The request was formally submitted to the Senate Finance Committee’s Covid-19 hearing, “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process”, which occurred yesterday (June 2).
Since the start of the Coronavirus pandemic, the FDA has suspended most on-site cGMP (current good manufacturing practice) inspections and is waiving certain FSMA requirements in the face of the COVID-19 crisis. In addition, the Agency announced in March that it would ease requirements around reporting dietary supplement–related adverse events during the pandemic.
Speaking to NutraIngredients-USA, Daniel Fabricant, PhD, NPA’s president and CEO, said the COVID-19 health crisis is not an excuse for the FDA to stop doing its job.
“We have four areas for enforcement, NDIs, claims, GMPs, and AERs,” said Dr Fabricant, “The Agency has taken two of those down because of COVID, so what’s left?”
Fabricant added that the last time the FDA provided dietary supplement import alerts to prevent adulterated ingredients that have not completed the New Dietary Ingredient notification process entering the US was 2014 when he was director of the Division of Dietary Supplement Programs (as it was then) for Kratom.
During Dr Fabricant’s tenure at the Agency, an import alert was also issued for dietary supplement products from firms that have not met dietary supplement GMPs.
In its letter to the Senate Committee, NPA wrote: “Creating an import alert for new dietary ingredients that have failed to comply with the NDIN regulations would provide the Agency with the ability to police the market in a way that is resource-efficient and consistent with the goals of protecting the public’s health, and provide the intellectual property protection the industry desperately needs. This process would restore integrity to the NDIN process, protect intellectual property, and provide the necessary safety net our consumers rely on.”
Ullman: “FDA refuses to use the enforcement devices in its arsenal”
Marc Ullman, Of Counsel for Rivkin Radler, has bemoaned the lack of enforcement around NDIs for almost a decade (for an interview between Ullman and NutraIngredients-USA’s Hank Schultz on this very topic from SupplySide West 2013, please click HERE).
“Something I have complained long and loud about is the refusal of FDA to use any of the enforcement devices in their arsenal to protect companies who do all the right things and file an NDI notification,” Ullman told us this week.
“Dr Fabricant knows exactly what would be involved in issuing an import alert. OK, it’s not 100% of the people trafficking ingredients of unknown quality, but it can cover many of them.
“An import alert is a couple of strokes of the keyboard, but FDA has refused to take action.”
Ullman added that the vast majority of these knock-off ingredients are coming from outside the US. “It’s another example of FDA failing to act despite various serious sounding official statements. NPA’s comments are right on point. This is a serious topic that FDA has refused to address.”
FDA: We regularly use import alerts
In response to questions from NutraIngredients-USA, a spokesperson for the FDA said the Agency regularly issues import alerts, while acknowledging that “the kratom import alert, which was the last import alert issued for a new dietary ingredient, was initially issued in 2014 and is updated as new firms/products are encountered, most recently in 2016.
“The FDA uses the import alert tool every day as part of its import process,” continued the spokesperson. “Resources at FDA headquarters and in the field are utilized as part of the day to day import process to help make admissibility decisions. When the FDA becomes aware of non-compliant products being offered for import, the Agency takes action to deny entry. This action includes detention and refusal and may result in application of detention without physical examination in the form of an import alert to deny entry to future shipments.
“It should be noted that the FDA can and often does take action to deny entry to non-compliant products without the presence of an import alert. Additionally, it is not accurate to say that an import alert “requires no additional resources.” Although import alerts, when appropriate, can be efficient regulatory tools, they require time and resources from multiple agency components to draft, support, review, clear, implement, and operationalize.”
According to the FDA website, an import alert serves four purposes:
- Prevent potentially violative products from being distributed in the United States;
- Free-up agency resources to examine other shipments;
- Provide uniform coverage across the country;
- Place the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with the FDA's laws and regulations.
In addition to import alerts for adulterated ingredients used in dietary supplements, NPA is also calling for expanded participation in the Supplement Safety and Compliance Initiative (SSCI).
“SSCI is an industry-driven initiative led by the nation’s leading retailers to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain,” stated NPA. “SSCI is a bold step forward in providing quality assurance from harvest to retailer shelf. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers, all with the goal of providing quality products and increasing consumer confidence.”