FDA Cracks Down on Flu Product Scammers

By: Gary Coody, R.Ph.

The severity of this year’s flu season has brought out the scammers promoting fraudulent flu products.

Gary Coody, R.Ph., is FDA’s national health fraud coordinator, FDA Office of Regulatory Affairs, Office of EnforcementThrough our careful monitoring of the Internet, FDA has identified numerous untested and unapproved products being illegally marketed with deceptive claims that they prevent, treat, or cure the flu.

When FDA staff find these fraudulent products, we send a warning letter to the sellers describing how the product violates federal law and instructing them to respond in writing with a description of how they intend to address the violations. If a seller does not respond within 15 days and continues to sell the product without correcting the violations, the products being sold by U.S. companies may be seized, FDA may notify law enforcement officials in the country abroad where a seller maintains its operation, or the federal government may take other legal actions.

In the past week, the agency has sent nine warning letters to firms marketing fraudulent flu-fighting products, including an online seller marketing a product that claims to be an alternative to the flu vaccine, three firms marketing dietary supplements online (letters co-signed by the Federal Trade Commission), and a firm selling an oral spray online and in major retail stores.

The remaining four warning letters were issued to online firms selling what they claim to be generic and other unapproved versions of oseltamivir phosphate, the active ingredient in Tamiflu. Tamiflu is an FDA-approved brand-name drug, but no generic Tamiflu is approved in the U.S.

FDA advises consumers to beware of online “pharmacies” selling generic versions of Tamiflu. If you buy one of these products, you don’t know what you’re getting—it could be counterfeit, contaminated, or not stored properly to maintain quality. It could also have the wrong active ingredient or no active ingredient at all.

Some of the other fraudulent claims addressed in the warning letters include:

  • “the most effective alternative to the flu shot”
  • “natural health and strength can still be yours without flu shots”
  • “fight cold and flu – naturally!”
  • “safeguard you from deadly flu viruses.”

Our concern is that a consumer will buy or use a fraudulent product advertised as an “alternative to the flu vaccine” instead of getting the approved vaccine. The vaccine is the best way to prevent getting the flu.

Any time there is a large outbreak of disease, fraudulent products appear on the market. Bogus remedies were rampant during the 1918 flu pandemic, commonly known as the Spanish flu, which killed an estimated 675,000 Americans. Fast forward to 2009, when FDA sent out more than 100 warning letters to sellers fraudulently promoting their products to prevent the H1N1 (swine) flu.

Today, when a health threat emerges, fraudulent products appear almost overnight because the Internet and social media such as Facebook and Twitter have accelerated how quickly hucksters can reach the unsuspecting public.

FDA can’t track down all of these fraudulent products, so consumers need to beware of unapproved products that make false claims. When in doubt about a product, talk to your doctor, pharmacist, or other health care professional.

For more information about health fraud scams, visit www.fda.gov/healthfraud.

Gary Coody, R.Ph., is FDA’s national health fraud coordinator, FDA Office of Regulatory Affairs, Office of Enforcement

Flu Vaccines Still Available; Supplies Being Monitored

By: Margaret A. Hamburg, M.D.

There is still time to get an influenza vaccine that could protect you during the remainder of the 2012-2013 flu season.

Margaret Hamburg, M.D.FDA has approved influenza vaccines from seven manufacturers, and collectively they have produced an estimated 135 million doses of this season’s flu vaccine for the U.S. So far, more than 128 million of those doses have been distributed, though not all of those doses have been administered yet, according to our sister agency, the Centers for Disease Control and Prevention (CDC).

We have received reports that some consumers have found spot shortages of the vaccine. We are monitoring this situation and will update you at our Website and at www.flu.gov.

Consumers who are planning to be vaccinated can visit the latter site, click on “Flu Vaccine Finder,” enter their zip code and find a list of the clinics, supermarkets, pharmacies and other vaccine providers in their neighborhoods. Before you go, it’s wise to call ahead to confirm availability.

Health care providers can also search for vaccine by using the Influenza Vaccine Availability Tracking System (or IVATS), which is available online at http://www.preventinfluenza.org/ivats/ivats_healthcare.asp.

If you already have the flu, be assured that FDA is working to make sure that medicine to treat flu symptoms is available for all who need it. We do anticipate intermittent, temporary shortages of the oral suspension form of Tamiflu—the liquid version often prescribed for children—for the remainder of the flu season. However, FDA is working with the manufacturer to increase supply and reminding health care professionals that FDA-approved instructions on the label provide directions for pharmacists on how to compound a liquid form of Tamiflu from Tamiflu capsules.

Any Tamiflu shortages should be reported to FDA’s Center for Drug Evaluation and Research at drugshortages@fda.hhs.gov.

The flu season usually peaks in January or February, but can extend as late as May. CDC recommends that all adults and children who are at least 6 months old receive a flu vaccine each year, with fall being the optimal time to get it. It takes about two weeks for the vaccine to “kick in,” meaning the time it takes for your body to develop an immune response to provide protection from the flu.

Although the last year’s flu season was relatively mild, this season is turning out to be more severe. On the positive side, the vaccine is well matched this season to the circulating virus strains that are causing influenza. FDA’s preparations for this flu season began last year. In February, working with the World Health Organization and CDC to review influenza disease surveillance and laboratory data, and with the input of our advisory committee, FDA selected the influenza strains for the vaccine that is currently being used in the U.S.

So if you haven’t been already, get vaccinated. And mark your calendars for next fall; plans for the 2013/2014 flu season and the vaccine that will fight it are already underway. 

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration