SCHUMER: LONG ISLAND DIETARY SUPPLEMENT COMPANIES THAT RISKED HEALTH OF PUBLIC & GAVE BAD RAP TO IMPORTANT LOCAL INDUSTRY MUST BE PROBED WITH FULL FED AUTHORITY; FDA HAS DONE ITS JOB, NOW HHS MUST DO THEIRS; ONE BAD APPLE SHOULDN’T BE ALLOWED TO SPOIL ENTIRE BUNCH FOR INDUSTRY IMPORTANT TO LI ECONOMY & JOBS
LI Dietary Supplement Owner Was Just Told By The FDA To Destroy All Its Supplements & Drugs By Next Friday For Alleged & Serious Public Health Risks; Schumer Says This Cries Out For A Deeper Fed Probe Given Years Of Failed Inspections
Senator Also Says To Keep Reputation Of Local Industry Strong, FDA Must Weed Out Bad Apples & Recommit To Modernizing & Reforming Its Oversight Of Dietary Supplement Industry Because A Level Playing Field Is Essential
Schumer: Bad LI Pill Practices Could Unfairly Swallow Up A Local Industry Trying Its Best Amid Lack Of Fed Guidance
With the New Year dawning, and the sale of dietary supplements likely to surge, in part because of a variety of health-related resolutions, U.S. Senator Charles Schumer, today, demanded that three Long Island companies with the same owner, just nailed for allegedly distributing adulterated dietary supplements and misbranding a variety of drugs, face a full federal probe by the Department of Health and Human Services (HHS). Schumer said that the three Edgewood companies—now forced to destroy all of their products by next Friday—risked the health of the public by claiming their supplements worked wonders in treating serious conditions like cancer, heart issues, and HIV.
“Bad Long Island pill practices could unfairly swallow up a local industry trying its best amid a lack of federal guidance,” said U.S. Senator Charles Schumer. “When ABH and its subsidiaries made outrageous claims that risked the health of the public they also risked the health of the local economy, because this is an important industry locally, and one bad apple should not be allowed to spoil it for all. This violation of the public’s trust and the Long Island economy cries out for a deeper federal probe given the years—the years—of failed inspections."
Schumer commended the Food and Drug Administration (FDA) for its good work on this local case and for addressing immediate dangers to the national supply chain, BUT Schumer made the case that long-term public health was endangered by these companies—documented for breaking serious rules for years—and said that they must be held responsible to deliver more answers. Schumer also said that the dietary supplement industry on Long Island was unfairly put at risk by this local ‘bad apple’ case and that the FDA must recommit to modernizing and reforming its oversight of this industry. He said companies taking public health seriously lose money, market share and jobs when other companies that disregard public health for the sake of profits are allowed to operate without repercussions. Schumer was joined by local officials from the Department of Health as he made the case for the federal investigation and cited his concerns for local industry.
According to the FDA, ABH and its subsidiaries failed inspections for several years, deviating from Current Good Manufacturing Practice (CGMP) standards enforced by the FDA. Schumer detailed those years of failings:
- November 2018
- February 2018
- November 2016
- August 2013
- May 2013
- July 2012
Specifically, Schumer revealed that during these FDA inspections, including the most recent, the Edgewood facility did not comply with safety standards related to manufacturing, preparation, packing, labeling and distribution of dietary supplements. The company also violated a variety of dietary supplement regulations that related to failed ingredient testing and purity. In other words, the ingredients in the products were not declaratively known. The company also failed with record-keeping, and introduced adulterated supplements into the larger supply chain. Schumer further revealed that the company also claimed that unverified ingredients including olive oil, garlic, Vitamin D, coconut oil, fish oil(s), whey, goat weed extract, and others should be taken—for benefit—by people with heart conditions, inflammation, high blood pressure, cholesterol and even more serious issues like cancer and HIV. According to the FDA, there was not enough adequate evidence to support these false and misleading health claims.
Schumer further said this case jeopardized the local drug and supplement industry on Long Island. Schumer said that in order to keep the reputation of the local industry strong, the FDA must continue to weed out bad apples and recommit to modernizing and reforming its oversight of the dietary supplement industry and ensure a level playing field. Last year, the FDA said, they were concerned that changes in the dietary supplement market may have outpaced the evolution of their own policies and their capacity to manage emerging risks. The agency admitted it needs to modernize and strengthen their overall approach to dietary supplement products and committed to new priorities when it comes to oversight of dietary supplements. The FDA said it would carefully evaluate what more it can do to meet the challenge of effectively overseeing the dietary supplement market. Schumer wants them to keep and advance this promise in 2020, so cases like this do no present themselves.
According to the Long Island Press, the pharmaceutical industry in general is growing on the Island. In 2018, the industry employed about 13,007 people in Nassau and Suffolk counties, up from about 10,000 a decade ago. State figures, also reported by the Long Island Press, say the industry tends to be high paying, having spent about $293 million in wages in 2018, up from about $500,000 in 2003. The industry employs a number of scientists and researchers, whose salaries are in the six-to-seven-figure range.
There are about 25 companies in the industry, the majority of them in Suffolk, according to the report.
“At the end of the day, ABH did a disservice to public health and the economy of Long Island, and that is unacceptable,” Schumer said.