Flu facts for expectant moms – National Consumers League

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Recent reports show that up to 30 percent of pregnant women who are infected with the H1N1 flu virus require hospitalization. And of the H1N1-related deaths reported in the United States, 6 percent of them – a disproportionately high percentage – are pregnant women. According to the U.S. Centers for Disease Control, “Getting a flu shot is the single best way to protect against the flu.” Yet many pregnant women are either hesitant to get a flu shot or have been unable to get vaccinated due to limited supplies.

The National Consumers League wants to make sure that expectant moms have the best information available, so they can make good decisions about protecting their health—and the health of their babies—and know where to go to get the care they need. The following is a fact-filled discussion featuring NCL executive director Sally Greenberg and, providing the answers, Dr. Annelise Swigert, a board certified Ob/Gyn and fellow of the American College of Obstetricians and Gynecologists.

Sally: What is H1N1 flu, also known as swine flu? And what is a flu vaccine?

Dr. Swigert: Every year, the public is faced with a seasonal flu which usually arrives in late fall. This year, the U.S. and many other parts of the world must deal with an additional flu called H1N1 or swine flu. H1N1 is a relatively new virus that was first detected in April 2009. It is contagious, spreading from person-to-person worldwide. Illness with H1N1 has ranged from mild to severe, including hospitalizations, and some deaths. Flu vaccines, given as a shot or inhaled through the nose, protect against contracting the disease.

Sally: Why is it important for women to be vaccinated for the H1N1 “swine flu”?

Dr. Swigert: H1N1 can cause serious complications during pregnancy. Pregnant women who are infected by H1N1 are more likely to end up in the hospital. A recent report showed up to 30 percent of pregnant women with H1N1 required hospitalization. Even if they are otherwise healthy, pregnant women who get the H1N1 virus can develop severe pneumonia and respiratory failure, deliver their babies early, or possibly miscarry. Of all the deaths related to H1N1, six percent have been in pregnant women, an unusually high percentage.

Getting the H1N1 vaccine while pregnant will continue to protect the baby after he or she is born. Studies on previous influenza vaccine use in pregnancy have shown more than a 60 percent decrease in serious illness in infants born to mothers who received the vaccine when they were pregnant.

Sally: Is the vaccine for the H1N1 flu safe for pregnant women and their babies?

Dr. Swigert: Yes, the H1N1 flu vaccine is safe for

pregnant women and their babies, and has been approved by the Food and Drug Administration. The H1N1 vaccine is the same as the seasonal flu vaccine with a slightly different strain of influenza. If H1N1 had been identified a few months sooner, it would have been the seasonal flu vaccine for 2009-2010. The seasonal flu vaccine has been safely given to pregnant women for more than 40 years. The vaccine can be given during any trimester of pregnancy and also postpartum, while breastfeeding.

As with all medication use in pregnancy, your doctor will review risk versus benefit. For most women, the benefit of getting the vaccine and preventing active infection from H1N1 far outweighs the extremely small risk of serious side effects.

Sally: Where can a pregnant woman get the vaccine?

Dr. Swigert: Pregnant women should start by contacting their Ob/Gyn or other primary health care provider if they don’t have access to an Ob/Gyn. The vaccine is available at many Ob/Gyn clinics, and those that don’t have it may be able to help their patients find it elsewhere. Community centers are now holding flu shot clinics for high-risk populations, such as pregnant women or those with certain chronic conditions, like asthma. Some employers will have the vaccine, especially those in health care fields. Always let the doctor or clinic know you are pregnant, as you’re in a high-risk group and should receive priority.

Sally: Is there any way the H1N1 vaccine could have been made more quickly?

Dr. Swigert: This year was particularly challenging because vaccine manufacturers needed to produce many millions of doses of both the seasonal flu vaccine and the H1N1 vaccine – simultaneously. As a result, production of the H1N1 vaccine is being completed in about half the time it usually takes. For the most part, pregnant women and other high-risk groups have been able to get vaccinated, and health officials believe enough vaccine will be available by the end of the year to safely vaccinate all those who wish to receive it.

In Europe, government regulators have approved the use of what are called “adjuvants,” additives that can be added to the vaccine supply to greatly increase its yield

or number of doses available. U.S. officials have not yet approved adjuvants, although many in the medical community believe they are a safe and effective way to expand the vaccine supply.

