Regulatory News

TSI’s manufacturing license for HMB approved in China

21 Aug 2017 --- TSI Group (TSI) has announced the approval of the first and only CFDA (China Food and Drug Administration) Manufacturing License for beta-hydroxy-beta-methylbutyrate (HMB) production in China. TSI’s Jiangyin Pharmaceutical facility, a wholly owned TSI Group company, received this exclusive license to produce HMB for use in Chinese food products.

Cutting calories now “critical” to UK childhood obesity strategy

18 Aug 2017 --- The health agency Public Health England (PHE) has shifted its focus away from solely targeting sugar to cutting excess calorie consumption from all sources in its anti-obesity strategy for children in the UK. “A third of children leave primary school overweight or obese and an excess of calories – not just excess sugar consumption – is the root cause of this,” says Duncan Selbie, Chief Executive of PHE. “We will work with the food companies and retailers to tackle this as the next critical step in combating our childhood obesity problem.”

US FDA grants clearance for the use of Verdeca’s HB4 stress-tolerant soybeans in human food

11 Aug 2017 --- Arcadia Biosciences Inc. and Bioceres S.A. have announced that the US Food and Drug Administration (FDA) has completed its full review of the safety evaluation for HB4 soybeans, produced by their joint venture, Verdeca. The FDA’s notice to Verdeca allows products derived from HB4 soybeans to be used commercially in human food and animal feed. 

Report notes 50 percent increase in calls to US poison control centers over supplement use

11 Aug 2017 --- A study into dietary supplement exposures in the US has found that there was an overall 50 percent increase in the rate of calls to poison control centers about exposure to dietary supplements from 2000 through 2012. Most of the exposures were found to occur in children younger than 6 years old, raising concerns about the safety of keeping certain dietary supplements around children.

EFSA updates dietary reference values for riboflavin

08 Aug 2017 --- The European Food Safety Authority (EFSA) has set updated dietary reference numbers for riboflavin (vitamin B2) as part of its review of scientific advice on nutrient intakes. The research, requested by the European Commission and published in the EFSA Journal on 7 August, updates population reference intakes (PRIs) for adults, children and pregnant and lactating women.

Cargill’s erythritol dental health claim rejected by EFSA

27 Jul 2017 --- Cargill cannot prove its EU Article 14 claim submission [disease risk reduction claim] that there is a cause-and-effect relationship between sugar-free hard confectionery with at least 90 percent erythritol and the reduction of dental plaque, according to the European Food Safety Authority (EFSA).

US: Should federal health agencies accept funding from big soda?

26 Jul 2017 --- Newly appointed director of the Centers for Disease Control and Prevention (CDC), Dr. Brenda Fitzgerald, is in the spotlight as one of the key US health officials recently hired by the Trump administration. Why? Because when she was the health commissioner for Georgia – which has one of the highest rates of childhood obesity in the US – she accepted funding from Coca-Cola to run an exercise program designed to get children to lose weight.

EU presidency discussions consider policy for alcohol labeling

26 July 2017 --- Estonia intends to address cross-border alcohol policy issues, including the labeling of alcoholic beverages, as one of the priorities of its presidency of the EU. The labeling issue is an important part of its goal to reduce alcohol-related harm in Europe, according to World Health Organization (WHO) Europe.

FSA sets out plans for food regulation to meet modern market needs

21 Jul 2017 --- The Food Standards Agency (FSA) in the UK has published the department's plans to change food regulation in England, Wales and Northern Ireland, particularly in the post-Brexit UK. Its plans include taking the burden of regulation off businesses that do the right thing for consumers and adjusting to the modern food marketplace.

EFSA Maintains 1993 Dietary Reference Values for Vitamin K

23 May 2017 --- The European Food Safety Authority (EFSA) has decided to maintain the dietary reference values (DRVs) for vitamin K set in 1993. During a 6-week public consultation launched earlier this year to collect feedback from the scientific community and any interested parties on the draft Scientific Opinion on DRVs for vitamin K, EFSA received 43 different submissions with comments from 10 interested parties. After reviewing and addressing these comments, it decided to maintain the 1993 DRVs.

EFSA Publishes New Guidance on Infant Formula from Protein Hydrolysates

12 May 2017 --- New guidance published by EFSA will assist applicants in preparing and presenting dossiers for authorisation of infant and/or follow-on formulae manufactured from protein hydrolysates. It will also help applicants in preparing dossiers to assess a product’s efficacy in reducing the risk of infants becoming allergic to milk proteins. 

USDA Proclamation on School Meals Garners Criticism from Lobby Group

02 May 2017 --- The US Secretary of Agriculture Sonny Purdue has signed a proclamation that will allow schools to begin “the process of restoring local control of guidelines on whole grains, sodium and milk” and give them greater flexibility in meeting regulations for school meals. Although Patricia Montague, CEO of the School Nutrition Association, praised the proclamation, it received criticism from CSPI Nutrition Policy Director Margo G. Wootan, who says that the new secretary has started to “roll back progress on the quality of the meals served to America’s children.”

New EU Medical Devices Regulation to Hit Nutritional Sector Claims

06 Apr 2017 --- The Council of the European Union has adopted a final version of the new Medical Device Regulation (MDR) which will handle substance-based medical devices more strictly. Consequently, substance-based medical devices will no longer be classified as class I, but will be classified as at least class II-a or II-b. 

EU Health Claim Regulations Complex But Navigable

03 Apr 2017 --- EU regulations on health claims on food are complex but navigable, a study into food regulations has found. The study, led by Professor Monique Raats at the University of Surrey, working with researchers from Slovenia and Denmark, found that EU regulation, which is aimed at substantiating marketing claims of the health benefits of food, has presented barriers for manufacturers wanting to show the health benefits of their products based on detailed scientific research.

DSM Achieves IFOS Certification For Its Meg-3 Line Of Fish Oil

15 Feb 2017 --- The International Fish Oil Standards (IFOS) Program have announced that DSM, a leading player in the health products space worldwide, has achieved the IFOS certification for their MEG-3 and MEG-3 Ultra product lines of fish oil.  

NHS May Ban Sugary Drinks From Hospitals

09 Nov 2016 --- NHS England has announced details of proposed new action to cut obesity and reduce the sales and consumption of sugary drinks sold in hospitals.

Soda Companies Sponsor 96 Health Organizations in Five Years

11 Oct 2016 --- Two of the largest soda companies in the US sponsored at least 96 national health organizations from 2011 to 2015, according to a study from researchers at Boston University. The researchers say the sponsorship deals dampened the health groups' support of legislation to reduce soda consumption and impeding efforts to combat the obesity epidemic.

Vinpocetine is Not a Dietary Ingredient, Say FDA

07 Sep 2016 --- A Food and Drug Administration (FDA) notice has requested comments on it’s tentative conclusion that vinpocetine is not a dietary ingredient, and it’s subsequent exclusion from the definition of a dietary supplement.

FDA: CBD Warning Letters Cite Health Claims, Drug Applications

22 Feb 2016 --- The US Food and Drug Administration (FDA) has sent eight warning letters to manufacturers of cannabidiol (CBD) dietary supplement and food products, causing the debate over hemp CBD’s legal status to continue.
The warning letters cite prohibited health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration.

EFSA Opens Public Consultation for Vitamin B6 Dietary Reference Values

05 Feb 2016 --- The European Food and Safety Authority (EFSA) has launched an open consultation on its draft scientific opinion on dietary reference values (DRVs) for vitamin B6. This document proposes recommendations for adults, infants and children, pregnant and lactating women.