RADM Richardae Araojo is joined by CAPT Jason Humbert and Minerva Rogers from the Health Fraud Branch in the Office of Regulatory Affairs at FDA to discuss FDA's efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19.

Health Equity Forum: Episode 2 – Transcript

RADM Richardae Araojo: Hello and welcome to the Health Equity Forum Podcast, hosted by the FDA Office of Minority Health & Health Equity. I'm your host RADM Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA. In this episode, we will be learning about FDA's efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19.

Health fraud includes the sale or distribution of products with false or misleading claims stating that the product is effective against medical conditions, when those products have not been proven to be safe and effective for those purposes. I'm joined today by two of my colleagues from the Health Fraud Branch in the Office of Regulatory Affairs at FDA. Captain Jason Humbert, Director of the Health Fraud Branch, and Ms. Minerva Rogers, Consumer Safety Officer with the Health Fraud Branch.

They're going to tell us more about the actions the FDA is taking against unscrupulous companies that seek to profit from consumer spheres by offering fraudulent products for sale and what can be done to protect themselves and their families from falling victim to a health scam. Captain Humbert and Ms. Rogers, thank you so much for being with us today. Welcome.

CAPT Jason Humbert: Thank you, ma'am. Thanks for having us.

Minerva Rogers: Thank you so much for having us. It's my pleasure to be here.

RADM Richardae Araojo: So to kick us off, CAPT Humbert, can you tell us about your office and the work that you and your team do?

CAPT Jason Humbert: Yes, ma'am. Our group conducts investigations into products sold to consumers with unproven claims or products that may contain undeclared and harmful ingredients. Most of our work involves internet investigations and covers nearly all the commodities that FDA regulates, such as medications, dietary supplements, medical devices, and vaccines. We also monitor a reporting system where consumers can submit reports about products that they see online that may be illegal.

And many of these products are found on websites and social media platforms, sometimes in popular marketplaces. Our goal when we find these products is to take swift action to remove it from the marketplace. And we do this in a variety of ways, such as gathering evidence and working with the product centers at FDA to support an agency action like a warning letter or perhaps an enforcement action like a seizure and injunction.

Briefly, a seizure as a court action where the government asked the court to take custody of illegal products and to order those products to be destroyed or brought into compliance with the law. An injunction is a court action where the government seeks a court order joining the company or an individual from operating unless and until it complies with the law. We work with our field laboratories to identify fraudulent products with hidden ingredients that may pose health risks to unsuspecting consumers.

We're working with the field and import offices to conduct investigations, inspections, and to pursue voluntary recalls of harmful products. And when necessary, we work with our Office of Criminal Investigations, known as OCI, to support criminal enforcement against non-compliant firms.

RADM Richardae Araojo: Ms. Rogers, how does FDA identify whether a product is fraudulent?

Minerva Rogers: There are a couple of quick clues I like to share with our listeners. Number one, be wary of unapproved product that are sold as cure for a disease or medical condition. Another clue is where a product claims to treat or cure a wide variety of serious diseases. For example, if a product says it can cure diabetes and high blood pressure, that is a red flag. Sometimes the centers themselves give us clues.

For example, if they attempt to hide their identity, or if we find that information about the seller to be inaccurate or blatantly false, that is usually a sign that consumers should avoid buying these products.

RADM Richardae Araojo: And what are some common types of health fraud?

Minerva Rogers: We frequently encounter quick fix, cure all products. These go all the way back to the days of Batten medicines in the 19th century. Some of the same schemes are still prevalent today with a quicker and wider reach due to the internet and global e-commerce. We continue to see a wide range of products sold for indications like weight loss and sexual performance, pain management and sleep aids that contain undisclosed ingredients which can be harmful, especially if mixed with prescription drugs.

RADM Richardae Araojo: CAPT Humbert, are most of the products manufactured overseas, or are they created here in the United States?

CAPT Jason Humbert: Well, ma'am, health fraud knows no borders, so products sold with false or misleading claims can originate anywhere. We see plenty of sellers in the U.S., but more recently during the COVID-19 pandemic, we've encountered illegal products from sellers in India, Israel, China, in Ireland, for example. And I think what's concerning is that the sellers often target specific populations in their native language to make the product seem more familiar or more enticing.