Sally: How is the vaccine delivered?

Dr. Swigert: The vaccine is available in two ways: an injection and an inhaled version. The injection contains a part of the virus that causes the immune system to make antibodies to protect the body from actual infection. The inhaled vaccine has the live virus that also causes the immune system to make antibodies. Both vaccines are safe and effective.

Pregnant women should receive the shot, and not the inhaled vaccine. Women who are postpartum or breastfeeding can receive either the shot or the inhaled vaccine. Only one injection is necessary to fully protect pregnant women from infection with H1N1.

Sally: Are there side effects?

Dr. Swigert: Some women have mild side effects such as soreness at the injection site or mild headache or body aches 2-3 days after the shot. These are not signs of infection or an allergic reaction, but signs that the immune system is responding as it should to the vaccine.

Women who have an allergy to eggs could have an allergic reaction to the shot and should not receive the vaccine. Serious reac­tions to the vaccine are very rare and occur in only one in every million women.

Sally: Have any unborn babies been harmed by the vaccine?

Dr. Swigert: The only danger to unborn babies is if their mothers get sick with the H1N1 virus. The vaccine is not dangerous, but getting the H1N1 virus is. Studies of pregnant women and their children who received the seasonal flu shot have shown no bad outcomes.

Sally: Will pregnant women who don’t get the vaccine risk getting sick?

Dr. Swigert: Pregnant women who do not get vaccinated risk becoming acutely ill with the H1N1 virus. Many of these women will have mild to moderate illness, but they risk possible complications such as pneumonia and respi­ratory failure. These complications cannot be predicted or prevented, even once the illness is diagnosed. Risks to unborn babies can include premature delivery and respiratory distress.

Sally: Does the H1N1 flu vaccine contain any additives that could interfere with a child’s development?

Dr. Swigert: Thimerosal, a preservative, is used in flu vaccines, including the H1N1 vaccine. Although thimerosal has never been scientifically proven to be harmful to children or pregnant women, due to public perception, vaccine manufacturers have produced preservative-free, single-dose syringes for use in pregnant women. These vaccines are more costly and time con­suming to produce than vaccines with thimerosal, and may not be available in all communities. Your clinic will be able to give you information on the vaccines they have available.

Also remember that because thimerosal has never been scientifically proven to be harmful to pregnant women or the fetus, injections using this preservative should be safe for use in pregnant women.

Sally: My friend gave birth a month ago. Should she get the vaccine now?

Dr. Swigert: Yes. Infants under 6 months of age are at extremely high-risk for complications from H1N1. By getting vaccinated not only will you decrease the risk of getting sick and giving it to your baby, but if you are breastfeeding, the baby will get protection from the illness through antibodies in the breast milk.

Sally: Is the vaccine safe for women who are breastfeeding?

Dr. Swigert: Yes. It is safe to receive either the shot or the inhaled vaccine while breastfeeding.

Sally: What if your family already had the flu this fall? Should expectant mothers still need to get vaccinated?

Dr. Swigert: Yes. Even if members of your family or you have had an influenza-like illness, it is still impor­tant to get vaccinated to protect you and your baby.

Sally: How can we avoid getting the flu?

Dr. Swigert: The best way to prevent the flu is to be vaccinated. Like many viruses, it is transmitted from person to person most commonly through coughing or sneezing. Other important ways to reduce the risk include: washing your hands often and thoroughly with soap, using alcohol-based hand sanitizers, and not touching your nose, eyes, and mouth.

Sally: What are the symptoms of the H1N1 flu?

Dr. Swigert: The two main symptoms of H1N1 are a fever of 100 degrees or higher, and cough and/or sore throat. Other symptoms may include headache, body aches, chills, runny nose, fatigue, diarrhea, and vomiting. Pregnant women should contact their doctor or clinic immediately if they experience any of these symptoms, as they will need to start anti-viral medication.

Sally: What should a pregnant woman do if she thinks she has H1N1? Should she take an anti-viral medication?

Dr. Swigert: H1N1 can be dangerous for a pregnant woman and her baby. Contact your doctor or clinic immediately if you have any symptoms. Treat any initial fever with acetaminophen (Tylenol), which is safe in pregnancy. Anti-viral prescription medications, such as Tamiflu, are recommended for pregnant women and safe to use.

