USA
FDA plans April meeting to explore new CBD regulations
The big news from the US this week was FDA Commissioner Dr. Scott Gottlieb’s announcement that the agency is planning a public meeting in April to initiate a rule making procedure on CBD.
The goal is to create “an appropriately efficient and predictable regulatory framework for regulating CBD products,” he said in a speech to a meeting of state agriculture officials on Tuesday as well as testimony before the House Appropriations Committee.
During his speech Dr Gottlieb did reiterate that, in FDA’s reading of federal law, CBD is not a legal dietary ingredient because it has previously been researched as a drug before promoters started bring CBD-containing supplements to the market. (Epidiolex, a CBD-based antispasmodic drug, was approved by FDA in 2018.)
But the FDA Commissioner also said the agency has the power to make special exceptions for certain ingredients.
“As such, for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing,” he said.
“We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD. But we know that this process could take time,” Gottlieb said. “So we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products,” Gottlieb said.
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Europe
Probi & Symrise explore probiotic ingredient uses for skin
Swedish probiotics firm Probi will collaborate with German fragrance and flavor giant Symrise on probiotic-based products that look to address sensitive and dry skin.
The aim is to combine the knowhow and expertise of Probi and Symrise to develop and launch a finished product by the end of this year.
Further terms of the deal will see this product manufactured in the US with Symrise owning the exclusive rights to sell the Lactobacillus plantarum HEAL19 strain to the worldwide cosmetics market.
The strain is expected to appear in a broad range of applications that include dry skin care, atopic prone skin care, baby care, sensitive skin care, body and face care.
“We are focusing our research on Lactobacilli, because they are present in our daily life as well as a part of the human microbiome,” said Imke Meyer, senior global product manager actives at Symrise.
“This specific strain was chosen out of a collection of Probi strains that were screened on specific skin health endpoints, as it combined quite a number of benefits in different in vitro and ex vivo studies.”
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Asia
Understanding null results in some omega-3-heart health studies
During a presentation during the inaugural NutraIngredients Omega-3 Summit, which took place in Singapore recently, Professor Trevor Mori, a research fellow at the University of Western Australia, explained that dietary intake, supplement dosage, and comorbidities are three factors that can be overlooked when trying to determine omega-3's effects on cardiovascular disease.
Referring specifically to EPA and DHA, Prof Mori said: “There are a number of studies that have looked at the benefits or potential benefits of omega-3 fatty acids on various aspects of cardiovascular disease.
“In a meta-analysis of over 170,000 patients with over 5,000 incident cases, there was about a 15% relative risk reduction with fish intake, and about 14% with omega-3 fatty acid intake.”
However, Prof Mori also said there was a need to consider trials that had produced less favorable outcomes.
“We need to look at a balanced argument here — not all RCTs have shown benefits of omega-3 fatty acids on cardiovascular disease.”
Indeed, one meta-analysis of 10 trials involving 77,917 individuals published in late 2018 in the journal JAMA Cardiology concluded that there was no significant association between omega-3 supplementation and coronary heart disease death.
“We have to ask ourselves why some of these studies, especially the more recent ones within the last 15 years, have failed to show any effect of omega-3 on heart disease.”
The likely reasons, he said, included the dosages used, the effect of background diet, and also the improvements in patient clinical care.
“It's really difficult to expect that omega-3 fatty acids can provide the same sort of benefits — over and above the clinical care patients are getting — compared to perhaps 20 to 25 years ago.”
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