FDA Corner – Interview with Commander Jason Humbert

Posted: June 2017

FDA Warns of Fraudulent Cancer Drugs

On April 25, 2017, the US Food and Drug Administration (FDA) issued warning letters to 14 companies regarding more than 65 products being marketed with unproven or fraudulent claims. The products identified included pills, topical creams, ointments, oils, drops, syrups, teas, and a thermography device.1

The marketing and sale of fraudulent health products are serious issues that pose risks to consumers, particularly those coping with a serious diagnosis like cancer. Such treatments are often promoted with claims that they are “natural” remedies or that a single product can treat multiple conditions or diseases. The sale of untested and unapproved drugs is facilitated by the Internet, which allows those behind these products to easily change brand and company names and otherwise evade regulatory oversight.

The recent spate of warning letters is the product of a deliberate investigation by the FDA to identify products being deceptively marketed on the Internet and on social media platforms as cures, treatments, or diagnostics for cancer. The search was a collaboration between the FDA’s Office of Regulatory Affairs, the Center for Food Safety and Applied Nutrition, and the Center for Drug Evaluation and Research. IASLC Lung Cancer News spoke with Commander Jason Humbert, a Senior Regulatory Operations Officer at the FDA’s Office of Regulatory Affairs, about the efforts to identify and eliminate fraudulent products on the market.

How does the FDA identify and investigate fraudulent products being marketed to treat cancer?
The FDA considers a number of factors when determining whether a product’s labeling is in violation of the Federal Food, Drug, and Cosmetic Act. In general, firms cannot claim that their products cure, mitigate, treat, or prevent cancer unless the FDA has determined the product is safe and effective for those intended uses.

The FDA monitors the marketplace— including social media, websites, and brick-and-mortar stores— for potentially fraudulent products (for example, products that may be unsafe or products about which the manufacturer makes false or misleading claims) through a variety of tactics such as market surveys, label reviews, reviewing adverse event reports, and testing of products.

It’s important to note that the FDA does not do this alone. Other state and federal agencies such as state Attorneys General offices, the Federal Trade Commission, and the Department of Justice also take actions against companies making false marketing claims.

What consequences are faced by the companies that received warning letters from the FDA in April? Are they required to immediately stop marketing the suspected drugs? Are fines involved?

The companies have 15 days from receiving a warning letter to correct the violations or to provide a plan to the FDA for how they will correct the violations. Since these particular violations pertain to marketing claims, corrective action is likely to involve removing the claims from their labels and marketing materials.

If the companies fail to resolve violations cited in the warning letters, they may be subject to further FDA action, including seizure of illegal products, injunctions, and possible criminal prosecution.

In addition to the need to correct the violations outlined in the warning letters, the companies are under an ongoing requirement to comply with all applicable FDA requirements such as Good Manufacturing Practice regulations.

Are fraudulent cancer drugs a bigger or smaller problem than in the past, and why?
Over the past decade, the FDA has sent more than 90 warning letters to companies marketing hundreds of fraudulent products making cancer claims. With the ongoing popularity of online sellers and social media sites, consumers are regularly exposed to online marketing tactics and direct-to-consumer product sales, including those that claim to diagnose, treat, or cure cancer. Due to the nature of online marketing, some companies attempting to avoid compliance with FDA law simply start new websites and rename their fraudulent products. This is why the FDA urges consumers to remain vigilant and to protect themselves against health fraud by not purchasing these products and by always discussing cancer treatment options with their health care provider.

What other steps is the FDA taking to reduce the sales of these fraudulent therapies?
In general, if companies fail to resolve violations cited in warning letters that they receive, the FDA can and has taken further action, including seizure of illegal products, injunction, and criminal prosecution. As one example, in 2015, the FDA was granted a permanent injunction against a company illegally marketing a handheld laser device as a treatment for cancer and dozens of other conditions after the company and its representatives ignored FDA’s warning letter and continued to illegally market and distribute its devices. The Department of Justice later charged three individuals, and a fourth individual agreed to plead guilty to conspiracy charges in a related criminal case.

Far from being relegated to the distant past of “patent medicines,” products making false claims to diagnose and treat cancer continue to be sold to patients who are often seeking a magic bullet for difficult-to-treat tumors. These fake drugs pose a risk of unknown interactions with clinically proven treatments, putting patients at increased risk, and some patients may choose products falsely promising a miracle cure over more unpleasant treatments.

That the FDA continues to issue warning letters regularly underscores the crucial need for consumers to remain vigilant and educated about fraudulent cancer cures, which the FDA addresses by disseminating consumer information using media outlets, Consumer Updates, and information on FDA.gov, and working with consumer and trade groups.

1. FDA takes action against 14 companies for selling illegal cancer treatments. FDA Press Release. April 25, 2017. Available at: https:// www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm554698.htm.