HEALTH

FDA seeks shutdown of James G. Cole for masquerading adulterated drugs as supplements

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice requirements for dietary supplements and all disease claims are removed from its websites, product labels and all other products and websites under Cole’s custody and control.

“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.” 

James G. Cole has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition and Maxam Nutraceutics. 

Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient. 

The complaint was filed in the U.S. District Court for the District of Oregon, Portland Division.

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WebMD launches web-based flu-tracking map

BY Michael Johnsen

NEW YORK — WebMD Health on Monday announced the availability of the WebMD Cold and Flu Symptoms Across the Nation map and companion health center to help consumers stay ahead of cold and flu symptoms this season.  

"We tend to be a bit complacent about cold and flu season until it strikes, which is why preparation is key," stated Michael Smith, WebMD chief medical editor. "The Cold and Flu map and the resources available on WebMD help consumers stay on top of symptom trends in their area, so they can take the necessary steps to help themselves and their families stay well."

WebMD’s Cold and Flu map uses a combination of geo-location data and information compiled from more than 3 million Symptom Checker visits per month to present a real-time analysis of the spread of colds and flu. Now in its second year, the map displays a county-by-county breakdown of flu symptoms, providing consumers with the latest updates on the severity of colds and flu across the country.

WebMD’s Symptom Checker data has a 0.99 correlation with concentration data from the Centers for Disease Control and Prevention Cold and Flu, but is available to consumers weeks in advance through WebMD’s interactive map. The map displays cold and flu activity across the entire country, or users can narrow their search by city, state or ZIP code for a more personalized view.

Featured within WebMD’s Cold, Flu, and Cough Health Center, the Cold and Flu map is paired with WebMD’s health content. Visitors can get the latest news and features on cold and flu prevention, access interactive tools and videos, and review information on common medications used to treat or reduce symptoms. Visitors also can get WebMD’s physician-reviewed cold and flu information, plus WebMD’s interactive Cold and Flu map, via WebMD’s mobile site for personalized, location-based cold and flu symptom activity.

 

 

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NIH to investigate whether vitamin D helps prevent Type 2 diabetes

BY Michael Johnsen

BETHESDA, Md. — Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay Type 2 diabetes in adults who have prediabetes and are at high risk for developing Type 2. Funded by the National Institutes of Health, the study is taking place at about 20 study sites across the United States, the agency announced Monday.

The multiyear Vitamin D and Type 2 Diabetes study will include about 2,500 people. Its goal is to learn if vitamin D — specifically D3 (cholecalciferol) — will prevent or delay Type 2 diabetes in adults ages 30 years or older with prediabetes. People with prediabetes have blood-glucose levels that are higher than normal but not high enough to be called diabetes.

“This study aims to definitively answer the question: Can vitamin D reduce the risk of developing Type 2 diabetes?” stated Myrlene Staten, D2d project officer at the National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH. “Vitamin D use has risen sharply in the United States in the last 15 years, since it has been suggested as a remedy for a variety of conditions, including prevention of Type 2 diabetes. But we need rigorous testing to determine if vitamin D will help prevent diabetes. That’s what D2d will do.”

“Past observational studies have suggested that higher levels of vitamin D may be beneficial in preventing Type 2 diabetes, but until this large, randomized and controlled clinical trial is complete, we won’t know if taking vitamin D supplements lowers the risk of diabetes,” said Anastassios Pittas, the study’s principal investigator at Tufts Medical Center, Boston.

D2d is the first study to directly examine if a daily dose of 4,000 International Units of vitamin D — greater than a typical adult intake of 600 IUs to 800 IUs a day, but within limits deemed appropriate for clinical research by the Institute of Medicine — helps keep people with prediabetes from getting Type 2 diabetes. Based on observations from earlier studies, researchers speculate that vitamin D could reduce the diabetes risk by 25%. The study also will examine if sex, age or race affect the potential of vitamin D to reduce diabetes risk.

Researchers are recruiting volunteers to take part in D2d. Half of the participants will receive vitamin D. The other half will receive a placebo. Participants will have check-ups for the study twice a year, and will receive regular health care through their own healthcare providers.

The study will be double-blinded, so neither participants nor the study’s clinical staff will know who is receiving vitamin D and who is receiving the placebo. The study will continue until enough people have developed Type 2 diabetes to be able to make a scientifically valid comparison between diabetes development in the two groups, likely about four years.

D2d builds on previous NIH-funded studies of methods to delay or prevent Type 2 diabetes, including the Diabetes Prevention Program, which showed that, separately, lifestyle changes to lose a modest amount of weight and the drug metformin are both effective in slowing development of Type 2 diabetes in people with prediabetes.

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