Regulatory News

Oleic acid CHD claims success: US FDA approves qualified claim petition on high level foods 

20 Nov 2018 --- The US Food and Drug Administration (FDA) has responded positively to a petition for a new qualified health claim for edible oils containing oleic acid. As a result, products with an oleic acid content upward of 70 percent, such as certain olive, canola and sunflower oils, can be labeled as carrying cardiovascular benefits, but only when replacing heart-damaging saturated fat.

Pesticide Testing: NSF International updates dietary supplement certification standard

14 Aug 2018 --- NSF International and the NSF/ANSI 173 Joint Committee have updated the pesticide testing requirements included in NSF/ANSI 173, the only American National Standard for dietary supplements. A recent NSF study established chemical-specific pesticide limits for 185 pesticides that might be present in botanical ingredients used in dietary supplement ingredients.

UK advertising watchdog backs “healthy” McDonald’s Happy Meals ad

08 Aug 2018 --- The UK advertising watchdog has ruled that McDonald’s Happy Meals can be advertised during children’s TV shows because they are “healthy.” But it banned ads for KFC and Kellogg’s Coco Pops for promoting junk food to young people. The Advertising Standards Authority (ASA) dismissed a complaint that a Pokémon-themed Happy Meal ad, which featured products including Chicken McNuggets, should not have been allowed to run between episodes of Peppa Pig.

DSM pursues biotin patent suit against China’s Anhui Tiger

07 Aug 2018 --- DSM is pursuing a patent infringement lawsuit in China against a competitor for what it calls the “misappropriation of intellectual property” pertaining to the production of a key ingredient of Biotin (also known as Vitamin B7 or Vitamin H). On August 2, 2018, DSM IP Assets BV and two related operating group companies, DSM Vitamins (Shanghai) Ltd. and DSM Vitamins Trading (Shanghai) Ltd. served a suit against Anhui Tiger in China for patent infringement.

EFSA greenlights novel foods status for Biova’s egg membrane hydrolysate, amid joint health surge

06 Aug 2018 --- The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) has recognized egg membrane hydrolysate BiovaFlex as novel food pursuant to Regulation (EU) 2015/2283. According to the applicant, Biova LLC (the supplier of BiovaFlex), the ingredient holds particular market potential due to its natural sourcing credentials as well as the convenience it brings by being water-soluble.

Essential support: Resource center issues guidance for Indian supplement firms as new regulations come into effect

02 Aug 2018 --- Two new guides have been published in India to help the country’s health supplement industry adapt to recently implemented regulatory requirements. Produced by the Resource Centre for Health Supplements and Nutraceuticals (ReCHaN), their publication is significant because they aim to function as a key stepping stone towards ensuring consistency of practice across India’s supplement industry and will assist in the application of relevant legislation governing the sector.

US-China trade policies threaten to bite botanicals industry

16 Jul 2018 --- Concerns are being raised that botanicals will be caught in the crossfire of the escalating US-China trade dispute as the Trump Administration’s second list of proposed tariffs targets key ingredients to the food and dietary sector. BI Nutraceuticals President and CEO George Pontiakos, is warning that the latest US government proposal for an additional 10 percent duty on US$200 billion worth of Chinese imports, could adversely affect “a vast range of industries including our own.”

Health claim victory: EFSA confirms physical performance benefits of carbohydrate solutions

14 Mar 2018 --- The European Food Safety Authority (EFSA) has published a scientific assessment confirming the beneficial health effects of glycemic carbohydrates on the improvement of physical performance during high-intensity and long-lasting physical exercise. As a result, sports nutrition companies will be able to include on-pack claims regarding the performance boosting capacity of products containing carbohydrate solutions (CHO).

US FDA Nutrition Facts label guidance prompts calls for earlier implementation date

02 Mar 2018 --- The commissioner of the US Food and Drug Administration (FDA), Dr. Scott Gottlieb, has issued new guidance on the proposed Nutrition Facts label to help food manufacturers to make the necessary changes by the upcoming compliance dates. In addition, Gottlieb unveiled plans to launch “a major educational campaign for consumers” regarding the revised labels. However, the Center of Science in the Public Interest (CSPI) has noted that with the guidance, an earlier compliance date for all companies for the updated Nutrition Facts label is both “realistic and achievable.”

Non-compliant supplements: Majority of online retailers fall foul of EU regulations

26 Feb 2018 --- A majority of online traders recently surveyed by the European Commission are offering novel foods and food supplements that clearly do not comply with EU regulations. This is according to the results of the first coordinated official controls of Internet marketed foods carried out by 25 EU Member States, Switzerland and Norway. Nearly 1,100 websites were checked for certain products which are non-compliant with EU food legislation. More specifically, the investigation mainly focused on four non-authorized novel foods and food supplements bearing medicinal claims, namely Agmatine (4 aminobutyl) guanidine sulfate, Acacia rigidula, Epimedium grandiflorum and Hoodia gordonii.

