Listen

Sara Roach: Welcome to “Q&A with FDA,” from the FDA’s Division of Drug Information, where we aim to answer some of the most frequently asked questions that we’ve received from the public. My name is Dr. Sara Roach and today we will be discussing medication health fraud. Medication health fraud includes the marketing of medications with unproven, false, or misleading claims about their ability to diagnose, cure, mitigate, treat, or prevent a disease or condition.

Today we are joined by Cynthia Ng, J.D., Fraud Drugs Branch Supervisor within the Office of Compliance in FDA’s Center for Drug Evaluation and Research, or CDER. Cynthia, thank you for joining us today.

Cynthia Ng: Thanks for inviting me!

Sara Roach: We know that the use of medications marketed with unproven claims or products containing hidden drug ingredients can cause serious injury and even death. These quote unquote “treatments” are also often ineffective. What other risks are related to fraudulent drugs?

Cynthia Ng: Besides wasting money, consumers who take fraudulent drugs can be delaying potentially life-saving diagnoses and scientifically tested and proven treatments, because they believe they are taking something that is helping to treat their disease or condition, when in fact, they are not.

Sara Roach: Health fraud scams - they’ve been around for hundreds of years and capitalize on the desire for a quick fix or miracle cure. What are some of the health fraud scams you encounter most commonly in your work that health care providers should be aware of?

Cynthia Ng: There are quite a few. Some people try very risky products for enhancing their bodies or appearances. For example, some people have taken illegally imported products, such as Apetamin, to gain weight and achieve a certain physique. Apetamin contains cyproheptadine, a potent antihistamine that requires a physician’s prescription in the U.S., and may cause sedation, cognitive impairment, dizziness and low blood pressure. Others have injected themselves with unproven skin whitening or fat-dissolving products. These products have not been evaluated by the FDA and we have received reports of adverse reactions including permanent scars, serious infection, and skin deformities.

Another common area for fraudulent products is in the bodybuilding or sports performance space. Products marketed to enhance athletic performance may contain anabolic steroids or steroid-like substances, which pose serious health risks. Some of the most serious health risks include liver failure, infertility, or testicular shrinkage.

Then there are fraudulent products that claim to treat serious diseases like cancer, Alzheimer’s, and opioid addiction, just to name a few. These fraudulent products are particularly harmful because their use can lead to harmful consequences and delays in appropriate medical treatment.

Sara Roach: We often receive questions about medication health fraud products marketed for weight-loss and sexual enhancement. Tell us about these products and what to look out for.

Cynthia Ng: Yes, we see a lot of these products.

Consumers should watch out for weight loss products with dramatic claims or that promise fast results. The products are often marketed as “all natural” as well.

Some examples of products that made dramatic claims include Alfia Weight Loss Capsules which claimed that users could “lose 27 pounds in 30 days” or Miss Slim, which promised a “FAST RESULT” and that users could “lose an average of 6 pounds in 10 days.”

We’ve seen that some of these weight loss products may contain the hidden drug ingredient sibutramine, which is a controlled substance that was removed from the market for safety reasons. Some of these safety concerns include the drug ingredient’s ability to substantially increase blood pressure and heart rate. This can be especially dangerous for those with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

We have found that fraudulent products marketed for sexual enhancement often contain hidden drug ingredients as well. When approved medications are prescribed to treat sexual dysfunction, providers or pharmacists review important drug interactions to keep consumers safe. When people unknowingly use a fraudulent product that contains hidden drug ingredients, they are putting themselves at risk of dangerous interactions with other prescription drugs they may take. These ingredients can also lower blood pressure to dangerous levels.

Sara Roach: The FDA website has a Health Fraud Product Database that contains notifications about products we found to contain hidden ingredients. You can find a link to this database by clicking on our episode webpage at fda.gov/QAwithFDA - it’s located in the Resources at the bottom of this page.

Cynthia Ng: Yes, consumers can check to see if a product they are thinking of taking is on the list. However, FDA can’t test everything, and the list is just a small fraction of potentially hazardous products. We recommend that consumers talk to their healthcare providers before taking products in these categories. These are just a few examples but gives an idea of what to look out for at least in these popular treatment areas.

