Weekly Roundup: FDA introduces draft guidance for NDI, BioGaia to distribute probiotics in Canada under own management

20 May 2022 --- This week in nutrition news, the US Food and Drug Administration (FDA) made draft guidance available, with the goal of enhancing the amount of safety information the agency has regarding the dietary supplement market. Probiotic producer BioGaia will begin its own distribution in Canada in a move to increase B2C sales in 2023. Meanwhile, an initial American Herbal Products Association (AHPA) time study results predict a cost of roughly US$20 million for the Durbin/Braun product listing bill’s initial compliance.

In brief: Business news
Beneo acquired Meatless, a supplier of textured plant-based ingredients with a diverse array of products derived from various source materials – rice, faba beans, wheat, pea, lupin and quinoa. This range will complement Beneo’s ingredient portfolio, allowing for new combinations. As a result, Beneo’s customers will have access to a considerably wider range of products and more flexibility, allowing for the creation of meat and fish substitutes. Meatless’ products are pegged as environmentally friendly, with low carbon footprint manufacturing procedures, supporting Beneo’s aim of using manufacturing facilities to minimize total CO2 emissions.

Hyland’s Naturals is shifting its focus from offering consumer health products in the pediatric and general wellness categories to the women’s health and pet sectors. The company will now offer over 20 new natural wellness products this year to accommodate the growing need for natural and effective health products, in line with the needs of its customers and merchants.

The UL Verified Mark will appear on Walgreens brand vitamins and supplements.Retail business Walgreens achieved certifications company’s UL Verified Mark that will appear on Walgreens brand vitamins and supplements and improve ingredient transparency. The UL Verified Mark will appear on ingredients mentioned on the product’s nutritional or supplement information panel. Any Walgreens brand vitamin or supplement that UL has verified will display a UL Verified Mark with an identifier number that consumers can use to understand the verification methodology described on the publicly available UL Verify database to build trust and reinforce transparency.

BioGaia will begin selling probiotics in Canada under its management in 2023. Following the acquisition of Nutraceutics in the US at the end of 2021, BioGaia intends to capitalize on operational efficiencies. As a result, the company has agreed to terminate its current distributor, Ferring. The collaboration with Ferring began in 2012, and various BioGaia products have been launched in Canada since then. The decision is part of the company’s larger plan to boost B2C sales. In Canada, the regulatory environment for BioGaia’s probiotic products is favorable, allowing the business to communicate health benefits and claims.

Swiss biotech company, Evolva updated its progress on achieving its 2022 guidance. The company believes it will achieve its goal of 50% sales growth and a positive double-digit contribution margin this year. Two recently announced customer orders demonstrate a solid market momentum of over CHF 1 million (US$1.03 million). The immediate focus is on three levers: boosting commercial performance, profitability improvement, and culture goals.

In brief: Launches and releases
US-based Atmabala has unveiled ashwagandha as the new ingredient in its high-protein energy bar Btein Bars. The bars contain 20 g of protein and low-glycemic natural sugars in addition to ashwagandha. The Btein Bars are available in chocolate almond and coconut almond flavors. According to the company, the ashwagandha within the Btein Bars may alleviate stress and anxiety, relieve arthritis symptoms, improve exercise performance and improve sleep quality.

In brief: Regulatory developments
An AHPA study estimates that the dietary supplement industry will spend nearly US$20 million on initial compliance with the Dietary Supplement Listing Act, a bill introduced by Senators Richard Durbin and Mike Braun that would require mandatory product listing (MPL) for all dietary supplements sold in the US. This figure has surfaced as AHPA researched to determine how much time and money it would take to compile product listings by the bill’s requirements. This preliminary estimate only includes the expenses of product data input for first compliance; it excludes accompanying training costs or other year-over-year compliance costs. The AHPA is still gathering data from industry members to refine this estimate. The AHPA has opposed the Dietary Supplement Listing Act, believing that the existing regulatory framework for dietary supplements gives FDA all of the authority it needs to regulate the industry adequately.The critical ingredient in Btein Bars, a new high-protein energy bar, is ashwagandha.

The FDA’s draft guidance, if adopted, will advise the dietary supplement sector that the FDA plans to exercise enforcement discretion, for a limited time and in restricted circumstances, to encourage manufacturers and distributors to address any past failures to submit a mandatory NDI notification. The FDA can gather additional safety information about the dietary supplement sector and better protect public health by giving industry the opportunity to address past failures to submit needed safety information. The Council for Resposnible Nutrition’s president and CEO, Steve Mister supports the FDA’s move: “We encourage companies who have products in the market that are using clearly defined new ingredients to take advantage of this opportunity and submit to the agency their data demonstrating the safety of these products.”

The US Department of Agriculture’s secretary Tom Vilsack made a statement about his intention to nominate Stacy Dean for undersecretary for Food, Nutrition and Consumer Services (FNCS). “Since the start of the Biden-Harris Administration, Stacy Dean has been dedicated to advancing food and nutrition security for all US citizens as the deputy undersecretary of FNCS,” says Vilsack. Dean previously worked as a budget analyst for the office of management and budget before joining CBPP. At CBPP, she worked on policy creation, regulatory and legislative review and budgeting processes resulting in the implementation of income assistance programs.

By Nicole Kerr