Mylan pushes forward in its Perrigo takeover bid
CRN supports FDA action against marketing pure powdered caffeine to consumers
WASHINGTON — The Council for Responsible Nutrition this week came out in support of the Food and Drug Administration taking action against marketing bulk pure powdered caffeine to consumers and its issuance of warning letters to five powdered caffeine distributors.
“We have been, and continue to be, supportive of FDA’s efforts in this area to educate consumers about the potential dangers of pure powdered caffeine,” CRN’s regulatory counsel Rend Al-Mondhiry said. “We share the agency’s concerns about the safety of this product being sold directly to consumers. In fact, earlier this year, CRN updated its voluntary guidelines for caffeine-containing products to include restraints against the sale and marketing of pure powdered caffeine.”
Though the council’s guidelines don’t limit the sale or marketing of bulk pure powdered caffeine on a business-to-business level, they do note that their members shouldn’t market directly to consumers.
“We hope the companies receiving the warning letters will take these concerns seriously, and if not, we look to FDA to take the next steps under the law,” Al-Mondhiry said.
Report: Omega-3 supplements don’t slow cognitive decline
NEW YORK — The Journal of the American Medical Association recently published results from a clinical trial that found that omega-3 supplements did not slow cognitive decline in older people. The National Institutes of Health tracked 4,000 patients over a five-year period.
“Contrary to popular belief, we didn’t see any benefit of omega-3 supplements for stopping cognitive decline,” NIH’s Dr. Emily Chew said.
Chew led the Age-Related Eye Disease Study, which established that a daily formulation of certain antioxidants and minerals can help slow age-related macular degeneration, according to NIH.
But when omega-3 fatty acids were added to this formulation for a later study, called AREDS2, they did not make a difference.
All participants in this study had early or intermediate AMD, were 72 years old on average and 58% were female. They underwent cognitive function tests at intervals of two years, and cognition scores decreased over time.
Some research has examined the potential benefits of docosahexaenoic acid, an omega-3 fatty acid, for Alzheimer’s disease. Studies in mice found that DHA reduces beta-amyloid plaques in the brain, but a clinical trial of DHA indicated no impact on people with mild to moderate Alzheimer’s disease, the NIH said.
“The AREDS2 data add to our efforts to understand the relationship between dietary components and Alzheimer’s disease and cognitive decline,” Lenore Launer, senior investigator at the Laboratory of Epidemiology and Population Science at the National Institute on Aging, said. “It may be, for example, that the timing of nutrients, or consuming them in a certain dietary pattern, has an impact. More research would be needed to see if dietary patterns or taking the supplements earlier in the development of diseases like Alzheimer’s would make a difference.”