EFSA rejects Unilever black tea health claim

18 Jan 2018 --- The European Food and Safety Authority (EFSA) has rejected a health claim regarding black tea’s effects on the maintenance of normal endothelium-dependent vasodilation in adults. The application, submitted for authorization of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 by Unilever, pertained to “black tea beverages, either freshly prepared or reconstituted from water extract powders of black tea, characterized by the content of flavanols (expressed as catechins plus theaflavins) of at least 30 mg per 200 ml serving.”

Dutch doctors call for energy drinks ban for under 18s, Negative health effects reported in Canadian youth

16 Jan 2018 --- Calls for a ban on the sale of energy drinks to under 18s have intensified in the Netherlands. Pediatricians are once again arguing for a ban on the sale of energy drinks to young people under the age of eighteen. The Dutch Society for Pediatrics says it is treating more and more young patients who report with symptoms such as restlessness, fatigue and cardiac arrhythmia. A ban is highly unlikely, however, with the Dutch Ministry of Health responding dismissively to the calls.

EFSA more than doubles safe levels for 3-MCPD in vegetable oils and food

15 Jan 2018 --- The European Food Safety Authority (EFSA) has increased safe levels of the food processing contaminant 3-MCPD by two and a half fold, from the 2016 Tolerable Daily Intake (TDI) of 0.8 micrograms per kilogram of body weight to 2.0. The revision comes after EFSA experts used an updated scientific approach to reassess the possible long-term adverse effects of 3-MCPD on the kidney and male fertility.

Nutrition industry “feels positive” about new EU rules for novel foods: survey

19 Dec 2017 --- According to research by the organizers of Vitafoods Europe, many people working in the nutrition industry feel positive about the EU’s new process for the approval of novel foods. However, experts are warning that there could be adverse implications for some companies’ intellectual property portfolios. The new regulations on novel foods, defined as anything without a significant history of consumption in the EU before 15 May 1997, come into force on 1 January 2018. For the first time, the approval system will be centralized, with applications submitted to the European Commission rather than individual member states.

Synthetic antioxidant l-ergothioneine safe as a novel food for pregnant women and children: EFSA

24 Nov 2017 --- The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) has concluded that synthetic l-ergothioneine is safe under the proposed uses and use levels for the groups of the population which had been excluded by the applicant in the original application. Following a request from the European Commission, EFSA confirmed the safety of the powerful antioxidant for groups including infants, young children (i.e. toddlers), pregnant women and breastfeeding women.

Roadmap: Researchers publish recommendations for successful EU health food claims

14 Nov 2017 --- Researchers have developed recommendations to help food companies successfully substantiate new health claims in the EU. During this study, published in the highly regarded Trends in Food Science & Technology, researchers from the University of Surrey worked with investigators in Slovenia and Denmark as part of the REDICLAIM project. Together, they clarified the process of attaining approval for new health claims on food products.

Some infant rice cereals contain elevated methylmercury levels, study finds

26 Oct 2017 --- Eating large amounts of certain fish can expose consumers to methylmercury, which can potentially cause health problems. But recent research has shown that rice grown in polluted conditions can also have raised levels. A study appearing in the Americal Chemical Society’s (ACS) Journal of Agricultural and Food Chemistry reports that some types of infant rice cereal could also contain amounts of methylmercury that could potentially pose a health risk.

ID Nutra’s satiety product gets EFSA novel food nod

28 Sep 2017 --- The thirst and hunger suppressing specimen H. parviflora, marketed by ID Nutra as SatiPlus, has been approved as a novel food by the European Food Safety Authority (EFSA). The product’s potential benefits include a host of advantages related to weight loss and metabolism.

SNAP judgment says US nutrition assistance program falls short of providing healthy diet for all

11 Sep 2017 --- The Supplemental Nutrition Assistance Program (SNAP), formerly known as Food Stamps, only covers 43 to 60 percent of what it costs to consume a diet consistent with the US Department of Agriculture (USDA) MyPlate guidelines for what constitutes a healthy diet. This is according to a new study from North Carolina State University (NC State) and the Union of Concerned Scientists, which lays out in stark terms the challenges lower-income households face in trying to eat a healthy diet.

Benefits of early introduction of peanuts to infants recognized as health claim by US FDA

11 Sep 2017 --- The US Food and Drug Administration (FDA) has made a statement on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce the risk of peanut allergy. It has responded to a petition for a new claim that states, “for most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age.”

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