they believe it is the first time the FDA has been sued pre-emptively over the free speech issue.

Floyd Abrams, attorney for Amarin, put it this way in an interview with Business Day: “If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information.”

Dr. Michael Carome of the advocacy group Public Citizen holds the opposite view.

“If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process,” Carome said.

If it goes that far, a court might rule either broadly or narrowly, making an outcome tough to predict. Consumers can best protect themselves by carefully reading the data sheets that come with their prescription meds. If what your doctor tells you doesn’t match the intended uses in the instructions, start asking questions.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

Be Wary of “Autism-Treating” Products – WABI-TV Morning News

Video of Russ and Joy talking about several products that the FDA warns claim to offer treatment or prevention for Autism, however, more often than not, the products simply do not live up to their descriptions.   FDA warning.

BOTTOM LINE: If it is an unproven or little-known treatment, no matter who endorses it, talk with your healthcare professional before using.

FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare

FDA NEWS RELEASE

Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.

The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.

“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”

These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users of the recalled devices, who may include consumers and first responders, should contact Philips Healthcare   for more information.

An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.

Check serial number of your HeartStart device

 http://www3.medical.philips.com/resources/hsg/docs/en-us/custom/aedActionk1.asp

Protect Yourself Against Tick-Borne Disease

Food and Drug Administration issues Consumer Update

Different kinds of ticks present in the U.S. may be infected with bacteria, viruses and parasites that can be transmitted to people and cause at least 10 diseases. While there are treatments approved by the Food and Drug Administration (FDA), prevention is the easiest, cheapest and most effective approach to combat these serious, sometimes fatal diseases.

Some disease-bearing ticks are the size of a poppy seed. Steps to prevent infection include:

• When walking in grassy, wooded areas that are tick-prone, use an insecticide that is effective against ticks and cover up with long shirts and long pants tucked into socks.
• Ticks must stay attached for more than 36 hours to transmit the parasite, according to the Centers for Disease Control and Prevention (CDC), so a full body check soon after being outdoors in a tick-prone area, even a suburban lawn, is urged.
• Taking a shower within two hours of being in an area with ticks has been shown to be helpful and provides a good time to check for ticks on your body.
• When checking for ticks, include hard-to-see areas such as between toes, between legs and on the head.
• Remove any ticks with pointed tweezers, grabbing ticks by their mouth parts, close to your skin.

Commonly called a “deer tick,” this tick can transmit Lyme disease and a malaria-like disease called babesiosis. When in the larvae stage it is the size of a poppy seed, so checking your body for ticks requires close examination. (Click image for print version of report)

 

Lyme disease and Rocky Mountain spotted fever are the two best-known serious diseases transmitted through tick bites in the U.S. Each year since 2002, about 20,000-30,000 people in the U.S. have been diagnosed with Lyme disease. During that same time period, between 1,400 and 2,500 cases of Rocky Mountain spotted fever have been reported each year.

More recently, health officials have documented the emergence of babesiosis, a disease caused by single-cell parasites called Babesia. The parasites are carried by the same kind of ticks that carry Lyme disease.

Young, healthy adults infected with Babesia may have no symptoms, mild symptoms or flu or malaria-like symptoms. However, Babesiosis can be severe or even fatal among the elderly, newborns and those with weak immune systems. It is treated with a combination of FDA-approved antibiotics and anti-malaria medicines.

“Public awareness is critical, because most cases of babesiosis can be prevented by avoiding tick bites,” said Mark O. Walderhaug, Ph.D., an author of a study of babesiosis among the elderly. Walderhaug is the associate director for risk assessment in FDA’s Center for Biologics Evaluation and Research (CBER).

 

Sometimes free advice is the best kind

CONSUMER FORUM

By Russ Van Arsdale, Executive Director, Northeast CONTACT

Posted Feb. 02, 2013, at 6:50 p.m.

Take my advice. It’s free.

Some skeptics might say free advice is worth what you pay for it. But in some cases, the best choice is the free stuff.

That’s the case with a number of consumer publications from the federal government. Here are a few examples of free information that are well worth knowing.

The Food and Drug Administration (FDA) says parents should not give teething children under age two any meds containing benzocaine. It has been linked to methemoglobinemia, a rare but serious condition that reduces blood’s ability to carry oxygen. Visit www.fda.gov and search “benzocaine.”

