“It’s clear that parts of this industry are operating as if this was the Wild West, where basic standards of honesty and oversight are nonexistent—and they seem to be getting away with it,” said Sen McCaskill. “It’s important to get a sense of what actions the Department of Justice has taken and whether those actions have resulted in meaningful prosecutions.”
In her letter to Attorney General Lynch, which can be read HERE, Sen. McCaskill has requested a list of all cases referred to DOJ related to dietary supplements since 2005 and any subsequent enforcement actions taken by the Department of Justice.
McCaskill on brain health supplements
Sen. McCaskill has become increasingly vocal against the presence of “fraudulent or unsafe dietary supplements” in the marketplace. She opened an inquiry into brain health supplements last summer by sending letters to the FDA and 15 major retailers after launching an inquiry into products, regulations, and retailers in the dietary supplement industry that specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease.
She also called on the FDA to suspend sales of supplements containing vinpocetine and picamilon pending an investigation. When the Agency was perceived to not be acting quickly enough, Sen McCaskill wrote to the 10 retailers to ask them to voluntarily remove any picamilon supplements.
Accounting
Dr Daniel Fabricant, executive director and CEO of the Natural Products Association, told us that the letter is consistent with what Sen. McCaskill done in the past. “She’s trying to get an accounting of the enforcement actions, to see if there are any hotspots,” he said.
Department of Justice action has ramped up in recent years, with GMPs actions the major focus starting in 2011, while Dr Fabricant was director of the Division of Dietary Supplement Programs at the FDA.
US AG Loretta Lynch recently addressed consumers in a video about the department’s work protecting the health and safety of consumers from “unsafe dietary supplements”, so does Sen McCaskill have a friendly ear at the DoJ? “We didn’t read into video as much as others,” said Dr Fabricant. “The video was made during National Consumer Protection Week so she had to put in an effort.”
“We need to get better stats around how the wider picture looks,” added Dr Fabricant. “What is the total case load and how does that compare to other caseloads in other industries?”
Mike Greene, VP of governmental affairs for CRN, told us that the association is more than willing to work with the US Senate Special Committee on Aging if there is a real issue, but it’s starting to look like a fishing expedition.
“Sen McCaskill is clearly interested in dietary supplements and she has concerns,” said Greene. “CRN believes she should request this kind of information but at some point she should recognize that there are more important issues. We have met her and her staff repeatedly to provide resources and educate them about the industry and to help them accomplish their goals, but also to help them know when to move on to more useful goals for the senior citizens who rely on the Special Committee on Aging.”