And sellers may also include stories or testimonials about how the product worked for individuals in their homeland. And these can be very convincing, so be careful there. We've seen products claim that they're approved or made in the U.S. when they're not or even approved by other regulatory agencies. Listeners should know that the agency works closely with its global partners on a routine basis, and that we're very active at the border consistently examining imported products to try to ensure that unsafe and unproven medical products don't reach U.S. consumers.

RADM Richardae Araojo: Ms. Rogers, which groups do companies target the most?

Minerva Rogers: Unfortunately, health fraud scams can target just about anybody. In the current pandemic, we're all at risk for COVID-19 infection. Certainly we've seen sellers that target higher risk groups like people over 60 years old or those with underlying health conditions like heart disease or diabetes. We've also seen fraudster post messages tailored to specific ethnic populations and in areas hardest hit by the coronavirus. For example, we've seen them using Spanish newspapers and posting to social media accounts in multiple languages.

RADM Richardae Araojo: CAPT Humbert, we're in the midst of a global pandemic. Is your office seeing an increase in fraudulent products claiming to cure coronavirus? And can you give us some examples?

CAPT Jason Humbert: Yes, ma'am. In February, we put together a cross agency task force to gather and share information about fraudulent COVID-19 products. We've received thousands of reports of illicit products, ranging from bogus treatments or cures to inappropriately marketed test kits and fake or substandard personal protective equipment. We've issued warning letters citing products such as essential oils, tinctures, teas, and herbal products. And some of the ingredients are incredibly popular, like colloidal silver.

They come in many forms like capsules or liquids to be ingested, but we're seeing nasal sprays and products to be applied to the skin. And one of those liquids to be ingested, Miracle Mineral Solution or MMS, was marketed as a cure for COVID-19, but it has not been approved by the FDA for any use. When the solution is mixed as directed, it actually forms industrial bleach, which could cause serious and potentially life threatening side effects.

FDA acted against Genesis II Church of Health and Healing for illegally distributing MMS for the treatment of COVID-19 and for other diseases, and we'll continue to take action as companies seek to capitalize on the fear and uncertainty of this pandemic.

RADM Richardae Araojo: What is your office doing to protect consumers?

CAPT Jason Humbert: Our goal is to act quickly to disrupt sales of these products. And we have a few different ways we can do this. In March, FDA launched Operation Quack Hack as a response to the volume of unproven products that inundated the marketplace in the early days of the pandemic. We're working closely with the Federal Trade Commission to issue warning letters, as I mentioned earlier, and these warning letters requests that the recipients take voluntary corrective action within 48 hours, which is a much shorter timeframe than other warning letters.

We've also alerted various platforms or marketplaces about unapproved, unauthorized, or uncleared COVID-19 medical products. These initiatives have led online marketplaces to remove hundreds of fraudulent COVID-19 products from the marketplace and prevent many more from entering. This has also led to domain registrars to review and take down hundreds of websites selling fraudulent COVID-19 products.

But inevitably, when companies don't take adequate corrective action, like the case involving MMS, I mentioned previously, the agency will work with the Department of Justice and consider taking enforcement actions, such as seeking temporary restraining orders to prevent companies from continuing to sell their products. And we're working with a variety of federal partners to cover as much ground as possible to identify and remove these products from the marketplace and to hold accountable those bad actors who persist in illegal practices.

RADM Richardae Araojo: Ms. Rogers, how can consumers spot red flags? Are there keywords people need to be aware of?

Minerva Rogers: There are a few tips to spotting these fraudulent products. If a product is marketed to prevent or cure COVID-19, that is definitely a red flag. Currently, there are no FDA approved medicines to cure COVID. Often these fraudulent products have sleek branding and can appear reputable even to the trained eye. And you can find them in some very popular sites online like social media or in online marketplaces.

Some of these unlawful products have even been sold by individuals claiming to be physicians or healthcare provider or other professionals who may claim that they are in the know and that the FDA is enacting in their best interest of consumers. Also, fraudulent products are often sold using personal testimonials that maybe exaggerated or completely fake. We recognize it's challenging to know what information to believe sometimes, especially online.

