This week’s big news across the global nutrition and supplements industries includes Robert F. Kennedy Jr.‘s call to “close the GRAS loophole”, EFSA concluding that monacolins from red yeast rice are unsafe at any dose and Holland & Barrett exploring “new and exciting opportunities” in Singapore.
RFK, Jr. seeking to eliminate self-affirmed GRAS
The big news in the United States this week was Robert F. Kennedy Jr. directing the acting FDA commissioner to explore the elimination of the self-affirmed GRAS pathway for ingredients.
Generally Recognized as Safe (GRAS) is a determination that a substance added intentionally to food is deemed to be safe under its intended conditions of use.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Secretary Kennedy said in a press release.
“Eliminating this loophole will provide transparency to consumers, [and] help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe.”
HHS also stated that it is seeking to work with Congress to explore ways legislation can “completely close the GRAS loophole.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), urged industry to not panic, noting that this was “exploratory at this stage on “how the GRAS process can be ‘healthier’” which deserves a look, especially as it relates to enforcement.”
EFSA publishes ‘major blow’ as monacolins deemed unsafe at any dose
The European Food Safety Authority (EFSA) has concluded that monacolins from red yeast rice could pose significant health risks, even low intake levels.
The scientific opinion published by EFSA’s Panel on Nutrition, Novel Foods and Food Allergens reviewed data on the safety of monacolins, with the panel concluding that consuming monacolin K, the active compound in RYR, at doses as low as 3 mg per day could lead to severe adverse effects, including rhabdomyolysis (a serious muscle condition) and liver damage.
The report also highlighted inconsistencies in the composition of RYR supplements, with variations in monacolin content and potential contaminants, and advised consumers to exercise caution when using these supplements, particularly those with existing health conditions.
Luca Bucchini, food risk scientist and expert in food regulation, said: “A ban, with no threshold, is the most likely scenario despite the long tradition of use of RYR in traditional cuisine, an aspect that EFSA has ignored.”
Holland & Barrett explores Singapore opportunities after franchisee closure
British wellness retailer Holland & Barrett is exploring “new and exciting opportunities” in Singapore after its franchise partner shut down all brick-and-mortar stores across the island-state.
Jay Gee Health (PTE) Ltd had operated as the franchise partner for Holland & Barrett in Singapore for 16 years. As of July 2024, there were 11 Holland & Barrett outlets in Singapore.
Holland & Barrett said it was disappointed in the turn of events and that it was exploring new ways to continue serving the Singapore market.
“We share in our customers' disappointment at this development and recognize the impact it may have on those who rely on our products,” the company shared.
“We remain committed to finding the best ways to bring our expertise and trusted products to the market and are actively exploring new and exciting opportunities to continue serving the health and wellness needs of Singaporean customers. We will share further details in due course.”
