In a letter to FDA commissioner Robert Califf, Sen McCaskill wrote: “Given the ongoing public safety concerns involved, I urge the FDA to quickly consider this comment and others and finalize its guidance as soon as possible. American consumers cannot afford to wait for another five years.”
The letter, dated December 12, 2016, outlined three areas of the draft guidance that Sen McCaskill said need improvement to ensure that manufacturers understand their responsibilities, and that consumers remain safe, including transparency about the ingredients for consumers and healthcare professionals and the need to take aggressive enforcement actions against any manufacturers making and selling unsafe and illicit supplements.
“This guidance will play a critical role in improving industry compliance with FDA standards and clarifying a process often fraught with confusion and a lack of transparency,” she wrote.
Transparency
McCaskill, the top-ranking Democrat on the Senate Special Committee on Aging, said that increasing transparency is an essential step toward enabling Americans – and their physicians – to make informed decisions about the products they consume.
“I urge FDA to modify its draft guidance to include a provision for the publication of a list of all submitted NDI notifications, including the name of the ingredient, the name of the submitting firm, FDA’s response to the NDI notification, and a link to the notification on the Federal Register,” she wrote.
Sen McCaskill also stated that, while she supports the creation of the grandfathered list of ingredients, for transparency, the agency should make public any information used to establish the list, “as well as specify the form in which grandfathered ingredients appeared prior to 1994.”
Enforcement
FDA has often cited what it sees as a discrepancy in the numbers: There are over 55,000 dietary supplements on the market, and about 5,500 new dietary supplement products come on the market each year, but the agency has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994.
“From 1994 to 2004, FDA sent no warning letters and took no enforcement actions against manufacturers for failing to submit an NDI, and between 2012 and June of 2015 they conducted fewer than 60 enforcement actions, including warning letters,” states Sen McCaskill.
“[T]here is almost nothing in the guidance that outlines the consequences for non-compliance,” she adds. “For this guidance to achieve its desired effect on industry behavior, FDA must make clear it will respond to any failure by manufacturers to submit required NDI notifications with strong enforcement action.”
A copy of McCaskill’s letter to FDA Commissioner Califf is available online HERE.
Don’t rush…
In response to Sen McCaskill’s letter, Dr Dan Fabricant, CEO and executive director of the Natural Products Association, told NutraIngredients-USA: “This is all the more reason why they have to get this right and not rush to finalize the rules. We don’t just need greater clarity from FDA on this issue, we need a full overhaul of the current guidance. The way it stands now, the guidance could actually result in more bad actors skirting the law entirely, which is the opposite of what a sensible regulatory regime should be. NPA’s 98-page comment brief underscores the need for significant changes to the current guidance in the best interest of public health.”
Duffy MacKay, Sr VP of scientific and regulatory affairs at the Council for Responsible Nutrition, told us that his organization agrees that increasing transparency is an essential step to enabling Americans to make informed decisions about the products that they consume.
“Furthermore, we agree that a searchable database of NDI submissions and FDA responses would support this effort.
“CRN appreciates McCaskill’s interest in dietary supplements, but notes that some of her suggestions would result in consuming resources without a clear benefit to protecting public health. For example, the letter requests that FDA make available the evidence used to determine that an ingredient was on the market over 22 years ago. There are many ways that FDA could use its resources to improve transparency, compliance, and public health – but making a database of 22-year old purchase orders and catalogues has questionable value,” said Dr MacKay.