Weekly Roundup: GSK initiates new healthcare company spinoff, AHPA requests changes to USDA’s final rule on domestic hemp production

07 Feb 2020 --- In nutrition news this week, GlaxoSmithKline (GSK) initiated the spinoff of Consumer Healthcare into a new company. The American Herbal Products Association (AHPA) laid out significant changes to the US Department of Agriculture (USDA) Agricultural Marketing Service (AMS)’s Interim Final Rule (IFR) on domestic hemp production. Meanwhile, the US Food and Drug Administration (FDA)’s Small Entity Compliance Guide is set to further help small businesses with adhering to the 2020 nutritional labeling requirements. In the same week, ChromaDex launched a new line of cannabinoid (CBD) reference standards and NextFerm and Soft Gel Technologies released a line of ready-to-use Astagerm soft gel astaxanthin applications.

In brief: Business
GSK is currently preparing for a major split into becoming a biopharma company called New GSK with an immune system-focused approach, and a separate Consumer Healthcare company. The UK company officially started a two-year journey toward that split, which may take prescription dermatology along with it, having spun off its consumer health joint venture with Pfizer. Additional one-time costs to prepare Consumer Healthcare for separation are estimated at £600-700 million (US$776-905 million). Moreover, GSK released its fiscal year 2019 results, presenting “good performance with sales and earnings, together with strong cash generation,” GSK’s CEO Emma Walmsley says. The research company plans to continue strengthening its R&D pipeline from 2019. 

GSK released its 2019 fiscal year results. Source: GSK.The AHPA requested several significant revisions to the IFR that establishes a domestic hemp production program before a Final Rule is promulgated in 2021. The AMS indicated the IFR will be in effect for two years, impacting hemp production during the 2020-2021 hemp growing seasons. “The issuance of federal regulations for hemp production in the form of the IFR represents an important step forward for this crop. AHPA also believes that there exists significant room for improvement in the IFR and the subsequent Final Rule,” says AHPA Director of Program Development Jane Wilson.

In brief: Regulation
The FDA published an easily accessible and understandable Small Entity Compliance Guide (SECG) to help small businesses and packaged food manufacturers meet federal standards in the final rule “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” The 2016 final rule amends the labeling regulations for foods and dietary supplements to provide updated nutrition information on the label to help consumers maintain healthy dietary practices. The guide provides answers to questions regarding who is subject to the rule, how to comply with recordkeeping requirements and how nutrient values have been updated. At the beginning of 2020, the FDA made compliance with the updated Nutrition Facts labeling regulations mandatory for manufacturers with US$10 million in annual food sales, while manufacturers with less than that amount received an additional year to comply. 

Natural ingredients company Nexira continues its scientific studies recognize acacia gum as a dietary fiber in the US Nutrition Facts Labeling regulation. This follows the FDA’s conclusion last month that the body of evidence brought by acacia gum manufacturers is not yet sufficient and seeks further evidence to support the dietary fiber status of acacia gum. Nexira will continue to collaborate with the FDA and with the acacia gum industry to bring new data in 2020. This move adds to acacia gum’s continued usage as an approved Generally Recognized As Safe (GRAS) food additive.

In brief: Launches
ChromaDex launched a line of CBD reference standards, designed for laboratory use only, not for human consumption. This launch arrives as an expansion of its reference standards business, which are used as benchmarks to confirm the identity and potency of products. “In the CBD space, we see an abundance of misinformation and a shortage of quality standards testing. ChromaDex has been a leader in standards testing for over 20 years and we look forward to helping bring some scientific integrity to those interested in CBD,” says Rob Fried, ChromaDex CEO and Member of the Board of Directors of the Council for Responsible Nutrition.

SlimBiome is touted as assisting with weight management and feelings of satiety.Israel-based NextFerm and US company Soft Gel Technologies together released a new, exclusive-grade Astagerm astaxanthin, offered as ready-to-use soft gels. The companies also announced the launch of a special grade for gummies and the patenting of this product. “For us, we see a great opportunity to introduce a new and fresh approach to what was a completely generic and stagnant market until recently. Astaferm is a non-GMO, sustainable and non-marine-sourced astaxanthin. This is a natural and effective product, which offers brands a simple way to differentiate themselves at a competitive price and without compromising on the highest quality standards,” says Steve Holtby, President and CEO of Soft Gel Technologies.

Agropur and OptiBiotix partnered to introduce SlimBiome, a blend of non-digestible prebiotics, to the North American market. Its dietary fibers have been clinically proven to create a longer-lasting feeling of fullness, enhanced metabolism and help control food cravings. OptiBiotix Health selected Agropur to be the exclusive distribution partner of SlimBiome in the US. The relationship of these two companies is set to make a splash in the US weight management market – estimated to be worth US$72 billion in 2019, the company states. SlimBiome is heat stable in processing; includes a short, vegan ingredient list that taps into the naturality trend and offers a neutral flavor profile. Besides sports nutrition applications, SlimBiome is suitable for food and beverages, dairy and dietary supplements. 

In brief: Research
Sucralose consumption may affect blood glucose and insulin levels on glucose tolerance tests, scientists from the University of Illinois found in a new study. Despite having no calories, sucralose may have metabolic effects in some users. When the test subjects of healthy weight swallowed the sucralose, their blood insulin levels decreased modestly during the first hour and their insulin sensitivity increased by about 50 percent. Meanwhile, when obese people swallowed the sucralose, their insulin levels increased significantly more than when they drank water or when they tasted the sucralose but spat it out. 

Twelve weeks supplementation of EVNol SupraBio, produced by ExcelVite, significantly improved renal function in diabetic nephropathy patients, as demonstrated in a study published in Therapeutic Advances in Endocrinology and Metabolism. Diabetic nephropathy (DN), also known as diabetic kidney disease, is one of the major complications of diabetes. The study authors were surprised to see that patients supplementing with EVNol SupraBio, a self-emulsifying palm tocotrienol complex, still had a stable renal function for six to nine months after ending supplementation. This “legacy effect,” the study touts, is of utmost interest in that the tocotrienols’ effect persisted for more than six months, and EVNol SupraBio may be an adjunct to standard diabetic therapy to delay the progression of diabetic nephropathy.

In brief: Miscellaneous
The European Specialist Sports Nutrition Alliance (ESSNA) has welcomed its newest member, Guernsey-based sports nutrition retailer Healthspan Elite. With over 50 existing member companies across Europe, the ESSNA serves as a discussion forum and vehicle for action for the sports nutrition sector. “We hope that being part of ESSNA will assure our customers and partners of our commitment to maintaining the highest standards in everything we do. We look forward to the added industry insight and governance that ESSNA provides,” says Chris Fisher, Head of Healthspan Elite.

By Anni Schleicher