Whether you’re looking for a job or checking on your credit, you can get your credit report for free by calling Annual Credit Report at 1-877-322-8228. Those rocking TV ads might make you think you need their services, but this free call tells you how to get your free report from each of the three major reporting services every year. (Really smart consumers get a report every four months by making rotating requests among the three.)

If a telemarketer calls about a contest or promotion, you don’t have to pay a fee or buy anything to enter. You can read about the Telemarketing Sales Rule (http://www.consumer.ftc.gov/articles/0199-prize-offers) to learn what the callers can and cannot do.

If you’re interested in doing your banking online, the Federal Deposit Insurance Corp.
(www.fdic.gov, search “online banking”) tells you how to:

1. Confirm that an online bank is legitimate and that your deposits are insured
2. Keep your personal information private and secure
3. Understand your rights as a consumer
4. Learn where to go for more assistance from banking regulators

A handy pamphlet called the Consumer Information Catalog lists dozens of publications filled with helpful info. Most are available free to download at www.publications.usa.gov. Many of the print versions also are free, while some cost a few dollars. Twenty-five federal agencies sponsor the assembly of the catalog. Here are a few highlights:

Federal and postal job information is always free, but some scam artists try to trick you into paying for it. A concise, two-page guide (http://publications.usa.gov/USAPubs.php?PubID=246) steers you away from their traps.

“It’s all natural,” claims the ad…but is it safe? Learn about health scams at the publications website by searching “6071.”

There are 20 things young people need to know to live financially smart lives. The President’s Advisory Council on Financial Capability lists them (http://publications.usa.gov/) and search “832”).

The Federal Citizens Information Center (you may recall the “Pueblo, Colorado” ads on TV) gets information out in a variety of ways. It publishes the Consumer Information Catalog four times a year, and it publishes a Consumer Action Handbook yearly. You can email through the website, answers.usa.gov, or call 1-800-FED-INFO (1-800-333-4636), from 8 a.m. to 8 p.m., Monday through Friday.

Your tax dollars support these resources; use them.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

A few simple steps to ensure your food is safe to eat

CONSUMER FORUM

By Russ Van Arsdale, executive director, Northeast Contact

Posted Aug. 12, 2012, at 11:42 a.m.

When we bring home canned goods from the supermarket, how many of us clean the lids before opening the cans?

It’s an easy step that health officials say can head off a lot of potential misery. A can may have been dusted recently in the store, but it may be covered by airborne germs and bacteria. Opening that dirty lid can let the contaminants fall right onto your food.

Another often neglected safety step is washing of food itself. Bacterial outbreaks traced to cantaloupe prompted warnings about washing the rinds in hot, soapy water before cutting; failing to wash allows bacteria to be spread inside when the knife goes through the rind.

The U.S. Department of Agriculture and Food and Drug Administration have produced six guides for people who need to be especially careful to prevent foodborne illnesses. These include people with weakened immune systems (cancer patients, those with HIV or AIDS), diabetics, older people, pregnant women and transplant recipients. Find the guides athttp://www.foodsafety.gov/poisoning/risk/index.html.

These are what FDA and USDA say that they are — guides, not comprehensive lists. People should check with their doctors for individual guidance on their conditions.

Some general hints apply to everyone, regardless of other health issues:

Make wise food choices

Uncooked fruits and vegetables are more likely to contain high levels of bacteria. So are some animal products (raw milk products, raw or undercooked eggs, raw meats, fish, shellfish and their juices). Luncheon meats and deli-type salads (without preservatives) prepared on site in a deli-type establishment may also be riskier than many other foods.

Careful shopping can help cut risks

Put raw packaged poultry, meat or fish in a plastic bag before putting it in your shopping cart, so it won’t drip on and contaminate other foods. Buy refrigerated shell eggs; if your recipe calls for raw eggs, buy pasteurized refrigerated liquid eggs. Be aware of sell-by dates. Don’t buy dented, bulging or cracked cans.

Transport food safely

Pick up perishable goods last, and plan to go straight home after checking out. Always refrigerate perishables within two hours of picking up groceries (one hour if the outdoor temperature is 90 or above). In hot weather, you can take a cooler with ice or frozen gel packs to transport food safely.

Prepare your food safely

Always have clean hands, work surfaces and utensils. Prevent cross-contamination; keep the juices of raw meats, seafoods, poultry and eggs away from ready-to-eat foods. Clean up with paper towels; if you use cloth towels, wash them often in hot water. Clean surfaces with a mild solution of unscented chlorine bleach (one tablespoon to a gallon of water).

