FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

FOR IMMEDIATE RELEASE
June 19, 2008
Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



"Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term "insanitary" to describe such conditions).

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."

The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.

As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.

If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.

http://www.fda.gov/opacom/backgrounders/complain.html
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Raisins Are Really Good For You

From the Wholefood Farmacy:

"Raisins rank among the top antioxidant foods, according to USDA government tests. Early findings suggest that eating plenty of fruits high in antioxidants, such as raisins may help slow the processes associated with aging in both body and brain.

Andrew J. Dannenberg, M.D. a cancer researcher at the Weill Medical College of Cornell University reports that the antioxidant catechin, found in raisins and some other fruits and vegetables, in the diet of mice genetically predisposed to intestinal tumors reduced the number of tumors by at least 70 percent compared to the control group. This type of study adds to the body of evidence which shows that components of fruits and vegetables have the potential to reduce the risk of colorectal cancer, colorectal adenomas and other gastrointestinal tumors.

Carl L. Keen, Ph.D. from the University of California Davis reports that a significant amount of raisins eaten daily for 4 weeks increased the plasma antioxidant capacity. This in turn decreased the level of circulating oxidized low-density lipoprotein (LDL) also known as the “bad cholesterol”. These data clearly show raisins are an important part of 5-a-day diet and that benefits of eating raisins are similar to benefits seen when eating other fruits and vegetables with these plant antioxidants.

Christine D. Wu, M.S., Ph.D. of the University of Illinois at Chicago, College of Dentistry has found that raisins contain compounds including oleanolic acid that inhibit in vitro growth of Streptococcus mutans, the bacteria in the mouth responsible for tooth decay. Oleanic acid and other compounds in raisins also inhibit organisms associated with periodontal disease, including Porphyromonas gingivalis and Fusobacterium nucleatum. Oleanolic acid is most effective in suppressing in vitro plaque formation by Streptococcus mutans. Prevention of plaque building up on the tooth surface is critical both for preventing tooth decay and promoting healthy gums.

Mary Ellen Camire, Ph.D. of the University of Maine reports that dietary fiber and other components may reduce the risk of heart disease and cancer by binding bile acids and causing their elimination from the body. Camire’s study confirms that eating fibrous foods, such as raisins, stimulates the body to replace the bile acids that have been eliminated by making them from its own cholesterol, thus potentially lowering serum cholesterol and the risk of coronary heart disease. Furthermore, bile acids that are bound by fibers such as those in raisins will not be metabolized to a more toxic form and this may potentially reduce cancer risk.

Gene A. Spiller, Ph.D. of the Sphera Foundation and Health Research Studies Center - Los Altos, CA reports feeding of raisins along with peanuts to 10-12 year old children prior to a soccer game resulted in lower increases in blood glucose and insulin than a snack of a white bagel and jam. This is important because it means a more steady fuel supply to the exercising muscle of the young players. Lower insulin levels are advantageous because high levels of circulating insulin can promote the laying down of fat and may lead to insulin resistance, a concern among US children today, where rates of obesity and type 2 Diabetes are increasing.

You, your family and your children can enjoy all of the health benefits that raisins have to offer with your favorite Wholefood Farmacy foods such as Phi Plus, Apple Cinnamon Phi, Cranberry Phi, Coco Cherry Phi, Fruitalicious, Fruitalicious Plus and Cornaborealis. Enjoy!"

