The retailers have been asked about their policies relating to the sale and/or marketing of dietary supplements, and what they had done to prevent sales of harmful or fraudulently marketed products in their stores and on their websites and shows. The 15 retailers are Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo.
“People looking online for cures or treatment for Alzheimer’s Disease and dementia are at their most desperate—and it’s clear from what we’ve found that many of these products prey on that desperation,” said Sen. McCaskill. “Right now it’s like the wild west when it comes to the production, marketing, distribution, and sale of these products. I want to figure out why that is and what we can do to better protect America’s seniors.”
Letters to retailers are available HERE. The retailers have been requested to respond no later than July 13, 2015.
A spokesperson for the the Vitamin Shoppe confirmed to NutraIngredients-USA that they had received a letter from Senator McCaskill’s office and the company intends to cooperate with the committee as appropriate.
FDA enforcement
In a letter to FDA Commissioner Stephen Ostroff, Senators McCaskill and Susan Collins (R-ME) ask the Agency about its obligation to prevent fraud and review new supplement ingredients. The letter also asks what enforcement actions FDA has taken against dietary supplement manufacturers and distributors that fail to comply with FDA regulations and for a detailed description of FDA’s process for evaluating medical and nutritional claims made by supplements already on the market.
“While we understand that the FDA undertakes periodic reviews and targeted investigations of dietary supplements currently on the market, concerns have been raised that the FDA’s current regulatory authorities lack a systemic approach to preventing adulterated, mislabeled, and fraudulent products from entering the market,” write Collins and McCaskill in their letter to the FDA.
“Additionally, we are concerned that the FDA may not be effectively using its existing regulatory authority to adequately enforce the pre-market notification requirements for supplements containing new dietary ingredients. The new dietary ingredient process represents one of the FDA’s only opportunities to perform a pre-market review of dietary supplements to ensure reasonable expectations of safety, yet questions have been raised about how the FDA is utilizing this authority.”
A copy of the letter to the FDA is available HERE. As with the retailers, the FDA has been requested to respond no later than July 13, 2015.
‘Brain Armor’
One of the supplements called Brain Armor was available from Amazon, but the online retailer pulled it from its website after McCaskill alerted the FDA to claims it made about ‘protecting against Alzheimer’s, Dementia, (and) Stroke…’. While that product is no longer sold on Amazon.com, similar products remain on Amazon’s website and the websites of several other national retailers, said the Senator’s office.
“While I appreciate Amazon’s efforts to work with the FDA to remove from the site this dietary supplement that made claims about prevision or treatment of a disease – a practice prohibited by law – I am concerned about how the product came to be sold,” wrote Sen McCaskill in her letter to Amazon.
‘Reaching to the four corners of supplements’
In response to the announcement, Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA) called the letters “interesting”.
“Regarding the Alzheimer’s claims, I think the industry is very supportive of action against marketers making these kinds of claims,” he told us. “She’s reaching to the four corners of supplements on this because companies selling products making Alzheimer’s claims are rarely if ever members of trade associations.”
Dr Fabricant also found it interesting that FTC was not included, and that the letters were sent from the Special Committee on Aging, which cannot write legislation. Senator McCaskill also sits on the Committee on Commerce, Science & Transportation, but the letters came from Aging.
“In the letter to FDA Senator McCaskill is asking about the NDI draft guidance, she is asking about enforcement actions. These are good questions, but what’s the genesis of all this and what is the ultimate goal from this?” asked Dr Fabricant.
CRN: 'This issue has to be addressed'
Talking to NutraIngredients-USA from Capitol Hill, Mike Greene, VP, government relations for the Council for Responsible Nutrition (CRN), explained that there is history with this senate committee and dietary supplements, dating back to at least 2001.
“CRN believes that marketing products to senior citizens that are misbranded or adulterated or making egregious claims is unacceptable and FDA should bring the full force of the law against them. This issue has to be addressed.”
Greene stressed that the current investigation is still young, and asked where it would lead.
“The letter from Collins and McCaskill to the FDA contains a lot of questions. I will be very interested to see how FDA responds to that and how long it takes them to respond.”