If you think you’ve been affected by a foodborne pathogen, do the following:

• Consult your physician immediately; if you develop symptoms of infection, seek medical advice or treatment right away.

• Preserve the remaining food by wrapping it, labeling it “DANGER” and freezing it. The remainder could be analyzed to help determine the source of the outbreak and help others.

• Save all packaging and all identical unopened products.

• Contact your local health department.

The state of Maine lists food safety recalls at www.maine.gov/agriculture/qar/. To order the at-risk booklets, call the USDA Meat and Poultry Hotline at 1-888-MPHOTLINE (1-888-674-6854) or email mphotline.fsis@usda.gov or fsis.outreach@usda.gov.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s  nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer 04412, visit necontact.wordpress.com or email contacexdir@live.com.

More retailers pull formula after infant death | The Portland Press Herald / Maine Sunday Telegram

More retailers pull formula after infant death | The Portland Press Herald / Maine Sunday Telegram.
AP

COLUMBIA, Mo. — Several more national retailers have joined Wal-Mart Stores Inc. in pulling a batch of powdered infant formula from their shelves after a Missouri newborn who consumed it apparently died of a rare bacterial infection, the companies said today.

Officials at Supervalu Inc., Walgreen Co., Kroger Co. and Safeway said they have removed 12.5-ounce cans of Enfamil Newborn with the lot number ZP1K7G from various stores across the country as a precaution until federal health officials complete tests on the formula.

Ten-day-old Avery Cornett died Sunday after getting sick several days earlier in the southern Missouri town of Lebanon. Preliminary hospital tests indicated he died of a rare infection caused by bacteria known as Cronobacter sakazakii.

The source of the bacteria that caused the infection hasn’t been determined, but it can be found in dried milk and powdered formula as well as naturally in the environment and in plants such as wheat and rice.

“Out of an abundance of caution, we are removing the formula from certain stores,” SuperValu spokesman Mike Siemienas said today. “We will hold these products from sale until we receive additional guidance from regulatory authorities and the manufacturer.”

Retailers under the Supervalu corporate banner that pulled the product include Shaw’s, a New England grocer; Shop ‘n Save in St. Louis; Jewel-Osco in the Chicago area; Acme supermarkets in New Jersey and Philadelphia; Farm Fresh in Virginia; and some Albertson’s in southern California.

Kroger officials said they withdrew the formula from properties in Arizona, Indiana, New Mexico and the mid-Atlantic region. Kroger spokesman Keith Dailey said the company was able to remove most of the questionable batch from its warehouses and distribution centers before they were sent to retail outlets.

Officials with Walgreen Co. did not indicate how many stores are affected, or their locations, while the affected Safeway stores were primarily in the Chicago area, a company spokeswoman said.

Wal-Mart earlier this week announced its decision to pull the product from more than 3,000 stores nationwide. Avery’s parents bought their formula from a local Walmart in Lebanon, which is 160 miles southwest of St. Louis along Interstate 44.

A second infant in Missouri fell ill late last month after consuming several different types of powdered baby formula, but that child recovered, health officials said. The state health agency in Illinois, where the child lives, is investigating that case.

The Food and Drug Administration does not believe there is any connection between the two cases, spokeswoman Siobhan Delancey said.

The FDA, the Centers for Disease Control and the Missouri Department of Health are investigating the circumstances surrounding Avery’s death. Delancey said today that test results won’t be available until next week.

Investigators have collected samples of both liquid and powdered formula used by Avery’s family as well as unopened formula purchased at stores, including the Lebanon Walmart.

Formula manufacturer Mead Johnson Nutrition Co. said earlier this week that tests showed the batch was negative for the bacteria before it was shipped. A company spokesman did not respond to several requests for additional comment today.

The company told investors it plans to retest saved samples from the recalled batch, but the company did not undertake its own recall.

Wall Street investors reacted warily to the news, with shares of Mead Johnson falling a second straight day today amid investor concerns.

Enfamil statement

Liquid Acetaminophen for Infants concentration changes require caution

Consumer Updates: Know Concentration Before Giving Acetaminophen to Infants.

Read FDA alert

FDA has issued a Drug Safety
Communication (www.fda.gov/Drugs/
DrugSafety/ucm284741.htm) with more
information for consumers about
how to avoid confusion and potential
dosing errors with the different concentrations
of liquid acetaminophen.