FDA Announces Limited Return of Heartworm Drug to U.S. Market

FDA News
FOR IMMEDIATE RELEASEJune 5, 2008
Media Inquiries: Kimberly Rawlings and Mike Herndon, 301-827-6242Consumer Inquiries: 888-INFO-FDA


"The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.
ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.
"This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs," said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. "While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions."
Heartworm disease is a serious and potentially fatal condition for dogs. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.
The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product.
The return of ProHeart 6 to the market is based on results of additional toxicological and pharmacologic studies by Fort Dodge Animal Health coupled with the low adverse reaction frequency in international markets.
In 2004, Fort Dodge Animal Health agreed to voluntarily recall the product from the market based upon FDA's concerns regarding reports of serious adverse reactions in dogs following the use of ProHeart 6. In response to FDA's concerns, the manufacturer conducted additional testing of its product, which indicated that residues of the solvents used in the manufacture of ProHeart 6 may cause allergic reactions.
The manufacturer has improved the manufacturing specifications for ProHeart 6 to decrease the presence of those residues and has marketed the product in international markets. Few adverse events have been reported with this reformulated product.
The ProHeart 6 label and Client Information Sheet have been revised to include updated safety information. The new label includes warnings not to administer the drug within one month of vaccinations, and to use the product with caution in dogs with pre-existing allergic diseases including food allergies, allergic hypersensitivity, and flea allergy dermatitis. The label also warns against administering the drug to dogs who are sick, debilitated, underweight, or who have a history of weight loss. In addition, the label’s Post-Approval Experience section has been updated to include information about adverse reactions based on voluntary post-approval drug experience reporting.
Dog owners who suspect their dog is experiencing an adverse reaction to ProHeart 6 should immediately contact their veterinarian to initiate appropriate veterinary care. Veterinarians should contact Fort Dodge Animal Health to report any adverse events at (800) 533-8536."
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Additional Information

Cranberry, Awesome Health Benefits

"Imagine a little red berry that fights cancer, age-related diseases like loss of memory, heart disease, ulcers, and even cavities. Sound to good to be true? Allow us to introduce our friend, the Cranberry!

In 1996 laboratory studies conducted by University of Illinois scientists and published in Planta Medica demonstrated the potential anti-cancer properties of cranberries. More recently researchers at the University of Western Ontario demonstrated, in animal models, that human breast cancer cells showed significantly lower incidence of tumor development when the experimental group's diet was supplemented with cranberries.

USDA scientists at the Human Nutrition Research Center on Aging at Tufts University have been finding promising results associated with diets high in antioxidants and other phytonutrients. Preliminary studies suggest that diets containing fruits and vegetables with high ORAC values may provide protection against chronic age-related afflictions like loss of coordination and loss of memory. ORAC stands for Oxygen Radical Absorption Capacity which is a measure of the antioxidant activity for a particular food. Cranberries score very high on the ORAC scale at 1750 ORAC units per 3.5 oz. serving.

A study published in the Journal of the American Dental Association reported that a unique cranberry juice component, a high-molecular-weight nondialysable material (NDM), has the ability to reverse and inhibit the coaggregation of certain oral bacteria responsible for dental plaque and periodontal disease in vitro.

Critical Reviews in Food Science and Nutrition reported on a preliminary clinical trial using a mouthwash containing cranberry NDM. Saliva samples of the experimental group showed a two order of magnitude reduction in Streptococcus Mutans compared with the placebo group. This is exciting news because a large percentage of cavities can be attributed to Streptococcus Mutans.
Flavonoids have been shown to function as potent antioxidants both in vitro and in vivo and may reduce the risk of atherosclerosis (clogged arteries). Cranberries contain significant amounts of flavonoids and polyphenolic compounds that have been demonstrated to inhibit LDL (bad cholesterol) oxidation. Ongoing research continues to suggest that cranberries may offer a natural defense against atherosclerosis. Peptic ulcers are increasingly being attributed to infection by Helicobacter pylori bacteria, as pposed to stress and/or stomach acidity. A high-molecular-weight nondialysable constituent of cranberry juice has been shown to inhibit the adhesion of H. pylori to human gastric mucus in vitro. These preliminary results suggest that cranberry may be beneficial in the prevention of peptic ulcers through the inhibition of H. pylori adhesion to gastric mucus and stomach tissue.

You can find cranberries in Wholefood Farmacy foods such as, Organic Cranberry Phi, Organic Phi Plus, Cranberry Crunch, Fruitalicious, and Fruitalicious Plus – enjoy!"