Medication should be started within 48 hours of the onset of symptoms. Confirmation that the illness is the H1N1 virus is not necessary to begin treatment. A pregnant woman should follow her physician’s instruc­tions and should not delay seeking treatment under any circumstances.

Emergency care is necessary if a pregnant woman experiences difficulty breathing, chest pain or pressure, vomiting, dehydration, dizziness, confusion or loss of alertness. It is also important to contact your doctor if your symptoms have improved and then get worse again.

Sally: If a pregnant woman’s child or family member becomes sick with H1N1, should she avoid contact with the sick family member?

Dr. Swigert: If a family member becomes sick, a pregnant woman should contact her doctor immediately to be treated with anti-viral medication. In addition, families should have a plan to care for each other that protects pregnant mothers from the risk of infection. If others aren’t available to help care for a sick child, pregnant mothers should try to limit exposure by washing their hands often, throwing away dirty tissues, and avoiding touching their nose, mouth, or eyes as much as possible. Pregnant mothers may also wear surgical-quality face­masks if they must care for sick family members.

Sally: If a pregnant woman gets the H1N1 flu vaccine, does she need to get the seasonal flu vaccine too?

Dr. Swigert: Yes. The H1N1 flu vaccine will not protect against the seasonal flu. The seasonal flu is also a threat to a pregnant woman’s health – and the health of her baby. The seasonal flu should be treated with the same caution, care, and preventative measures as H1N1 flu.

Dental care key to health reform – National Consumers League

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Providing preventative health care is one of the most important strategies for lowering our nation’s health costs. We hear a lot about the 46 million Americans without health insurance, but rarely do we hear that more than twice that lack dental insurance.

The case for dental coverage is the same as for health care. People without health care coverage often get sick with illnesses that could be treated at far less cost if caught early. When it comes to dental care, kids with minor tooth problems may end up with dental disease for the rest of their lives. This can hurt their ability to stay in school or get a job. Adults with missing teeth find it hard to get jobs as well.

But poor dental health can also kill you. The Washington Post ran a story about Deamonte Driver, a 12-year old who died of complications stemming from a toothache that could have been cured by an $80 tooth extraction. Deamonte’s family had lost its Medicaid coverage, and few dentists would even take Medicaid patients anyway. Bacteria from the tooth spread to Demonte’s brain, leading to hospitalization and two operations. The total cost of the hospital care was about $250,000, and the hospital was still unable to keep him alive.

The National Consumers League, with our long history of work on health care, has joined with several other groups including the American Dental Education Association, the Dental Health Foundation, and Oral Health America, in a campaign to underscore the importance of including dental care in health care reform. The groups have sent an open letter to Congress asking for recognition of these facts:

  • Dental conditions become more serious and are more costly to treat without intervention.
  • Untreated dental disease can have fatal and costly consequences.
  • Access to dental insurance is extremely difficult for the nation’s poorest. Half of all states’ Medicaid plans provide no or extremely limited dental coverage.
  • 130 million Americans, including 16 million children and 80 percent of seniors, lack dental insurance coverage. This is more than twice the total number lacking basic health insurance.
  • Poor oral health can complicate diabetes; heart disease; pneumonia; and further study is needed to determine the documented link between gum disease and preterm low birth weight babies.

Having dental insurance can be the difference between simple tooth decay and losing your teeth, or the difference between a toothache and a serious operation. Dental care is preventive care; it saves our hospitals and taxpayers the high cost of treating life-threatening complications and helps poor and middle class people get and keep jobs.

 

Denied health claim? Appeal it! – National Consumers League

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Have you run into problems with your health plan? You’re not alone! Half of all consumers experience problems with them, but fewer than 1 in every 10,000 tries to fight, or appeal, when a claim has been denied. But appealing a denied claim works—maybe more often than you’d think!

Forty percent of people who file appeals with their health plan are successful. Ten percent of claims denied by a health plan turn out to be a simple mistake, and those are usually resolved quickly. When you find out that a medical service you’ve received (like a visit to the emergency room, a visit to an out-of-plan provider, or a test your doctor asked you to take) has been denied by your health plan, it is important to know your rights. The first denial by your health plan is not the final word, and there are processes in place to appeal these decisions.

NCL’s new brochure can help you be your own best advocate! By doing a little legwork, and following some basic procedures, you may be able to successfully appeal the decision and get the coverage you need for your claim. Download our brochure to learn a few basic steps to guide you in the process.