FDA urges consumers, patients, and healthcare providers to stay vigilant during this pandemic and not purchase or use fraudulent COVID-19 products. If it sounds too good to be true, it probably is. If you're not sure about the product, it is important to ask your healthcare provider before buying.

RADM Richardae Araojo: The FDA recently authorized by Emergency Use Authorization certain COVID-19 vaccines. What would you like our listeners to know to protect themselves and their families from falling victim to health fraud?

CAPT Jason Humbert: Ma'am, the FDA has been working closely with federal partners like the Federal Trade Commission or FTC during the pandemic response. The FTC has easy tips on how to avoid COVID-19 vaccine scams, and these can range from scammers wanting consumers to pay for early access to the vaccine or to reserve a vaccine appointment. The FDA is not involved in vaccine distribution. We are responsible for authorizing or approving COVID-19 vaccines for use in the United States.

So if anyone is contacted directly by someone who says they are from the FDA, or they have a COVID-19 vaccine appointment, do not give them any information. This is a scam. People can visit their local and state health department website or the CDC website to get more information about vaccine distribution in their area. Also, any questions or concerns about vaccine distribution should be sent to your state government or local health department.

RADM Richardae Araojo: Can you give us an example of some of the steps FDA is taking to protect consumers against COVID-19 vaccine fraud?

CAPT Jason Humbert: We want to alert consumers that COVID-19 vaccines cannot be sold online. Unfortunately, the agency is aware of reports of COVID-19 vaccines offered for sale on online marketplaces. And so the agency is working with these marketplaces to remove such listings that are found or reported. The agency will also take appropriate action to remove fraudulent vaccines from the marketplace when discovered. For example, in recent weeks, an individual was arrested for claiming to be a biotech executive who was promoting an unproven injectable vaccine.

The agency has gone to great lengths to ensure that the vaccines available to the public are safe and effective. But we'll continue to take appropriate acts against those who are trying to circumvent regulations or federal law. Listeners should know the agency and its partners are working together to prevent or disrupt any sales or distribution of fraudulent vaccines. We also encourage all the listeners to report a potential COVID-19 drug or medical product scam to us through our reporting system, which is available in both English and Spanish.

RADM Richardae Araojo: Can you tell us where we can find more information about fraudulent COVID-19 products?

Minerva Rogers: Consumers can visit the FDA website to find the most up-to-date COVID-19 information. They can also visit our website to learn more about health fraud at www.fda.gov/healthfraud.

RADM Richardae Araojo: And how can people report a problem to your office?

Minerva Rogers: FDA encourages consumers to report potentially fraudulent products or vaccines to the agency. There are a couple of ways that consumers can report a problem. We have an online reporting system accessible from the FDA website, www.fda.gov, that is also available in Spanish. And as part of the COVID-19 response, FDA created a dedicated email address where consumers can report the sale of unlawful COVID-19 products. Another way to report is by contacting the local FDA consumer complaint coordinator and consumers can find the number on the FDA website.

Just type in on the search box “consumer complaint coordinators” to find one in your area.

RADM Richardae Araojo: CAPT Humbert, is there anything else you want our listeners to know?

CAPT Jason Humbert: Yes, ma'am. These are difficult times and bad actors are attempting to exploit this pandemic. So we want consumers to be smart, be aware, be safe. The best way to prevent getting sick is to avoid being exposed to the virus. Follow the recommendations of the experts at the CDC to prevent the spread of COVID-19 and take care of yourself and your loved ones. If you do get sick, talk to your healthcare provider about your treatment options and beware of fraudulent COVID-19 products.

RADM Richardae Araojo: CAPT Humbert and Ms. Rogers, thank you so much for a great conversation and for sharing these important resources and tips with our listeners. A list of the resources highlighted during this episode can be found on the FDA Health Fraud website at www.fda.gov/healthfraud. You can also follow the Health Fraud Branch on Twitter @FDA_ORA, for the latest news and information. For more information about the Health Equity Forum Podcast series, visit our website at www.fda.gov/healthequity.

While you're there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on Twitter @fdahealthequity. Remember, together we can create a world where health equity is a reality for all.

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