Over the course of the following weeks and months, we will be sharing news that are directly linked to the Covid-19 pandemic and impacting the regulatory affairs markets such as dietary supplements, medical devices, cosmetics, and more.
While FDA has relaxed requirements for mandatory onsite audit requirements during the pandemic, it is still required to have the appropriate supplier verification in place. RNI recommends that documentation of the appropriate methods (e.g. sampling, testing, or historical food safety records) be maintained.
Particularly in the current environment, it is very important to be diligent in marketing, product claims and social media. RNI recommends extra caution be taken even with generic immune support claims. Terms and phrases associated with the COVID-19 pandemic should not be used, for example, refrain from using variations of COVID-19, coronavirus, virus, viral immune response, pandemic, etc. FDA is tracking labels, websites, and social media and care must be taken with all statements made for products.
In Mid-March, the FDA issued a temporary policy for the Food Safety Modernization Act (FSMA) Onsite audit requirements.
During normal operating procedures, receiving facilities and importers are required to conduct supplier verification activities. Based on the hazard analysis conducted as part of their written Food Safety Plan, such facilities sometimes determine onsite audits to be the most appropriate supplier verification activity. This has been determined by three of the regulations created to implement FSMA: the Preventive Controls for Human Food rule, Preventive Controls for Animal Food rule, and Foreign Supplier Verification Programs rule (FSVP).
Because of the COVID-19 pandemic, however, the FDA took the unprecedented action to step back from mandatory supplier verification onsite audit requirements. Because of worldwide and regional travel restrictions and stay-at-home policies, the temporary FDA policy states: “that the agency will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead.”
The FDA designated alternatives to onsite audits include: sampling, testing, or historical food safety records review to give assurance over hazards during this period of time. The agency intends to inform all receiving facilities of a “back to normal” activity with a sufficient amount of time for all actors to be prepared.
Over the last month, actors in the health industry are trying to help consumers as much as they can in fighting the coronavirus pandemic. This is especially true for dietary supplements, where the demand for immune system products is increasing. Even though the wide majority of dietary supplement companies are playing by the rules, some firms try to boost sales through unlawful marketing actions.
The FDA has taken specific actions, resulting in an acceleration in terms of warning letters issued. Beginning in March, the agency created a specific task force whose role is to monitor “unapproved and misbranded products related to Coronavirus Disease 2019 (COVID-19)”. As such, a new warning letters category has been created, specifically focused on COVID-19. Since March 6th of this year, 57 warning letters have been issued by the FDA, 15 of them (26%) have been issued for a warning related to COVID-19.
The FDA took further steps. Products that have been identified as unapproved products related to COVID-19 as flagged as fraudulent products, and appear on a specific FDA webpage called “Fraudulent Coronavirus Disease 2019 (COVID-19) Products: The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19). We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers.” The FDA even created a dedicated email address (COVID-19-Task-Force-CDER@fda.hhs.gov) for companies to respond to FDA with specific steps that have been taken to correct the violations within 48 hours of the warning notice.
One of the latest warning letters, issued on March 31st, targeted a CBD product as fraudulent for the treatment or prevention of COVID-19. The following claims were made on the company’s website: “Crush Corona… While scientists around the world are working 24/7 to develop a COVID-19 vaccine, it will take many more months of testing before it’s approved and available. However, there’s something you can do right now to strengthen your immune system. Take CBD… CBD can help keep your immune system at the stop of its game… We want everyone to take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection. So, we’re making all of our products more affordable.”