Sara Roach: A question we receive a lot is, how are these products entering the U.S. market? Can you talk a bit about where these products come from?

Cynthia Ng: Fraudulent drugs can originate from various locations both within the United States and worldwide. Believe it or not, many of these products are smuggled or shipped through international mail. To avoid detection, they are often falsely declared to customs as different items, such as research chemicals, tea, or handbags. The network of individuals and businesses involved in distributing these products is diffuse, fragmented, and challenging to track. There are often intricate supply chains involving distributors, wholesalers, and retailers. And many of the companies are not registered with FDA and operate out of residential settings.

Sara Roach: So it’s essential to remain vigilant regardless of where one makes their purchases.

Cynthia Ng: Absolutely. Fraudulent drugs may be offered for sale through various channels, including websites, large online marketplaces, gas stations, grocery stores, and convenience stores. People may think that just because a product is on a store shelf or available from a large retailer or well-known marketplace that the product is legally marketed. However, this is not always the case and consumers need to be careful. For example, we have sent numerous warning letters to online marketplaces like Amazon and Walmart for illegal drugs that were sold on their platforms.

Sara Roach: Can you share with our audience the importance of reporting suspected fraudulent products to FDA? We are asked frequently about how this process works and consumers may be skeptical that their report can make a difference.

Cynthia Ng: Reporting problems to the FDA helps us identify dangerous and/or illegal products that may be on the market. We have an online “Reporting Unlawful Sales of Medical Products on the Internet” portal where anyone can report a product they suspect may be fraudulent. Reports can be submitted anonymously, or you can include your contact information. The link to this portal is again located at the bottom of the episode webpage for this podcast.

Because scammers promote their products with savvy marketing tactics that often target specific populations via the web and email, but also by other means, our web portal allows reporting of all these types of locations. With your report, you can include screen shots, links, or other evidence of suspected health fraud.

We carefully review every report submitted to the online portal and appreciate help from the public in alerting FDA to potentially unlawful sales. By reporting, you can help the agency prevent others from falling victim to fraudulent products.

Sara Roach: We also receive reports from individuals who have taken a product they now suspect to be fraudulent, and they have experienced an adverse event. Adverse events related to potentially fraudulent medication products can be submitted to FDA via MedWatch, FDA’s Safety Information and Adverse Event Reporting Program. It’s easy and you can report online or through the mail. Cynthia, can you share an example of safety concerns FDA has received related to a fraudulent product?

Cynthia Ng: Sure. One that comes to mind is when FDA learned that more than 30 consumers had experienced a serious health effect after using fraudulent products with “Artri” or “Ortiga” in the product name, promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. FDA laboratory analyses revealed certain Artri and Ortiga products contained undeclared drug ingredients, including the corticosteroid dexamethasone, the anti-inflammatory drug diclofenac, and the muscle relaxant methocarbamol. These drug ingredients, which are not listed on the product label, can also interact with other drugs a consumer is taking. We received reports of harmful effects including liver toxicity, sudden weight gain, serious gastrointestinal damage including bleeding and ulceration, increased blood glucose levels, adrenal dysfunction, and other serious conditions. Some of these problems could be life threatening or fatal, and we in fact received reports of death, so it was very concerning.

Another example is salves or creams (commonly known as “black salve”) claiming to cure cancer, boils, moles, and skin tags. In reality, salve products containing corrosive ingredients, including black salve, are not approved by FDA to treat or cure any skin condition, and contain potentially dangerous ingredients that may destroy the skin and result in permanent disfigurement, tissue necrosis, and infection. FDA has identified numerous adverse events associated with black salve products, and we are aware of at least one death that resulted from a person who opted to use a corrosive salve rather than pursue proven cancer therapies.

Sara Roach: With so many health fraud scams out there, it seems like the reporting would far outpace our ability to investigate or take action. How does FDA approach the overwhelming volume of suspected medication health fraud products on the market today?

