Natural Standard Blog

FDA: Fake Cancer Cures Warning

The U.S. Food and Drug Administration (FDA) has sent warning letters to 23 U.S. companies and two foreign individuals marketing a wide range of products that fraudulently claim to prevent and cure cancer. The FDA also warns North American consumers against using or purchasing these products, which include tablets, teas, tonics, black salves and creams, and are sold under various names on the Internet.

The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, cat's claw, an herbal tea called Essiac® and mushroom varieties such as Agaricus Blazei, shitake, maitake and reishi.

Those companies and individuals warned, the complete list of fake cancer 'cure' products and their manufacturers along with a consumer article on health scams can be found by clicking here.

The FDA urges consumers to consult their healthcare providers about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.

Because these products claim to cure, treat, mitigate or prevent disease but have not been shown to be safe and effective for their labeled conditions of use, they are unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act.

The Warning Letters are part of the FDA's ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers.

Parties that fail to properly resolve violations cited in Warning Letters are subject to enforcement action up to and including seizure of illegal products, injunction and possible criminal prosecution.

Consumers and healthcare professionals should notify the FDA of any complaints or problems associated with these products.

Herbal Science International, Inc. Recalls 12 Dietary Herbal Supplements

Herbal Science International, Inc. is recalling 12 dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.

The U.S. Food and Drug Administration (FDA) regards dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart.

Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, the FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands: Wu Yao Shun Qi San, Qing Bi Tang (Nasal Cleanser), Zhong Fong Huo Luo Wan (Stroke Revito Formula), Xiao Qing Long Tang (Little Green Dragon), Ding Chuan Tang, Xiao Xu Ming Tang, Feng Shi Zhi Tong Wan (Joint Relief), Guo Min Bi Yan Wan and Fang Feng Tong Sheng San.

Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage, and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them.

Lastly, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. Human placenta may transmit disease, and dietary supplements that contain it may not be lawfully marketed in the United States.

All of the 12 products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the Internet.

Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund. Consumers with questions may contact the company at 626.333.9998. Consumers who have been taking the products and have experienced adverse reactions should consult their healthcare professional.

Herbal Science International, Inc. apologized for any inconvenience and expressed its concerns for the health of consumers by conducting a voluntary recall action. Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

Hormone Therapy Health Risks

A new study evaluated the health risks and benefits of estrogen and progestin therapy and found an increased risk of fatal and nonfatal illnesses (malignancies).

Researchers from the University of North Carolina, Chapel Hill, reported that the Women's Health Initiative (WHI) trial of estrogen plus progestin was stopped early, after a mean of 5.6 years of follow-up, because the overall health risks of hormone therapy exceeded its benefits.

The study analyzed health outcomes three years (mean 2.4 years of follow-up) after the intervention was stopped.

The intervention phase was a double-blind, placebo-controlled, randomized trial of estrogen plus progestin (conjugated equine estrogens 0.625 milligrams daily plus medroxyprogesterone acetate 2.5 milligrams daily) in 16,608 women aged 50-79 years. The post-intervention phase commenced July 8, 2002 and included 15,730 women.

The primary end points were coronary heart disease and invasive breast cancer. A global index summarizing the balance of risks and benefits included the two primary end points plus stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture and death due to other causes.

The study found that after the intervention, cardiovascular risk was comparable by initial randomized assignments: 1.97 percent (annualized rate) in the hormone therapy group (343 events) and 1.91 percent in the placebo group (323 events).

The researchers observed a greater risk of malignancies in the  estrogen plus progestin group than in the placebo group (1.56 percent vs. 1.26 percent). More breast cancers were diagnosed in women who had been randomly assigned to receive hormone therapy vs. placebo (0.42 percent vs. 0.33 percent) with a modest trend toward a lower hazard ratio during the follow-up after the intervention.

All-cause mortality was somewhat higher in the estrogen plus progestin group than in the placebo group (1.20 percent vs. 1.06 percent).

The global index of risks and benefits was unchanged from randomization through March 31, 2005, indicating that the risks of  estrogen plus progestin therapy exceed the benefits for chronic disease prevention, reported the researchers.

The increased cardiovascular risks in the women assigned to  hormone therapy during the intervention period were not observed after the intervention.

The study authors concluded that a greater risk of fatal and nonfatal malignancies occurred after the intervention in the estrogen plus progestin group and the global risk index was 12 percent higher in women randomly assigned to receive conjugated equine estrogens plus medroxyprogesterone acetate compared with placebo.