Consumer groups concerned about mechanically tenderized meat products – National Consumers League

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Following a December 24, 2009 recall of 248,000 pounds of mechanically tenderized steaks that sickened 21 consumers in 16 states, nine of whom were hospitalized, consumer groups are calling on the U.S. Department of Agriculture to require labeling identifying all mechanically tenderized meat products; to include these products in its sampling program; and to inform the public and restaurants about the need for adequate cooking of these products.

USDA’s Food Safety and Inspection Service, in conjunction with the Centers for Disease Control and Prevention, has linked the illnesses to mechanically tenderized steaks produced by National Steak and Poultry and distributed to restaurant chains.

Often used on less expensive cuts of meat to increase tenderness, mechanical tenderization is a process that inserts small needles or blades into a meat product, such as a steak or roast. These needles or blades can transfer any pathogens located on the surface of the product to the interior, increasing the risk to consumers if the product is not cooked to a high enough temperature to kill the pathogens.  FSIS estimates that over 50 million pounds of mechanically tenderized products are produced each month. Currently this product is unidentifiable to consumers or institutions.

Assuring adequate cooking temperatures for mechanically tenderized products is particularly important. USDA currently recommends that consumers cook beef steaks and roasts to 145°F while it recommends that consumers cook ground beef products to 160°F in order to kill any pathogens that may have been distributed throughout the product. The higher cooking temperature for ground beef products is warranted, given that ground products may have pathogens distributed throughout the product, not just on the surface.

Mechanically tenderized steaks and roasts present a similar risk to consumers because pathogens may not be just on the surface of the product. These products require higher cooking temperatures to ensure that all internal pathogens have been killed. This is especially important since many consumers prefer steaks cooked to rare or medium, which means the products are cooked to a temperature lower than 160°F.  Since mechanically tenderized products are not labeled, food preparers may be cooking these products to unsafe temperatures and putting themselves, their families and customers at risk of deadly foodborne illness.

In a June 2009 letter to USDA, consumer groups outlined concerns that mechanically tenderized products presented an unnecessary risk to consumers. The letter, signed by numerous consumer groups, urged USDA to issue labeling requirements for mechanically tenderized products and to develop educational materials for the restaurant industry and the public. To date, USDA has not responded to those requests.

These groups, along with NCL, Consumers Union, and S.T.O.P., Safe Tables Our Priority, recently urged USDA to take steps immediately to address this risk to the public. The groups specifically ask USDA to:

  • Require labeling that will allow all meat purchasersto clearly identify mechanically tenderized, non-intact meat products;
  • Develop an educational outreach campaign to inform the public and retail meat purchasers about the proper cooking and handling procedures necessary to reduce the risk of foodborne illness from mechanically tenderized meat products; and
  • Develop and implement a sampling program for the detection of E. coli O157:H7 in mechanically tenderized meat products.

Don’t waste your money-or your health-on counterfeit drugs – National Consumers League

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When shopping around for prescription medications, watch out for fakes! You could throw your money away on drugs that don’t work, or — even worse — get sick by taking counterfeits that aren’t what they pretend to be.

  • Counterfeit drugs may not have the same active ingredients as the real thing. They may also be produced in unsanitary conditions. Counterfeits could actually make you MORE ill.
  • Only buy prescription drugs from safe, reputable sources. Check unfamiliar sellers with your state board of pharmacy or the National Association of Boards of Pharmacy (NABP). Go to www.nabp.net, click on “Who We Are,” then “Boards of Pharmacy” for a list, or call 847- 391-4406. When buying online, look for Web sites displaying the NABP’s VIPPS seal, indicating that the pharmacy meets state and federal requirements.
  • Don’t be fooled by the packaging. Know the size, shape, color, taste, and side effects of the drugs you take, and examine new packages to make sure everything is right. If you notice anything different about the packaging or the actual medicine, alert the pharmacist and your doctor immediately.
  • Also report your suspicions to the U.S. Food and Drug Administration (FDA). If you bought the drug by mail, telephone, or in person, contact the FDA Medwatch program, 800-332-1088. To report counterfeit drugs purchased on the Internet, use the form at www.fda.gov/oc/buyonline/buyonlineform.htm or call the Medwatch number.
  • For more information from the National Consumers League about counterfeit drugs, visit fraud.org.

