GermBullet Flu and Cold Treatment is Subject of FDA Warning By Tod Aronovitz | 02/07/13 | 0 Comment

GermBullet® products marketed by Flu & Cold Defense LLC of Boca Raton, Florida, are “not generally recognized as safe and effective for … labeled uses,” according to a recent Food & Drug Administration (FDA) warning letter.

Promoted as a “germ fighting inhaler,” GermBullet was described as offering organic ingredients free of zinc or alcohol. Consumers were encouraged to use the GermBullet inhaler before, during or after exposure to germs in crowded venues like airports, theaters, hospitals or cruises. The product claimed to keep users healthy by delivering a “higher probability of effectively combating germs.”

Not true, says the FDA, which alleges that Flu & Cold Defense made several false and misleading statements. Specifically, the FDA warning letter states:

  • The FDA does not recognize any GermBullet independent product testing, as claimed by the promoter
  • Sale of GermBullet without having an FDA-approved application in effect is against the law
  • A layman cannot use GermBullet safely for its intended uses

The company’s two websites, www.germbullet.com and www.nsaroma.com are under reconstruction pending compliance with the FDA requirements.

Click on the link to read the FDA Warning Letter to Flu and Cold Defense LLC.

Product Liability Risks in Healthcare Products

Product liability is an area of the law that holds manufacturers, distributors, and retailers responsible for injuries caused by the products they make or distribute to the public. Under the law, manufacturers and suppliers of products have a duty to ensure that those products are safe for their intended uses and do not contain anything that would cause injury to a user.

Common examples of product liability marketing defects include confusing, hard-to-follow instructions or a manufacturer’s failure to warn consumers of potential dangers of the product.

The FDA’s warning letter to Flu & Cold Defense LLC in regard to GermBullet is a real-life example of potential product liability concerns.

ARONOVITZ LAW: Representing Florida Consumers in Product Liability Cases

The Miami product liability law firm of ARONOVITZ LAW pursues justice for Florida citizens who have been injured by the wrongful actions or omissions of another individual, government agency, or corporation. We can assist you with civil litigation, consumer class action litigation, whistleblower cases, medical malpractice, product liability, and wrongful death.

Contact Miami, Florida product liability attorney Tod Aronovitz for a confidential discussion of your case.