Integrative therapies with good scientific evidence in the treatment of menopause include calcium, sage and soy.

Calcium is the nutrient consistently found to be the most important for attaining peak bone mass and preventing osteoporosis. Adequate vitamin D intake is required for optimal calcium absorption. Adequate calcium and vitamin D are deemed essential for the prevention of osteoporosis in general, including postmenopausal osteoporosis. There is a link between lower dietary intake of calcium and symptoms of premenstrual syndrome. Calcium supplementation has been suggested in various clinical trials to decrease overall symptoms associated with PMS, such as depressed mood, water retention and pain.

Sage (Salvia officinalis) may contain compounds with mild estrogenic activity. In theory, estrogenic compounds may decrease the symptoms of menopause. Sage has been tested against menopausal symptoms with promising results.

Soy (Glycine max) products containing isoflavones have been studied for the reduction of menopausal symptoms such as hot flashes. The scientific evidence is mixed in this area, with several human trials suggesting a reduced number of hot flashes and other menopausal symptoms, but more recent research reporting no benefits. Overall, the scientific evidence does suggest benefits, although better quality studies are needed in this area in order to form a firm conclusion.

Integrative therapies with fair negative evidence in the treatment of menopause include boron, evening primrose oil and wild yam.

Boron is a trace mineral found in soil, water and some foods. It has been proposed that boron affects estrogen levels in post-menopausal women. However, preliminary studies have found no changes in menopausal symptoms.

Available studies do not show evening primrose (Oenothera biennis) oil to be helpful with these potential complications of menopause. Small human studies do not report that evening primrose oil is helpful for the symptoms of PMS.

Despite popular belief, no natural progestins, estrogens or other reproductive hormones are found in wild yam. Its active ingredient, diosgenin, is not converted to hormones in the human body. Artificial progesterone has been added to some wild yam products. The belief that there are hormones in wild yam may be due to the historical fact that progesterone, androgens and cortisone were chemically manufactured from Mexican wild yam in the 1960s.  

Airborne® to Pay $23.3 Million for False Advertising

The makers of Airborne®, a multivitamin and herbal supplement whose labels and ads falsely claimed that the product cures and prevents colds, will refund money to consumers who bought the product, as part of a $23.3 million class action settlement, reports the Center for Science in the Public Interest (CSPI). Additionally, the company will pay for ads in several magazines and newspapers with instructions for consumers on how to get refunds.

Airborne® was created by second-grade teacher Victoria Knight McDowell and her screenwriter husband Thomas Rider McDowell; it promised to "boost your immune system to help your body combat germs" and instructed users to "take it at the first sign of a cold symptom or before entering crowded, potentially germ-infested environments."

CSPI reports that the company's slogan "created by a school teacher!" and insistence that the product be stocked with real cold, cough and flu medicines instead of with dietary supplements added to its success.

In February 2006, states the CSPI press release, ABC News revealed on Good Morning America that Airborne's much-touted lone clinical trial was actually conducted without any doctors or scientists, just a "two-man operation started up just to do the Airborne study."

After the plaintiff notified Airborne of his intent to file suit in March 2006, the company stopped mentioning the study and began toning down the overt cold-curing claims in favor of vague "immunity-boosting" language.

In 2007, the Federal Trade Commission (FTC) and a group of state attorneys general began investigating the various "cold-busting" claims that Airborne® has made since its launch in 1999; the investigations are continuing.

Airborne's basic formula contains: vitamins A, C, and E, other nutrients common in multivitamins, the amino acids glutamine and lysine and an "herbal extract proprietary blend." CSPI cautions that Airborne® may provide too much vitamin A since just two pills provide 10,000 IU, the maximum safe level for a day, and the package directs customers to take three per day.

Consumers seeking refunds for purchases of Airborne® can obtain a claim form by writing to the Airborne Class Action Settlement Administrator, PO Box 1897, Faribault, MN 55021-7152, calling 1.888.952.9080 or by visiting www.AirborneHealthSettlement.com.

The class plaintiff was represented by California law firms who asked the nonprofit Center for Science in the Public Interest's litigation project to join as co-counsel in late 2006 for its expertise in nutrition and labeling lawsuits.

Created in 2005, CSPI's litigation unit has successfully negotiated settlements that have resulted in improved food marketing and labeling practices. According to its Web site, CSPI is dedicated to "keep fighting for government policies and corporate practices that promote healthy diets, prevent deceptive marketing practices, and ensure that science is used to promote the public welfare."