A consumer guide to dietary supplements – National Consumers League

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Dietary supplements, including vitamins, minerals, herbs and other botanicals, and amino acids, are used by a growing number of people in the United States. They’re available at drug stores, specialty stores, even gas stations! Some of these products have a long history as traditional remedies, especially many herbal and botanical products, but others, such as amino acids and enzymes are fairly new to the marketplace.

Dietary supplements have gained mainstream popularity and are sold in major grocery stores, pharmacies, convenience stores, and specialty shops, as well as through direct sales representatives, catalogs, and on the Internet.

NCL’s brochure, A Consumer Guide to Dietary Supplements, is intended to give you a better understanding of what dietary supplements are, the claims manufacturers can make about the products, and the information listed on the product labels. It also includes a glossary of commonly used terms, a list of questions to ask yourself and your health professional, and a resource section for additional information.

Foodborne illness making millions of Americans sick – National Consumers League

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Foodborne illness causes 76 million Americans to fall sick, 325,000 Americans to be hospitalized, and 5,000 Americans to die each year. Recent foodborne illness outbreaks linked to contaminated foods highlight the inadequacies of our current food safety system. Learn what groups like NCL are doing to help improve the safety of our foods.

According to the Centers for Disease Control and Prevention, foodborne illness causes 76 million Americans to fall sick, 325,000 Americans to be hospitalized, and 5,000 Americans to die each year. Recent foodborne illness outbreaks linked to contaminated peanuts, cookie dough, and spinach – along with news coverage of illness and death from contaminated ground beef – highlight the inadequacies of our current food safety system.

Outdated laws, insufficient authorities, and inadequate resources prevent the Food and Drug Administration from ensuring the safety of the food supply. For these reasons, the National Consumers League supports food safety reform and is doing its part as a member of the Make Our Food Safe Coalition (www.makeourfoodsafe.org) to convince Congress to enact improved food safety legislation this year.

Don’t waste your money – or risk your health – on counterfeit drugs – National Consumers League

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When shopping around for prescription medications, watch out for fakes! You could throw your money away on drugs that don’t work, or — even worse — get sick by taking counterfeits that aren’t what they pretend to be.

  • Counterfeit drugs may not have the same active ingredients as the real thing. They may also be produced in unsanitary conditions. Counterfeits could actually make you MORE ill.
  • Only buy prescription drugs from safe, reputable sources. Check unfamiliar sellers with your state board of pharmacy or the National Association of Boards of Pharmacy (NABP). Go to www.nabp.net, click on “Who We Are,” then “Boards of Pharmacy” for a list, or call 847- 391-4406. When buying online, look for Web sites displaying the NABP’s VIPPS seal, indicating that the pharmacy meets state and federal requirements.
  • Don’t be fooled by the packaging. Know the size, shape, color, taste, and side effects of the drugs you take, and examine new packages to make sure everything is right. If you notice anything different about the packaging or the actual medicine, alert the pharmacist and your doctor immediately.
  • Also report your suspicions to the U.S. Food and Drug Administration (FDA). If you bought the drug by mail, telephone, or in person, contact the FDA Medwatch program, 800-332-1088. To report counterfeit drugs purchased on the Internet, use the form at www.fda.gov/oc/buyonline/buyonlineform.htm or call the Medwatch number.
  • For more information from the National Consumers League about counterfeit drugs, visit Fraud.org.

Canned tomato products not so ‘fresh’ after all – National Consumers League

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The National Consumers League has again called on the Food and Drug Administration to renew its efforts to prevent consumers from being misled by deceptive labeling of processed fruit and vegetable products – this time in the canned tomato products industry.

Nineteen years ago, NCL persuaded the FDA to take a firm stand on prohibiting the use of the term “fresh” on any fruit or vegetable product that is reconstituted or remanufactured from concentrate. At that time, NCL asked that the use of the term “made from concentrate” or “reconstituted” be placed prominently on the front label of these products. FDA issued policy guidance designed to prevent the continued labeling misrepresentation of these products and took action against Ragu “Fresh Italian” Pasta Sauce and Citrus Hill “Fresh Choice” Orange Juice.

