Wednesday, November 17, 2010

FDA issues warning letters to makers of caffeinated alcoholic beverages

The FDA today issued warning letters to four companies that make caffeinated alcoholic beverages.  This came nearly a year after the agency asked 30 manufacturers to provide their rationale, and supporting data and information, for concluding that their use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned.

“FDA does not find support for the claim that the addition of caffeine to these  alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

According to the FDA, its action follows a scientific review by the Agency.  FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers.  FDA also performed its own independent laboratory analysis of these products.

Although the warning letters were sent to only four companies who did not respond to the agency's letter last year that asked for the safety data, it appears that the agency is on the path to ban all caffeinated alcoholic beverages.

Tuesday, November 2, 2010

Latest regulatory trends from RAPS conference

There were several excellent speakers at the RPAS (Regulatory Affairs Professionals Society) annual conference in San Jose last week.  They represented regulatory professionals in the private and public sectors, both domestically and abroad.  Here are some of the take-away messages from the speakers:
  • FDA is stepping up enforcement.  This shouldn't come as a surprise if you've been following the agency's enforcement actions lately.  In his speech to the food and dietary supplement industry, FDA's Chief Counsel Ralph S. Tyler stated that the agency has just began its enforcement efforts and that more are yet to come.  Among the areas of concern are the good manufacturing practices (GMP) regulations for dietary supplement products, as well as the notification requirements for new dietary ingredients.  The agency also intends to hold individual more accountable for violations, which would result in more criminal prosecutions of company executives and even employees.
  • FTC is stepping up enforcement.  Similarly, the FTC is stepping up enforcement in the area of claim substantiation.  The FTC will be looking at scientific data more closely to determine whether they support claims made about a product.   Companies should pay more attention to testimonials, because according to the government, they are never substantiated. 
  • Companies are very interested in the Chinese market, but are frustrated by the regulatory framework there.  Among the conference speakers were five officials from the Chinese State FDA (SFDA), who provided an overview of the medical device approval process in China.  This presentation was one of the popular ones at the conference, and the numbers and types of the questions asked at the end of the presentation showed many companies (large and small) are very interested in the Chinese market, and yet are frustrated with the lack of transparency in the approval process.  Here are some of the policies that can cause frustration:
    • According to a SFDA official, if a foreign company manufactures a medical device in China, the company will have to export the finished product out of China.  However, if a Chinese company puts its own label on the same product, it will be able to sell the device in China.  This policy seems to have little to do with safety and efficacy.  
    • Also according to the same official, a medical device imported into China will not receive SFDA approval if the device has not received market approval in the country of origin.  The message seemed to be: if this device is not good for your country, it's not good enough for China.
    • Questions were asked about whether the SFDA would accept data from clinical trials done outside of the China.  The answer was as clear as water - generally no, but we will decide on a case by case basis, but if we decided you need to do more clinical trials, you need to conduct them in China.  
    • Questions were asked about whether the SFDA would meet with companies to discuss their products before the companies submit their applications for approval of their products.  The answer was that the SFDA holds a "open forum" every Thursday during which anyone can participate in a Q&A session with the agency to discuss any regulatory issues.  According to the SFDA official, no appointment is required and people can participate by phone.  So much for confidentiality. 

I am still reviewing my notes and materials from the conference, and plan to blog about other interesting topics I ran across there.