July 2, 2014
Vitamin makers halt production in settlement with FDA
Featuring: Dr. Kenneth Spaeth, Director, Occupational and environmental Medicine, North Shore-LIJ Health System
At least 29 people were sickened and one hospitalized in what has grown into a nationwide federal alert involving vitamin tablets laced with potentially dangerous anabolic steroids. (Credit: News12)
A father and son who owned a Farmingdale vitamin manufacturing company have agreed to cease all operations in the wake of a long-running federal investigation involving adulterated vitamins produced at their facility.
Michael S. Ragno Sr. and Michael S. Ragno Jr. were cited last year by the U.S. Food and Drug Administration for producing vitamins tainted with anabolic steroids at their Mira Health Products Ltd. plant.
The FDA investigation provided enough evidence for the Justice Department to file a lawsuit against Mira and its owners earlier this year.
In addition to the lawsuit, a consent decree was issued and signed last month by the father and son, acknowledging they sold adulterated dietary supplements and misbranded products containing steroids.
The decree, which stipulated they refrain from re-entering the supplement business unless approved by the FDA, was issued by the U.S. District Court, Eastern Division. Neither father nor son was available for comment Wednesday.
Marc Ullman, the Garden City lawyer who represented Mira last year during the FDA investigation, declined to answer questions about the company and its owners.
But as chairman of the legal advisory council for the Natural Products Foundation, an industry trade organization, Ullman said he's always pleased to see the government take action against adulterated products.
"On the broader-based
question about the sale of adulterated products by anybody, I think serious enforcement action beyond warning letters is long overdue," said Ullman, a critic of the FDA, which he said should write fewer warning letters and force more rogue supplement makers into court.
Mira, located in a rundown section of Farmingdale on East Carmans Road, had a long history of violations, which included not verifying whether its finished products met identity, purity, strength and composition specifications.
The company served as the contract lab for a range of distributors selling dietary supplements, such as Purity First Health Ltd. Purity, operated at different times out of a small Farmingdale building, a Deer Park car repair shop, and, finally, the owner's East Northport house, went out of business last summer.
Owner Candice Tripp had maintained that vitamins she sold were free of contaminants and that she was the subject of an unwarranted probe. Her phone was out of order yesterday.
The Justice Department announced the decree involving the Ragno family and Mira on Tuesday. Tripp was not named in the federal lawsuit.
More than two dozen people became ill after taking Purity's B-50 product and other vitamins. The FDA issued a recall for B-50 and several other company products.
The illnesses, which ranged from fatigue, hair loss, and highly escalated cholesterol levels, had persisted for weeks as a medical mystery. Men who had taken the vitamins experienced breast growth; women's menstrual cycles ceased.
The conundrum was solved by Dr. Kenneth Spaeth of North Shore University Hospital in Manhasset, who traced the problems to Purity's vitamins.
Tests by the state Department of Health and the FDA confirmed the steroid content.
"I think a situation like this is a reminder to us all that we have a long way to go in terms of a regulatory standpoint until we [as consumers] are assured that what we think we are in buying is, in fact, what is in the bottle," Spaeth said. The action against Mira comes within days of another crackdown against a supplement maker who sold tainted products.
Nikki Haskell, owner and chief executive of Balanced Health Products, was fined $60,000 by a U.S. magistrate judge in Manhattan federal court.
She was accused of distributing dietary supplements that contained a dangerous prescription drug.