Bisphosphonates and Musculoskeletal Pain

The U.S. Food and Drug Administration (FDA) issued an alert highlighting the possibility of severe and sometimes incapacitating bone, joint and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Bisphosphonates are a family of non-hormonal drugs that are used to prevent and treat osteoporosis.

Osteoporosis is a disease of the bones that makes them weak and prone to fractures. In the United States, about eight million women and two million men have osteoporosis. Those older than 50 years of have greatest risk of developing osteoporosis and suffering from related fractures. In this age group, an estimated one in two women and one in six men will suffer an osteoporosis-related fracture at some point in their lives.

The FDA explained that although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment and necessitating the use of pain-relievers.

Pain is the most common reason individuals seek medical care. Pain is often classified as acute (immediate, short-term) or chronic (long-term). About 30-40 million Americans annually do not experience symptom relief with use of over-the-counter pain-relievers, such as acetaminophen (Tylenol®), aspirin and ibuprofen (Advil®). According to the American Medical Association (AMA), 13-15 million Americans suffer from chronic  and severe pain that is not easily managed. The annual cost of chronic pain in the United States, including healthcare expenses, lost income and lost productivity is estimated to be $100 billion.

The alert stated that the severe musculoskeletal pain may occur within days, months or years after starting a bisphosphonates. While some patients have reported complete relief of symptoms after discontinuing bisphosphonates, others have reported slow or incomplete resolution. The FDA cautioned that the risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

The FDA elaborated that this severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, muscular pains and joint pains that sometimes accompanies initial administration of intravenous (injected into a vein) bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of bisphosphonates taken by mouth. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

The FDA advised healthcare professionals to consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

Integrative therapies with good scientific evidence in the prevention and/or treatment of pain include: acupuncture, bromelain, comfrey, guided imagery, hypnotherapy, hypnosis, music therapy, physical therapy and therapeutic touch.

Integrative therapies with strong scientific evidence in the treatment of osteoporosis include calcium and vitamin D. For more information, please visit Natural Standard's Medical Conditions database.

FDA: Cloned Meat and Dairy Safe to Eat

The U.S. Food and Drug Administration (FDA) has declared that meat and milk from clones of cattle, swine and goats, as well as the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals.

However, there continues to be insufficient information for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.

The FDA has issued three documents on animal cloning outlining the agency's regulatory approach: a risk assessment, a risk management plan and guidance for the industry.

The documents were released in draft form in December 2006; since that time, the risk assessment has been updated to include new scientific information that reinforces the food safety conclusions of the drafts, the FDA reports.

The FDA explained that in 2001, U.S. producers agreed to refrain from introducing meat or milk from clones or their progeny into the food supply until the FDA could further evaluate the issue.

The FDA reports that the U.S. Department of Agriculture (USDA) will convene stakeholders to discuss efforts to provide a smooth and orderly market transition, as the industry determines the next steps with respect to the existing voluntary moratorium.

Consumers should be aware that the agency is not requiring labeling or any other additional measures for food from cattle, swine and goat clones or their offspring because the FDA declares that the food derived from these sources is no different than food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.

The FDA reports that the clones would be used for breeding and would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace.

An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA because cloning does not change the gene sequence. Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding, the FDA states.

The FDA is currently working with scientific and professional societies with expertise in animal health and reproduction to develop standards of care for animals involved in the cloning process. Although the agency is not charged with addressing ethical issues related to animal cloning for agricultural purposes, the FDA plans to continue to provide scientific expertise to interested parties working on these issues.

In the guidance for industry, the FDA does not recommend any special measures relating to the use of products from cattle, swine or goat clones as human food or animal feed. The guidance states that food products from the offspring of clones from any species traditionally consumed for food are suitable to enter the food and feed supply.

For more information, please visit www.fda.gov.

 

Apricot Alert

Kadouri International Foods, Inc. is recalling "King Brand Dried Turkish Apricots" due to undeclared sulfites, according to a press release posted by the U.S. Food and Drug Administration (FDA). Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume this product.

The product comes in 12.5 kilogram (28 pound) boxes marked with lot #35-105 on the side and with an expiration date of 15-07-2008 stamped on the side. According to the report, the recalled "King Brand Dried Turkish Apricots" were distributed nationwide in retail stores and through mail orders.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of undeclared sulfites in "King Brand Dried Turkish Apricots" in packages that did not declare sulfites on the label.

