FDA: Tri-Med selling unapproved, adulterated drugs
SILVER SPRING, Md. U.S. Marshals earlier this month seized articles of prescription and over-the-counter drug products from Tri-Med Labs in Somerset, N.J., at the request of the Food and Drug Administration, the agency announced Wednesday. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.
“The FDA is taking this action because Tri-Med has refused to take these unapproved products off the market after it received warning letters and regulatory meetings,” stated Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “This action shows the FDA’s commitment to protecting the public health from the dangers of unapproved or adulterated drug products.”
The FDA has been on the case approaching 13 years — FDA inspections of Tri-Med since 1997 revealed Tri-Med continued to manufacture and distribute unapproved, misbranded and adulterated drugs with significant Good Manufacturing Practices violations.
Hyland’s teething tablets recalled
LOS ANGELES Standard Homeopathic Co., which manufactures homeopathic products under the Hyland’s brand in mass retail, on Saturday recalled its Hyland’s teething tablets “in an abundance of caution due to an FDA investigation of its manufacturing facility,” the company stated.
Adverse events have been reported, but the Food and Drug Administration has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of teething tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s teething tablets have a wide margin of safety that protects consumers from harm.
“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” stated Mark Phillips, president and chief pharmacist of Standard Homeopathic Co. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
After in-depth analysis, a comprehensive review of the company’s adverse event report log and more than 85 years of safe usage, the company is confident that Hyland’s teething tablets are safe for infants and toddlers. Hyland’s teething tablets are manufactured in the United States and are distributed throughout North America.
In addition to the product recall, Standard Homeopathic Co. is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Co. will continue to closely monitor and evaluate the situation and consult with the FDA.
Natural Products Association responds to TV segment regarding black cohosh
WASHINGTON The Natural Products Association on Monday wrote a letter to the producers of a PBS NewsHour report that last week ran a segment critical of the herbal supplement industry.
Specifically, the segment attacked black cohosh supplements, citing research funded by the Alfred P. Sloan Foundation. Researchers David Baker, professor of obstetrics, gynecology and reproductive medicine at SUNY Stony Brook School of Medicine, and Dennis Stevenson, a staff scientist at the New York Botanical Garden, procured 26 random samples of black cohosh from the Internet and random, unnamed retailers across New York City and Long Island, N.Y., and found that 30% — or between seven and eight — of the samples did not contain black cohosh.
The research is part of to the Sloan Foundation’s “Barcode of Life” research grant, which is exploring “the development of DNA bar codes for plants by operating an international research network and by leading the effort for the 100,000 tree species of the world.” Specifically, Stevenson has been mapping a DNA bar code for black cohosh.
PBS correspondent Paul Solman noted that the DNA-bar-coding had been getting some “high-profile press” of late, stating that “a couple of years ago, two high school students used it to uncover the fishy truth about New York sushi.”
“The Natural Products Association urges you to release the product names you tested and all accompanying relevant data on the material, including how it was sampled and the test methodology, to the Food and Drug Administration so that proper action can take place,” the association wrote in its letter addressed to Solman.
Solman opened the PBS segment with, “Though we rarely do consumer stories, at the New York Botanical Garden not long ago, we happened on one we just couldn’t resist: that in one of America’s fastest-growing and least-regulated industries, medicinal herbs, what you see may not be what you get.”
Tagging the dietary supplement industry as “least regulated” isn’t the only inaccuracy within the report; Solmon also identified black cohosh as one of the “fastest-growing” supplements, joining “ginkgo and ginseng as America’s dietary supplement best-sellers.” However, according to recent SymphonyIRI Group data, sales of each of these supplements were on the decline for the 52 weeks ended June 13 across food, drug and mass (minus Walmart) outlets, and none of these supplements cracked the top-three best-sellers within the herbal category — gingko biloba ranked No. 5, black cohosh No. 9 and ginseng No. 10.