Since that time, according to Sally Greenberg, Executive Director of NCL, “the marketplace has become littered once again with false and misleading labels for products, for example, tomato products that are reconstituted from industrial tomato concentrate, pretending to be ‘made from fresh tomatoes,’ ‘packed in season,’ or ‘packed from vine ripened tomatoes’.”

In a 2009 letter to FDA, NCL asked that it issue a new guidance to industry setting forth the FDA’s enforcement policy regarding appropriate use of labeling claims that express or imply that a tomato product was packed or made from fresh tomatoes, and to enforce that policy rigorously. NCL also asked that all fruit and vegetable products reconstituted or remanufactured from concentrate be required to disclose this prominently on the label’s front panel. Greenberg stated, “Such a declaration would provide information that consumers need and want to make informed purchase decisions and would close out the clever word play.”

In a new letter to the FDA this April, NCL urged the agency to warn the food industry that claims implying that products are made from fresh ingredients when they are actually made from concentrate are deceptive under federal law. NCL also reiterated its 2009 request that FDA require that all fruit and vegetable products remanufactured from concentrate state “From Concentrate” on the fronts of food packages.

Since NCL’s previous complaint to the FDA, the largest producer of tomato sauces, ConAgra Foods, has taken some corrective steps. The company’s Hunt’s brand removed the claim “Packed full of premium vine-ripened tomatoes” from its tomato sauce label, and the words “packed in season” were removed from the company’s Angela Mia Pizza Sauce label. Other misleading claims, however, remain. NCL has written ConAgra saying the company has “taken a step in the right direction” and urged further corrective actions.

Advocates are concerned that consumers are paying premium prices for products that imply they are made from fresh ingredients, but are really remanufactured from concentrate.

Products that NCL believes are still deceptively labeled include:

• Del Monte Seafood Cocktail Sauce that claims “Made from California Vine-ripened Tomatoes” on the front of the package when, in fact, it is made from concentrate (tomato paste and added water). An image of a vine-ripened tomato appears directly below the claim.

• Classico Tomato & Basil Pasta Sauce that states on the label “In colorful Naples, pasta sauces are pure and simple, with ripe, red tomatoes…” when the product is actually made from concentrate. The claim has been deleted from new “value size” 44 oz jars of the sauce, but still appears on the label of the smaller, 24-oz. product.

• Contadina Pizza Sauce and Contadina Puree that state “Contadina picks the Freshest Tomatoes,” and “Our vine-ripened Roma style tomatoes are grown to a rich red color before picking…” (a picture on the front label depicts vine-ripened tomatoes and a tomato field and the term “ROMA STYLE TOMATOES” appears on the front of the package below the Contadina brand name). The products, in fact, are made from concentrate.

Other products with misleading labels identified by NCL are Francesco Rinaldi Original Traditional Pasta Sauce and Gia Russa Tomato Puree.

“Companies making misleading claims should note that ConAgra, the industry leader, has changed some of its labels to ensure that their claims are honest and fair. We hope this sends a signal to other companies that taking corrective action is the smart thing to do given recent increases in regulatory scrutiny by federal and state authorities,” said Greenberg.

 

Think you’re eating fruit? Think again – National Consumers League

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NCL is calling on the feds to investigate a new food ingredient that’s being sold to food manufacturers as a “sweetened dried cranberry” but actually contains more sugar than fruit and is made from cranberry skins – not whole cranberries.

NCL has alerted the Food and Drug Administration (FDA) to misleading labeling on a new food product, Ocean Spray’s “Choice.” Because this product is being sold as a “sweetened dried cranberry” for use in breakfast cereals, cereal bars, baked goods, and trail mixes, it has the potential to result in the mislabeling of many other food products on the market.  

“Sweetened dried cranberries” (SDCs) have become the common or usual name for a popular ingredient in a variety of foods, capitalizing on the healthy image of cranberries and cranberry juice. According to our information, SDCs are the fastest-growing segment of the cranberry market. SDCs traditionally consist of dried cranberries infused with sugar and coated with a small amount of sunflower oil. Facing growing demand for SDCs and a limited supply of fruit, Ocean Spray Cranberries Ingredient Technology Group recently introduced the “Choice” product as a less expensive alternative to SDCs. Ocean Spray represents “Choice” as an SDC that merely adds citric acid for flavor and elderberry juice concentrate for color. Marketing materials tout “Choice” as a low-cost SDC with the same taste, texture, appearance, and health benefits as other SDCs. For example, one Ocean Spray press release states that “Choice contains the health benefits associated with cranberry, with high levels of bacteria-repelling proanthocyanidins and antioxidants, as well as the anti-inflammatory flavonoid quercetin.”  