The consumption of 10 milligrams of sulfites per serving may elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite-sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the "King Brand Dried Turkish Apricots" revealed that they contained 70 milligrams per serving.

No illnesses involving this product were reported as of December 12, 2007. Consumers who have purchased "King Brand Dried Turkish Apricots" are urged to return it to the place of purchase for a full refund. Consumers with questions can contact the company at 1.718.381.6100.

Apricot generally refers to the fruit of the Prunus armeniaca tree. In manufacturing, apricot seed oil is used in cosmetics or as a vehicle for pharmaceutical preparations. There are no currently available clinical trials for whole apricots. The most commonly used part of the apricot in integrative medicine may be the pit, which is also known as the kernel or seed.

Apricot pit contains amygdalin, a plant compound that contains sugar and produces cyanide. Laetrile™, an alternative cancer drug marketed in Mexico and other countries outside of the United States, is derived from amygdalin. Based on a phase II trial in 1982, the National Cancer Institute concluded that Laetrile™, an acronym for laevorotatory and mandelonitrile, is not an effective chemotherapeutic agent. Nonetheless, many people still travel to international clinics offering this therapy. Multiple cases of cyanide poisoning, including deaths, have been associated with Laetrile™ therapy.

According to computer simulation, amygdalin may be useful for neuropsychometric symptoms in AIDS patients, as well as for symptoms of psoriasis and hyperoxia. Amgydalin (Laterile ®) does not appear to be effective for treating cancer, and there is currently insufficient available evidence about the effectiveness of apricot and its constituents for other uses.

For more information about apricot, please visit Natural Standard’s Foods, Herbs & Supplements database.

FDA: $71,000 of Dietary Supplements Seized

Approximately $71,000 worth of dietary supplements were seized at the request of the U.S. Food and Drug Administration (FDA).

According to a report released by the FDA, U.S. Marshals seized goods from FulLife Natural Options, Inc. of Boca Raton, Florida, which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.

The FDA explained that although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia (low red blood cell count) and hypertension (high blood pressure). These claims are evident in the products' labeling, including promotional literature and FulLife's Internet Web site.

The FDA stated that it takes seriously its responsibility to protect Americans from unapproved drugs. The FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by the FDA.

The complaint, filed by the U.S. Attorney's Office for the Southern District of Florida, charges that the products are in violation of the drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.

Following an investigation of the firm's marketing practices, FDA officials advised FulLife that the claims related to prevention or treatment of diseases made these products subject to regulation as drugs. Despite the FDA's warnings, the firm failed to bring its marketing into compliance with the law. During subsequent inspections, the FDA found that the offending claims were still being made.

The FDA reported that the seizure at FulLife is the second such enforcement action in two months taken by the FDA against dietary supplements being promoted with drug claims to cure or treat diabetes and other diseases or conditions.

FDA: New Rule for Sunscreen Products

The U.S. Food and Drug Administration (FDA) has proposed a new rule for sunscreen products, including a new UVA rating system and sun warning information.

The FDA proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

The FDA reports that because consumers have been able to identify the level of UVB protection for more than 30 years, the new rule is designed to also alert them to the level of UVA protection.

According to the FDA, sunlight is composed of the visible light that humans can see, and ultraviolet (UV) light is composed of the light that humans cannot see. There are two types of UV light – UVA and UVB. UVA light is responsible for tanning, and UVB is responsible for sunburn. Both can damage the skin and increase the risk of skin cancer.

Skin cancer is the abnormal growth of skin cells. It most often develops on skin exposed to the sun, but it can also occur on areas that are not ordinarily exposed to sunlight. Skin cancer is generally divided into two stages, local (where the cancer affects only the skin) and metastatic (where cancer has spread beyond the skin).

Researchers estimate that more than one million new cases of skin cancer will be diagnosed in the United States this year. One out of five Americans will develop some form of skin cancer during their lifetime.

The FDA reports that the proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. Additionally, the FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, the FDA is proposing that such products be required to bear a "no UVA protection" marking on the front label near the SPF value.

Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. The FDA is also amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, the FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. Products that are SPF50 provide more UVB protection than lower SPF values.

Additionally, the proposed rule revises the existing SPF (UVB) testing procedures, allows new combinations of active ingredients and asks for comments on the issue of nanoparticles.

The FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form.

For more information about integrative therapies that may help block ultraviolet rays, please visit Natural Standard’s Herbs & Supplements database. For more information about skin cancer, please visit Natural Standard’s Conditions database.

 

Antioxidant Supplementation may Increase Skin Cancer Risk in Women

Antioxidant may increase the risk of skin cancer in women, but not in men, a new study suggests.

Skin cancer is the abnormal growth of skin cells. It most often develops on skin exposed to the sun, but it can also occur on areas that are not ordinarily exposed to sunlight.

More than one million new cases of skin cancer will be diagnosed in the United States this year. One in five Americans will develop some form of skin cancer during their lifetime.

Researchers from France tested whether supplementation with a combination of antioxidant vitamins and minerals could reduce the risk of skin cancer. It was performed within the framework of the Supplementation in Vitamins and Mineral Antioxidants study, a randomized, double-blinded, placebo-controlled, primary prevention trial that tested the efficacy of nutritional doses of antioxidants in reducing incidence of cancer and ischemic heart disease in the general population.

Researchers randomized French adults (7,876 women and 5,141 men) to take an oral daily capsule of antioxidants (120 milligrams vitamin C, 30 milligrams vitamin E, 6 mg ß-carotene, 100 micrograms selenium and 20 milligrams zinc) or a matching placebo. The median time of follow-up was 7.5 years.

A total of 157 cases of all types of skin cancer were reported, from which 25 were melanomas. Because the effect of antioxidants on skin cancer incidence varied according to gender, men and women were analyzed separately.

The researchers found that in women, the incidence of skin cancer was higher in the antioxidant group. Conversely, in men, incidence did not differ between the two treatment groups. Despite the small number of events, the incidence of melanoma was also higher in the antioxidant group for women. The incidence of nonmelanoma skin cancer did not differ between the antioxidant and placebo groups.

The study authors concluded that antioxidant supplementation affects the incidence of skin cancer differentially in men and women.

For more information about antioxidants, please visit Natural Standard's Herbs & Supplements database. For more information about skin cancer, please visit Natural Standard's Medical Conditions database.

 

USDA: Ground Beef and Canned Meat Recalls

The U.S. Department of Agriculture (USDA) recently announced three important recalls pertaining to ground beef and canned meat.

A Nebraska firm recalled ground beef and buffalo products due to possible E. coli O157:H7 contamination; a Georgia firm expanded its recall of canned meat products that may contain Clostridium botulinum; and a Michigan firm recalled ground beef products to due to possible E. coli O157:H7 contamination.

Custom Pack, Inc. in Hastings, Nebraska is voluntarily recalling approximately 5,920 pounds of ground beef and buffalo products due to possible E. coli O157:H7 contamination, the USDA reports.

To see a list of the products in the recall, please click here.

The ground beef products were produced between June 1 and June 13, 2007 and were distributed to restaurants and institutions in Nebraska. The ground buffalo patties were produced on June 7, 2007 and distributed to restaurants and institutions in Colorado. None of these products were sold through grocery stores.

Consumers and media with questions about the recall may contact company President David B. Dirks at 402.462.2532.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. The very young, seniors and persons with compromised immune systems are the most susceptible to foodborne illness.

Georgia firm Castleberry's Food Company, owned by Bumble Bee Foods, LLC, is voluntarily expanding its July 19, 2007 recall of canned meat products that may contain Clostridium botulinum, reports the USDA.

Information gathered by the U.S. Food and Drug Administration (FDA) and Food Safety and Inspection Service (FSIS) led to the expanded recall; the organizations found that processing malfunction at the establishment have existed longer than initially estimated.

To see a list of the products Castleberry's is recalling, please click here.

The USDA advises consumers with any of these products to throw them away immediately. Cans should be doubled bagged in plastic bags. Consumers with questions about the recall should contact the company's Consumer Hotline at 888.203.8446.

And finally, Abbott's Meat Inc., a Flint, Michigan establishment, is voluntarily recalling approximately 26,669 pounds of ground beef products because they may be contaminated with E. coli O157:H7, according to the USDA.

For a list of products subject to the recall, please click here.

Each box also bears the establishment number "Est. 10215" inside the USDA mark of inspection.

As of July 21, 2007, no reports of illnesses associated with consumption of these products had been received. The ground beef products were produced between July 12 and July 20, 2007 and were distributed to hotels, restaurants and institutions in Michigan.