Cynthia Ng: The FDA employs a multi-faceted approach to protect the public from fraudulent drugs. We actively monitor the marketplace for fraudulent drugs that may be in violation of the law. Additionally, our office reviews reports from the reporting systems mentioned earlier, such as the online portal and MedWatch, as well as reports from poison control centers, and medical literature. FDA actively searches for new concerns as well. We can collect samples from retail or online sellers, manufacturers, imported shipments and conduct product testing to identify hidden drug ingredients. Unfortunately, FDA cannot test and identify all the products on the market that have potentially harmful contaminants in order to assure their safety.

Sara Roach: Can you describe some of the actions that FDA can take when a medication health fraud product is identified?

Cynthia Ng: Sure, there are several different ways in which we take action to protect public health when we identify a fraudulent drug product. One way we can take action is by sending a Warning Letter to the company that owns, manufactures, or distributes the product.

In addition to warning letters, we can issue import alerts to try to keep that product from entering the country in the future. Import alerts inform the FDA’s field staff at ports of entry as well as the public that these products are of significant concern.

The agency also works with the Department of Justice to seize products and obtain injunctions, and the FDA's Office of Criminal Investigations also investigates firms who sell fraudulent products. And there are also drug recalls, which can help protect the public from a defective or potentially harmful product.

It’s impossible though to address each and every fraudulent product available to consumers, and enforcement actions and consumer advisories for unapproved products only cover a small amount of the potentially hazardous fraudulent products marketed to consumers. It is therefore important that consumers remain vigilant and have open discussions with their health care providers.

Sara Roach: Can you share with our audience some more information about FDA’s health fraud product database that you mentioned before?

Cynthia Ng: The Health Fraud Product Database maintained by FDA currently includes over 1,000 unapproved products with violations. But keep in mind though that this database represents only a small fraction of the potentially hazardous products on the market, meaning that the absence of a product from the database does not in any way guarantee its safety or that it is legally marketed.

Sara Roach: Are you familiar with the recently released Q&A episode on Navigating the World of Online Pharmacies? In this episode we discussed buying medicines safely online and tips for identifying reputable online pharmacies.

Cynthia Ng: Yes, that was a great episode. We share the common goal of reminding the public that it is essential to remain vigilant regardless of where you make your purchases and to remember that the presence of fraudulent drugs is not limited to specific locations or platforms. We have multiple webpages available to educate the public about how to spot scams and how to identify products that are potentially unlawful. We provide some examples of scams to help with this.

Watch out for claims that a product can do it all, marketing campaigns that rely heavily on personal testimonials without credible evidence, products that offer miracle cures or quick fixes, and products that claim to be alternatives to FDA-approved drugs or promise to have similar effects to approved prescription drugs.

Sara Roach: And healthcare professionals and consumers can ask the agency about a suspected product by emailing druginfo@fda.hhs.gov or calling us at 855-543-3784 or 301-796-3400.

Cynthia, thank you for being here. Is there anything else you’d like to share today?

Cynthia Ng: At the end of the day, I always recommend that consumers discuss all the products they are taking and their medical conditions with their healthcare provider. Health care providers can make personalized recommendations and help ensure that patients and consumers are accessing safe and effective treatments.

Sara Roach: Thanks for listening to “Q&A with FDA”. The full podcast and transcript of this recording is available at fda.gov/qawithfda. Many of our episodes offer continuing education credits for health care professionals, so be sure to visit this webpage for more details.

If you are looking for additional learning or continuing education credit opportunities, including live and home study webinars, you’ll also want to check out fda.gov/CDERLearn and fda.gov/DDIWebinars.

And if you have questions about this episode, or anything drug-related, email us at druginfo@fda.hhs.gov.

Resources

• Medication Health Fraud
• Medication Health Fraud Questions and Answers
• Health Fraud Product Database
• FDA Actions to Stop Medication Health Fraud
• Medication Health Fraud for Specific Diseases and Conditions
• 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams
• Reporting Unlawful Sales of Medical Products on the Internet
• About BeSafeRx