FDA warns of imposters sending consumers fake warning letters – Scammers are targeting consumers who have purchased medicines online (July 13, 2018 FDA news release)
- The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone. Instead of receiving the medicines they paid for, consumers have received fake warning letters, generally addressed to a “Sir/Ma’am.” The letters allege the order has been intercepted and threaten that “we are still investigating the root of this delivery & necessary legal steps will be taken if we found [sic] out any suspicious activity on your end.”
- In reality, FDA does not typically take action against individuals purchasing a medicine online. FDA typically sends warning letters directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products. It would be highly unusual for FDA to send any official communication to an individual consumer.
- FDA cautions of the risks of purchasing medicines from illegal online pharmacies. Dangers include receiving counterfeit medicines or being the victim of scams such as the current one. FDA advises that medicine can be purchased online safety by buying only from U.S.-licensed pharmacies that require a prescription.
Dr Pepper Hit With Suit Over Real Ginger Campaign – Law360 (subscription to Law360 required)
- Janet Childers, the named plaintiff in a proposed class action lawsuit in Texas, alleges that labels claiming ‘Made with Real Ginger’ on Canada Dry Ginger Ale are misleading because the product contains no real ginger. Childers further alleges that the company added only a miniscule amount of ginger flavor extract (200 parts per million) so as not to impact the flavor (produced by artificial ingredients) and for the purpose of marketing the drink as a healthy alternative to soft drinks, despite the ginger ale having the same high sugar content as other sodas. Childers et al. v. Dr Pepper Snapple Group Inc. et al., case number DC-18-08724, was filed in the District Court of Dallas County, Texas on July 5, 2018. Childers seeks compensation, punitive damages, and an injunction to prevent Dr Pepper from selling ginger ale with the offending labels.
- Dr Pepper also faces a federal class action lawsuit in California over the ‘Made with Real Ginger’ claim. Class certification was granted June 25, 2018 in Jackie Fitzhenry-Russell et al. v. Dr Pepper Snapple Group Inc. et al., case number 5:17-cv-00564, in the U.S. District Court for the Northern District of California. Another federal class action lawsuit over the ‘Made with Real Ginger’ claim (Webb v. Dr Pepper Snapple Group Inc. et al., case number 4:17-cv-00624, in the U.S. District Court for the Western District of Missouri) was dismissed by the plaintiff voluntarily and without explanation on June 19, 2018.
- Manufacturers of other products containing only the extract of a touted ingredient should pay close attention to the ‘Real Ginger’ lawsuits.
- The U.S. Food and Drug Administration (FDA) announced yesterday, July 2, 2018, an opportunity for public comment on a proposed survey of the manufacturing practices and standards employed across the cosmetic industry to ensure product quality and safety. The survey is intended to provide the industry with a systematic and detailed study of the current manufacturing practices, a study which, to date, has never been undertaken by FDA.
- The voluntary survey would collect a variety of data ranging from general company information about the product manufacturer (such as production and volume, approximate revenue, company size), as well as data on the following practices: written procedures and documentation relating to manufacturing, processing, maintenance, and training; buildings and equipment management, including cleanliness, sanitation, pest control practices, and equipment maintenance; materials and manufacturing, including inventory management and standard operating procedures; and quality control/product testing, including scope, quality testing, rejected products or complaint response, and other corrective actions. The comment period will be open until August 31.
- Some stakeholders and consumer groups have been calling on lawmakers and regulators to reform cosmetics regulations for years, and this initiative could signal that regulatory modifications lie ahead. Five years have passed since FDA issued its draft guidance for Cosmetic Good Manufacturing Practices, which was originally issued on February 12, 1997 and was later revised in April of 2008 and again in June of 2013.
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