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“Adulterated supplements are illegal” is the message that dietary supplement associations are underlining.
“Adulterated supplements are illegal” is the message that dietary supplement associations are underlining following a recent “Dateline NBC” investigational report on adulterated supplements and the practice of “dry labbing.”
A “dry lab” is the industry term for a testing laboratory hired to analyze products that provides fabricated results instead of performing actual testing. Such a lab may release a Certificate of Analysis stating that a product has been tested and confirmed as being safe when in reality it has not been tested at all. “Dateline NBC” reporter Chris Hansen went to testing laboratory Atlas Bioscience, which during the undercover investigation failed to detect dangerous ingredients-including arsenic and lead-in a deliberately spiked product sample, yet provided a Certificate of Analysis citing safety-passing results. Hansen also interviewed testing laboratory Chromadex (Irvine, CA) and its cofounder Frank Jaksch, who was interviewed as an authoritative source on responsible laboratory practices. Jaksch and Hansen took care to state that “most companies are responsible.”
Hansen also spoke to Daniel Fabricant, director of FDA’s Division of Dietary Supplements, who said that FDA is concerned about adulterated dietary supplements. Hansen then referred to FDA’s currently limited resources.
Dietary supplement associations the Council for Responsible Nutrition (CRN; Washington, DC) and the Natural Products Association (NPA; Washington, DC) were quoted in the “Dateline” piece.
“’Dateline NBC’ raised some serious issues in its investigative report,” said Steve Mister, president and CEO of CRN. “We are concerned, as any industry would be, when a few companies engaging in fraudulent and criminal activity overshadow the legitimate products sold by responsible companies….However, let’s be clear: By law, every single bottle of dietary supplements should contain what is on the label, and what is on the label should be in the bottle.”
He continued, “We take seriously the allegations raised by this television program of fraudulent laboratory practices and urge the FDA to use its ample legal authority to take legal action against the companies involved in these illegal activities….We call on FDA to take strong enforcement action against both the companies and the testing labs who do not make safety their top priority…”
Mister pointed out that responsible companies will follow GMPs, which by law make manufacturers and distributors ultimately responsible for their products’ safety, ingredient verification, and testing-including testing done by any third-party laboratories they may hire.
NPA president Jeff Wright commented, “We share the concern about the issue of ensuring that products contain what the label claims and are not contaminated. This issue is highlighted, from time to time, in most consumer products industries, including foods, drugs, and toys…Fortunately, consumers are smart enough to understand that a few or occasional lapses in quality assurance should not translate into suspicion of an entire category of products, especially one with a strong history of safety. Otherwise, people may not eat eggs, spinach, tomatoes, or pistachios today.”
NPA highlighted its own TruLabel and GMP certification programs as promoting quality control.
The American Herbal Products Association (AHPA; Silver Spring, MD) provided its own industry comments, saying that “’Dateline NBC’ failed to inform its viewers that the Total Body Formula product [a recalled supplement addressed in the ‘Dateline’ report] was not legal the moment it was put on the market-federal regulations require that all dietary supplement products must meet label claims…”
It added: “AHPA objects to the show’s questioning the safety of all dietary supplements by extrapolating the problems at one analytical lab to an entire responsible industry.” AHPA also pointed out that it maintains a website to inform visitors about issues related to illegal tainted products, www.keepsupplementsclean.org.
“The [‘Dateline’] show failed to recognize the expertise found in hundreds of supplement companies that understand how to properly qualify a third-party testing laboratory,” added Steven Dentali, AHPA’s chief science officer. “Knowledgeable manufacturers know how to choose a lab and to verify results.”