The Natural Products Association formally outlined its request in official comments submitted for a June 2 Senate Finance Committee hearing.
The Natural Products Association (NPA; Washington, DC) is escalating its mission to get FDA to issue an import alert in order to prevent adulterated dietary supplement ingredients from entering the United States. The association formally outlined its request for FDA to issue an import alert in official comments submitted today for a Senate Finance Committee hearing happening on Tuesday, June 2, regarding foreign drug manufacturing inspections.
There are growing concerns that the number of adulterated dietary supplement ingredients entering the U.S. could increase especially during the COVID-19 pandemic, during which time FDA has relaxed several of its oversight mechanisms for dietary supplements, says NPA. As Nutritional Outlookreported in March, due to the pandemic, FDA has ceased performing routine inspections of foreign and domestic dietary supplement and food manufacturing facilities. Due to COVID-19-related staff shortages, in March FDA also loosened deadlines for reporting dietary supplement–related adverse events.
In previous interviews with Nutritional Outlook, NPA and some other members of the dietary supplement industry expressed concern that a scale-back of regulatory oversight, coupled with an increased risk of global economic ingredient adulteration caused by COVID-19-related economic recessions, means that there is a high likelihood that more adulterated, unsafe dietary supplement ingredients will enter the U.S. supplements market and put U.S. consumers at risk of unsafe products.
According to NPA, issuing an import alert will increase scrutiny of incoming ingredients. Daniel Fabricant, PhD, NPA’s CEO and president, explained in his comments to the Senate Finance Committee that many ingredients entering the U.S. are likely new dietary ingredients that, per federal law, require companies to submit to FDA a New Dietary Ingredient (NDI) notification concluding that the ingredient is “reasonably expected to be safe under the conditions of use recommended or suggested.”
Issuing an import alert means FDA could alert U.S. customs officials to deny U.S. entry to any ingredients without an NDI notification legally required. Fabricant says that the last time FDA issued an import alert was back in 2014 for kratom imports.
Import alerts are a “resource efficient” way of cracking down on adulterated imports, without significantly burdening FDA during the pandemic, because the import alerts “[place] responsibility back on the importer to ensure that products being imported to the United States are in compliance with the FDA’s laws and regulations…” Fabricant wrote to the Senate. Import alerts also protect legitimate dietary supplement companies that have legally filed NDI notifications, and many of which hold patents on their ingredients, by preventing copycat companies from disseminating counterfeit ingredients without safety profiles.
“Since the FDA is prioritizing resources and only performing ‘for-cause inspections’ during the COVID-19 crisis, issuing an import alert for products that are adulterated would require no additional resources and would be an effective measure that would provide important information to the Agency to facilitate their enforcement of current dietary supplement regulations,” Fabricant told the Senate.
He said: “Adulterated ingredients that have not completed the New Dietary Ingredient notification process are entering our country at an alarming rate, and it’s been roughly six years since the FDA provided dietary supplement import alerts to prevent this. This puts American consumers and compliant U.S. supplement makers at a terrible disadvantage.”
Fabricant tells Nutritional Outlook that stopping adulterated ingredients at the border gives FDA the opportunity at the start to prevent those ingredients from further infiltrating and being distributed in the larger dietary supplement supply chain once they enter the U.S.
“So often, FDA has to play whack-a-mole,” Fabricant says. “They get the person downstream.” Once an adulterated ingredient enters the country, “They’re selling that adulterated ingredient to how many hundreds of other manufacturers? And you have a chance to root it out at that level, and they’re not going to do that? It’s kind of crazy when you think about it.”
Failing to issue an import alert implies to bad actors that regulatory oversight in the U.S. is lax, Fabricant says. “If you’re not going to enforce the laws you have on the books”-the NDI notification requirement-“you’re signaling to folks who aren’t interested in public health or safety” that they can skirt the law.
“It’s kind of the old broken-windows theory of policing,” he says. “Whereas if you go to neighborhoods with broken windows, burglars come back. Why? Because they know if people aren’t even going to patch up broken windows, it’s going to be a lot easier to commit crimes versus a place where the windows are patched up.”
Will FDA Get the Message?
Fabricant’s comments were submitted on the record for the June 2 Senate Finance Committee Hearing on “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process” to discuss FDA’s actions related to foreign drugs.
Will NPA’s message about dietary supplements be heard within the drug topic setting? Says Fabricant to Nutritional Outlook: “We’re going to submit our questions, and hopefully some members of Senate will ask them. You can also submit questions for the record afterward, and we’ve worked with some Congressional offices to submit those after. So, we’re going to get it some attention. We think it needs some attention because the agency has a big mandate. On the COVID stuff, on the drug side of the house, they’ve been doing great. They’ve had the whole acceleration program looking into therapies for coronavirus; that’s fantastic. But on the food side…why is it that there’s such a disinterest in taking these sorts of actions? So that’s what we want to shine a light on.”