FDA warns of fraudulent and unapproved flu products

As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies.

“This year the flu has been widespread, impacting millions of patients across the country, and leading to a new record number of flu-related hospitalizations,” said FDA Commissioner Scott Gottlieb, M.D. “We understand the toll this year’s flu season has taken on peoples’ lives. As the flu continues to make people sick — and even cause deaths — unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the FDA to be safe and effective. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. We’re advising consumers on some of the telltale signs to look for when trying to spot flu products that may be fraudulent. All of us must also continue to be diligent in doing our part to prevent the spread of flu however possible. People who are sick with flu-like symptoms and those who are at high risk of serious flu complications should see a health care professional as soon as possible to see if they should be treated with antiviral drugs.”

Consumers should be aware that there are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion and other symptoms typically associated with the flu. Products sold online are fraudulent if they claim to prevent, treat or cure the flu, and have not been evaluated by the FDA for that intended use.

These flu claims may indicate that an OTC product is fraudulent:

• reduces severity and length of the flu;
• boosts your immunity naturally without a flu shot;
• safe and effective alternative to the flu vaccine;
• prevents catching the flu;
• effective treatment for the flu;
• faster recovery from the flu; or
• supports your body's natural immune defenses to fight off the flu.

Health fraud scams waste money, lead to delays in getting a proper diagnosis and treatment, and may even lead to more serious injuries or death. The FDA routinely warns the public about health scams and has recently taken action against companies promoting and selling unproven treatments for cancer, opioid addiction and other illnesses. However, there are numerous unapproved and potentially unsafe products that continue to be sold directly to consumers in part because companies or individuals can move their marketing operations to new websites.

Online pharmacies present another opportunity for scammers to take advantage of unsuspecting consumers. Online pharmacies may claim to sell prescription antiviral drugs, such as Tamiflu, at reduced prices or without a prescription. The FDA advises consumers to avoid purchasing products making such claims.

Beware of online pharmacies that:

• allow you to buy prescription medicine without a prescription from your health care provider;
• do not have a U.S. state-licensed pharmacist available to answer your questions;
• offer very low prices that seem too good to be true; or
• are located outside of the U.S. or ship worldwide.

These pharmacies often sell medicines that can be dangerous because they may:

• have too much or too little of the active ingredient you need to treat your disease or condition;
• not contain the right active ingredient; or
• contain wrong or other harmful ingredients.

Legitimate online pharmacies exist, but so do many websites that look like professional and legitimate pharmacies, but are actually fraudulent. The FDA recommends consumers buy prescription drugs from their local pharmacy or only through an online pharmacy that requires a valid prescription from a doctor or other authorized health care professional and is licensed by the state board of pharmacy (or equivalent state agency) where the patient is located.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.