USA
FDA sets date for CBD meeting for May
The US Food and Drug Administration has scheduled an all-day meeting on May 31 to discuss CBD and hemp and their regulatory concerns.
The announcement came at the same time as the Agency sent warning letters to three companies marketing CBD products with disease claims. The warnings were the first issued under FDA’s de facto ‘enforcement discretion’ policy.
At a recent Senate hearing, outgoing FDA Commissioner Scott Gottlieb, MD, said FDA is not moving against any marketer of CBD products based solely on the uncertain regulatory underpinning of the ingredient.
Gottlieb noted: “We’re using enforcement discretion right now. I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line’ claims.”
For more on this, please click HERE.
Europe
Omega-3 firms’ appeals in vain as EMA confirm medicine ‘not effective’ post heart attack
The European Medicines Agency (EMA) confirmed that omega-3 fatty acids are not effective in preventing further cardiovascular problems in patients who have had a heart attack, effectively reversing a position adopted by several EU countries in 2000.
Reviewing data from the open-label ‘GISSI Prevenzione’ study performed in 1999 (which supported the initial authorization) and more recent randomized controlled clinical trials, retrospective cohort studies and meta-analyses led to the conclusion that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, the beneficial effects were not confirmed in more recent randomized controlled trials.
Findings from the review do not affect the authorization of omega-3 fatty acid medicines for the treatment of high levels of triglycerides in the blood or hypertriglyceridemia.
For more on this, please click HERE.
Asia
NZ researchers re-dress imbalance by ramping up efforts to meet nutritional needs of female athletes
Scientists in New Zealand are beginning to shift their focus from male to female athletes in a bid to redress in imbalance in sports nutrition research.
A recent review, published in the Strength & Conditioning Journal, highlighted the harmful effects of ignoring female athletes' nutritional needs, along with the dearth of existing research on those needs.
Lead author Dr Katherine Black from the University of Otago told our Asian edition that an overwhelming majority of studies on athletic nutrition so far have focused on male athletes.
However, the increasing number of female athletes necessitates more research on their specific nutritional needs, which differ significantly from those of male athletes.
“We've observed that a lot of female athletes don't consume sufficient amounts of food and drink to meet their energy needs, especially after exercise, which is putting their health at risk.
“Health-related factors we were looking out for included disruptions to the menstrual cycle, which we saw across all age groups. The youngest athletes could develop such issues due to pressure to perform, and middle-aged, peri-menopausal active women could also be under pressure from body image issues.”