Consumers with questions about the recall may contact company HACCP Coordinator Pamela Glasco or company President Edward Abbott at 810.232.7128

FDA: Safety of Aspartame

The U.S. Food and Drug Administration (FDA) has reaffirmed its position on the safety of aspartame, following a review of an Italian study that had linked the artificial sweetener to cancer.

The FDA has completed its review concerning the long-term carcinogenicity study of aspartame entitled, "Long-Term Carcinogenicity Bioassays to Evaluate the Potential Biological Effects, in Particular Carcinogenic, of Aspartame Administered in Feed to Sprague-Dawley Rats," conducted by the European Ramazzini Foundation (ERF), located in Bologna, Italy. The FDA reviewed the study data made available to them by ERF and found that it does not support ERF's conclusion that aspartame is a carcinogen.

According to the FDA statement, aspartame was first approved in the United States in 1981 and is one of the most widely used artificial sweeteners. When metabolized by the body, aspartame is broken down into two common amino acids, aspartic acid and phenylalanine, and a third substance, methanol. These three substances are available in similar or greater amounts from eating common foods.

Upon first learning of the ERF study results, the FDA requested the data from ERF to evaluate the findings. On February 28, 2006, the agency received only a portion of the study data requested. In June 2006, the FDA asked ERF to provide the remainder of the study data initially requested and also offered to review pathology slides from the study. ERF did not submit additional data to the FDA and did not agree to the FDA's review of the pathology slides.

The FDA could not conduct a complete and definitive review of the study because ERF did not provide the full study data. Based on the available data, however, the FDA has identified significant shortcomings in the design, conduct, reporting and interpretation of the study. The FDA found that the reliability and interpretation of the study outcome is compromised by these shortcomings and uncontrolled variables, such as the presence of infection in the test animals.

The FDA reports that pathological changes were incidental and appeared spontaneously in the study animals, and none of the histopathological changes reported appear to be related to treatment with aspartame. The FDA believes that additional insight on the study findings could be provided by an internationally-sponsored pathology working group examination of appropriate tissue slides from the study.

The FDA said that considering results from the large number of studies on aspartame's safety, including five previously conducted negative chronic carcinogenicity studies, a recently reported large epidemiology study with negative associations between the use of aspartame and the occurrence of tumors and negative findings from a series of three transgenic mouse assays, the FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food.

FDA: Zelnorm® Unsafe

The U.S. Food and Drug Administration (FDA) requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing Zelnorm® (tegaserod) because patients who take the drug may have an increased risk of developing heart problems. Novartis agreed to voluntarily suspend marketing of the drug in the United States.

According to the FDA press release, Zelnorm® is a prescription medicine that was approved in July 2002 for short-term treatment of irritable bowel syndrome (IBS) in women whose primary symptom is constipation. It was subsequently approved in August 2004 for the treatment of chronic constipation for men and women younger than 65 years old. Zelnorm® is marketed in 55 countries.

The FDA is currently advising patients who are using Zelnorm® to contact their healthcare providers to discuss treatment alternatives. Additionally, patients who are taking Zelnorm® should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.

Throughout February and March 2007, Novartis reported the results of a new analysis of 29 short-term (one to three months) randomized, controlled clinical trials of Zelnorm® to the FDA. The analysis included more than 11,600 patients treated with Zelnorm® and over 7,000 patients treated with placebo. The data showed that the risk of serious heart-related side effects like chest pain, heart attack and stroke with the use of Zelnorm® is higher than with placebo treatment. Thirteen Zelnorm®-treated patients (or 0.1 percent) experience heart problems, compared with only one patient in the placebo group (or 0.01 percent). Based on these results, the FDA concluded that the benefits of this drug no longer outweigh the risks for most patients.

The FDA announced that it will work with Novartis to allow access to Zelnorm® as an investigational drug for patients who have no other treatment options. In such cases, the benefits may outweigh the risks. The FDA is also considering re-introducing Zelnorm® in the future, if a specific patient population can be identified in which the benefits of the drug outweigh the risks. Any such proposal would be the subject of a public advisory committee meeting before an FDA decision.

In another press release, Novartis announced that it is complying with an FDA request to suspend marketing of Zelnorm®. Novartis reported that the side effects occurred primarily in patients who had pre-existing heart disease and/or heart-related risk factors and insisted that there is no demonstrated causal relationship between Zelnorm® and these events.

