All Stories Featuring: Dr. Ken Spaeth, Director, Occupational and Environmental Medicine, North Shore University Hospital
August 6, 2013
Senators Pitch Stricter Vetting of Supplements
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August 6, 2013
Bodybuilding Steroids Don't Belong In Vitamin Products
August 5, 2013
Senators Propose Legislation on Supplements
Adverse reactions from supplements and herbal remedies have led two U.S. senators to propose legislation requiring additional information on product labels.
It comes as patients continue to report symptoms linked to tainted vitamins manufactured in Farmingdale.
"Consumers don't know some dietary supplements are unsafe until they're in the hospital, and by that time it's too late," Sen. Richard Blumenthal (D-Conn.) said in a statement.
Blumenthal and Sen. Dick Durbin (D-Ill.) introduced the proposal late last week.
"This legislation would make lifesaving information available to the FDA that may stop suspect products from causing injury, or even death," according to Blumenthal's statement.
Many supplements have purposely added illegal weight-loss chemicals, sexual-enhancement and bodybuilding compounds or other additives, such as excessive caffeine, according to an April article in the Journal of the American Medical Association. Supplements are not required to undergo the tough -- and expensive -- regulatory scrutiny required of prescription drugs.
Blumenthal said the measure would help consumers make educated choices by requiring more information about contents on product labels. The bill would also give more authority to the Food and Drug Administration by requiring manufacturers to register their products and the ingredients.
Manufacturers, he added, would have to provide proof of health-benefit claims.
Called the Dietary Supplement Labeling Act, the legislation comes as federal investigators continue to probe how anabolic steroids found their way into the vitamin products of a Long Island supplement maker.
The FDA isolated two potent steroids, dimethazine and methasterone, from the vitamins produced by Purity First Health Products, Inc. in East Northport.
Dr. Ken Spaeth, of the North Shore-LIJ Health System, the physician who linked the illness of 20 patients to Purity First's vitamin capsules, reported Monday that as many as 10 more patients may have suffered adverse symptoms. Those cases are being evaluated.
To date, 29 people have been sickened after consuming Purity First's vitamins. One person was hospitalized. Anabolic steroids are used by bodybuilders to increase muscle mass.
Candice Tripp, the East Northport owner of Purity First, insists her vitamins were never tainted. The owner of the Farmingdale manufacturing company, Mira Health Products Ltd., which produced Tripp's vitamins, said through a lawyer last week that the firm has hired a professional laboratory consultant to investigate the matter.
Early last week, federal health officials had urged Tripp to voluntarily recall only her vitamin B product. But before the week ended, the government was urging her to include certain lots of her vitamin C and mineral products as well.
There are more major recalls nationwide of dietary supplements than prescription drugs, research shows.
In April, a study reported in the Journal of the American Medical Association found that 51 percent of the FDA's Class 1 recalls involved dietary supplements. A Class 1 recall involves dangerous products that can cause serious health problems or death.
Most supplements in the study contained sexual-enhancement, bodybuilding or weight-loss aids, researchers found.
Currently, the FDA has no authority to require detailed ingredient information from a manufacturer about a dietary supplement before it is put on the market, Durbin said. "Regulation of supplements can be improved to protect public health and it starts with making more information available to consumers and the FDA," he said.
He added that the bill goes beyond previous federal measures by ensuring that a supplement's ingredients are registered with the FDA and that a supplement's risks are printed on the label. He and Blumenthal said they want to make certain that supplement makers can back up their claims.
August 5, 2013
Recent Recall Sheds Light On Lack Of Regulation Of Dietary Supplements
August 3 , 2013
Recall of Purity First Vitamin Supplements Widens
August 2, 2013
Recall of Purity First Vitamins Widens
The recall of vitamins produced by a Long Island company has expanded to include certain lots of the supplement-maker's vitamin C and mineral products.
The U.S. Food and Drug Administration announced late Thursday that most of the vitamins marketed by Purity First Health First Products Inc. also are subject to voluntary recall for containing anabolic steroids.
Owner Candice Tripp, who ran Purity First for years in Farmingdale before recently moving the operation into her East Northport home, said she's cooperating with federal health officials.
Earlier this week, the FDA asked Tripp to voluntarily recall her Healthy Life Chemistry B-50 vitamins in the 100-capsule container from the market.
Now, the voluntary recall has expanded to include her 200-capsule multi-mineral product and the 200-capsule containers of vitamin C.
The U.S. Food and Drug Administration's laboratory isolated two potentially dangerous anabolic steroids in the B-50 vitamins, dimethazine and methasterone.
In addition to causing physiological harm, methasterone is also a Class III controlled substance, which means it carries a moderate risk of physical or psychological dependence.
To date, 29 illnesses have been confirmed, but federal health officials say that number could rise.
All of Tripp's supplements are manufactured at Mira Health Products Ltd. in Farmingdale, and had been recommended to numerous patients by a Farmingdale chiropractor. The vitamins were marketed nationwide via the Internet and in retail outlets.
Neither company knows how the potent steroids got into the vitamins.
Tripp, president of her one-person vitamin firm, said she believes the situation with her product is part of a government ploy to drive small vitamin-makers out of business.
"All of my customers are backing me," Tripp said, noting that she has been in business for more than 20 years and has had no problems.
"I am saying it's not the vitamins. These 29 people had nothing to do with the vitamins. This is environmental," Tripp said.
Mark Ullman, the Garden City lawyer who represents Mira Health Products, said the company has been cooperating with the FDA all along.
"The company is working with the consultant to undertake a thorough review of its procedures," he said.
Dr. Ken Spaeth, director of occupational and environmental medicine at the North Shore-Long Island Jewish Health System, linked the vitamins to the illnesses starting in February, and notified the FDA and local health authorities.
He diagnosed specific anabolic steroid-related symptoms in 20 patients. An additional nine were reported as adverse events to the FDA.
Women patients reported a loss of menstrual periods, hair loss and lowering of their voices — masculinizing symptoms. Men reported a loss of libido and low testosterone. Patients range in age from 12 to 75.
Spaeth said patients didn't want to believe their vitamins triggered their illnesses because they consumed them to bolster their health. "It's time to have a broader discussion about the safety and quality of supplements," Spaeth said Friday.
A study earlier this year found that dietary supplements accounted for more than half of the FDA's major recalls between 2004 and 2012.
The supplements were cited for containing ingredients with a possibility of causing serious health consequences.
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