Across the Nutra-verse: FDA’s CBD activity, Nestlé Health Science collaborates on microbiome supplements, and more

USA​

FDA’s attempts to put the brakes on CBD​

It was a busy start to the Thanksgiving week in the US for the FDA, which stated that it cannot conclude that CBD (cannabidiol) is generally recognized as safe (GRAS), stating “the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food”.​

Loren Israelsen, President of the United Natural Products Alliance (UNPA), said that the Agency seems to be closing off the GRAS affirmation pathway by noting in several of the warning letters that CBD in foods would require a food additive petition. “This is significant,”​ he said.

The Agency also revised its consumer update about CBD to outline specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood.

The update also noted that data from animal studies show that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males.

FDA also sent warning letters to 15 companies for selling various products containing CBD: 11 letters refer to products labeled as dietary supplements (for complete list, please scroll down to the end of this article).

UNPA’s Israelsen commented that the revised Consumer Update and warning letters are a significant, concerted and highly orchestrated effort by FDA to put the brakes on the CBD market.

For more on this, please click HERE​​.

Europe​

Nestlé Health Science and Caelus Health sign global agreement for microbiome supplements​

Nestlé Health Science has entered into a strategic collaboration with Dutch microbiome specialist Caelus Health to develop and ultimately commercialize microbiome-based food supplements.

The agreement provides Caelus with funding to pursue preclinical and clinical development of its lead microbiome-based products for the prevention, early treatment and management of cardio-metabolic diseases. Another aim is to eventually commercialize dietary supplements based on specific microbiota for the purpose of early intervention and nutritional management of diabetes and certain liver disorders.

Caelus’ platform uses the potential of Fecal Microbiota Transplant (FMT) studies as a discovery tool in cardio-metabolic diseases, and has resulted in a pipeline of intestinal microorganisms proprietary to Caelus, including Eubacterium hallii​ (E. hallii​).

“We are thrilled to announce this agreement which allows Caelus to advance its lead products in further development on a fast track to the global launch of food supplements targeting cardio metabolic disorders,”​ commented Luc Sterkman MD, CEO of Caelus.

For more on this story, please click HERE​​.

Asia​

NZ government proposes mandatory folic acid fortification of staples ​

The government of New Zealand is proposing to fortify wheat flour with folic acid to reduce the incidence of neural tube defects (NTDs), including spina bifida, in newborns.

The Ministry for Primary Industries (MPI) is proposing mandatory fortification of non-organic bread, bread-making wheat flour, or all wheat flour.

New Zealand currently has a voluntary stance on fortification, with the goal of fortifying 50% (by volume) of packaged sliced bread. As of 2017, the volume fortified was 38%. The country is considering keeping fortification voluntary but raise fortification rates to 80% of packaged sliced bread.

The new proposals were spurred by findings that between 2011 and 2015, the rate of NTD-affected pregnancies was 10.6 per 10,000 total births in New Zealand. This is higher than Australia (8.7), Canada (8.6), and the US (7).

Currently, 84 countries fortify industrially milled wheat flour, maize products and/or rice with folic acid, according to data from the Food Fortification Initiative (FFI)​. A meta-analysis​ published in 2010 showed an overall 46% reduction in neural tube defects such as spina bifida and anencephaly in countries where wheat flour was fortified with this B vitamin.

The US Centers for Disease Control and Prevention (CDC) has listed the prevention of neural tube defects through flour fortification amongst its list of 10 great health achievements​ in the US for the last decade.

For more on this, please click HERE​​.