Laboratory analyses by Krueger Food Laboratories, commissioned by NCL, on November 4, 2009, found that “Choice” is really little more than cranberry skin infused with sugar syrup. The lab report, a copy of which is attached to this letter, describes analytical results for two separate production lots of “Choice” and one lot of Ocean Spray “Craisins,” the latter being Ocean Spray’s standard SDC product. The test results indicate that “Choice” consists mainly of sugar. The analysis found that the soluble solids in “Choice” “consist primarily of inverted beet sugar and citric acid” and are “less than those consistent with the use of whole cranberries.” The organic acids content (except for citric acid), potassium content, and anthocyanin content are significantly lower than those for SDCs. The cranberry content is so small that Ocean Spray must add color in the form of elderberry juice concentrate and acidity in the form of citric acid to simulate the color and acidity of cranberries. These findings are consistent with Ocean Spray claims that they use 50 percent fewer cranberries to make “Choice” than they do for their regular SDC product (See Ocean Spray press release entitled “ITG Provides Customers With Choice,” dated October 8, 2008.)

NCL believes that Ocean Spray’s “Choice” product is misbranded. First, given the small cranberry content and different nutrient profile of “Choice,” we do not believe that “sweetened dried cranberries” is an appropriate common or usual name for this product. Food and Drug Administration (FDA) regulations require that the common or usual name of a food “shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients… and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name.” 21 C.F.R. § 102.5(a). A common or usual name may be established by common usage. 21 C.F.R. § 102.5(d). NCL believes that the term “sweetened dried cranberry” has become established by common usage as the name for a food product consisting mainly of cranberries infused with sugar and dried to a specific moisture content. Ocean Spray’s “Choice” product, because of its minimal cranberry content and use of other ingredients to simulate the flavor and color of cranberries, should not be named “sweetened dried cranberries.” 

We question whether the word “cranberries” should be allowed at all in the name of this product. When an ingredient is highlighted as a characterizing ingredient in a product name, FDA generally requires that the product contain a sufficient amount of that ingredient to characterize the food. For example, “honey bread” and “honey buns” must contain at least 8 percent honey. FDA, Compliance Policy Guides § 505.350. See also FDA Warning Letter CHI- 24-95 (“made with real fruit” claim is false and misleading “for a product made primarily with corn syrup and sucrose… and containing natural and artificial colors”). If the word “cranberries” is allowed to appear in the product name, NCL recommends that “Choice” be required to use a common or usual name that accurately describes the product and makes clear that the product does not contain whole berries (e.g., “sweetened dried cranberry skins with other flavors and colors” or “flavored cranberry skins”).   

Second, we understand that “Choice” labels include an ingredients declaration that lists cranberries as the predominant ingredient. According to our lab analyses, this is false and should be corrected to list sugar as the predominant ingredient. All food labels are required to list ingredients in descending order of predominance by weight. 21 C.F.R. 101.4(a)(1).  

Third, we question the validity of Ocean Spray labeling and advertising claims that “Choice” delivers the same health benefits as “sweetened dried cranberries” and other cranberry products, given the fact that most, if not all, of the cranberry content has been removed from “Choice.” Aside from lower levels of anthocyanins and potassium, our tests found that “Choice” contains only about one-fifth the amount of quinic acid as Ocean Spray’s Craisins. NCL requests that FDA investigate whether the claims of health benefits for “Choice” are false or misleading.  

NCL is also concerned about the many food products that are currently made with “Choice” or will be in the future. Muffins, cereals, and trail mixes should not be able to pass off flavored cranberry skins as if they were sweetened dried cranberries. To avoid misleading consumers, these products should be required to list “Choice” by its appropriate common or usual name in their ingredients declarations, and to declare the component ingredients in “Choice” in their order of predominance. FDA regulations require nothing less.   

NCL urges FDA to make clear to the food industry that it will not accept ersatz foods and ingredients being passed off to consumers as the real thing, especially where the food in question is marketed for its health benefits. We therefore request that FDA investigate Ocean Spray “Choice” and take appropriate enforcement action.