Still, Novartis recommends that patients who are taking Zelnorm® speak with their healthcare providers about alternative treatment options. Also, patients can return any unused and unexpired Zelnorm® tablets to Novartis for reimbursement of out-of-pocket costs. More information can be obtained by calling the Novartis Customer Interaction Center at 888.NOW.NOVA (888.669.6682).

For information about integrative therapies for  irritable bowel syndrome  or constipation, please visit Natural Standard's  Condition Center database.

FDA Requests Label Change for Sleep Disorder Drugs

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products strengthen their product labeling to include stronger language concerning potential risks. Sedative-hypnotic products include all drugs used to induce and/or maintain sleep.

The potential risks that will soon be included on the drug labels include severe allergic reactions and complex sleep-related behaviors, which may include sleep driving. The FDA defines sleep driving as "driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event."

According to the FDA press release, in December 2006, the FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events: anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken; and complex sleep-related behaviors which may include sleep-driving, making phone calls and preparing and eating food (while asleep).

The FDA has been working with the product manufacturers over the past three months to update labeling, notify healthcare providers and inform consumers of these risks. Along with the labeling revisions, the FDA requested that each product manufacturer send letters to healthcare providers to notify them about the new warnings. Manufacturers began sending these letters on March 14, 2007.

In addition, the FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, the FDA advises that patients who are treated with sleep medications to read the information before taking the product. Patients should also talk to their doctors if they have any questions or concerns. Patients should not discontinue the use of these medications without first consulting their healthcare providers.

Although all sedative-hypnotic products have these risks, the FDA suggests that there may be differences among products in how often they occur. For this reason, the FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products: Ambien/Ambien CR® (Sanofi Aventis), Butisol Sodium® (Medpointe Pharm HLC), Carbrital® (Parke-Davis), Dalmane® (Valeant Pharm), Doral® (Questcor Pharms), Halcion® (Pharmacia & Upjohn), Lunesta® (Sepracor), Placidyl® (Abbott), Prosom® (Abbott), Restoril® (Tyco Healthcare), Rozerem® (Takeda), Seconal® (Lilly) and Sonata® (King Pharmaceuticals).

Natural therapies for sleep disorders with strong or good scientific evidence include melatonin (a naturally occurring hormone), music therapy and valerian (perennial flowering plant). For more information about integrative therapies for sleep disorders, please visit Natural Standard’s Condition Center. 

FDA: Norovirus Outbreak Linked to Oysters

The U.S. Food and Drug Administration (FDA) has issued a statement advising consumers to avoid raw oysters harvested from San Antonio Bay.

The FDA is investigating an outbreak of norovirus-associated illness linked to eating raw oysters harvested from San Antonio Bay, Texas. The FDA advises consumers to avoid eating raw oysters harvested from this area after February 1, 2007, as a result of reports of illnesses in people who attended a Maryland event where these oysters were served.

Symptoms of illness associated with norovirus may include: nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days.

The FDA advises consumers who ate oyster products served in restaurants after February 1, 2007 and experienced symptoms of norovirus to contact their healthcare provider and local health department. Additionally, consumers concerned about oysters purchased during this period should contact their place of purchase to determine if the oysters are from the affected lot of oysters.

The FDA reports that as of March 2, 2007, illnesses were reported by 25 individuals who ate raw oysters over the weekend of February 9, 2007 - February 11, 2007 at a Bull & Oyster Event in Maryland. The Maryland Department of Health & Mental Hygiene's test results from ill patients are positive for norovirus.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on February 24, 2007 and remain closed as of March 2, 2007. Bayview Seafood, a distributor in Seadrift, TX, issued a voluntary recall on February 26, 2007. Another distributor, Rose Bay Oyster Company of Swanquarter, NC, issued a voluntary recall on February 28, 2007. Oysters subject to the recall were mislabeled by the Rose Bay Oyster Company, indicating Galveston Bay as the harvest area; the implicated oysters were actually harvested from San Antonio Bay. Oysters with tags that read: "Gal 1, 2/2/07" are subject to the recall.

The FDA has said that it will continue working with health officials in Maryland to track any additional cases of norovirus illness.

The FDA warns that people with weakened immune systems, including those affected by AIDS, and people with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

The FDA reports that cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. The FDA suggests that it's always best to cook seafood thoroughly to minimize the risk of foodborne illness.

For more information on seafood safety, please visit www.fda.gov.