Archer Daniels Midland (ADM) has said that it has received registration for its BeneFlax dietary supplement ingredient from the Canadian regulatory authority.
The flax lignan concentrate was accepted by Health Canada's Natural Health Products Directorate, which reviewed data in a Master File - including safety information - sent by ADM related to the ingredient.
The registration means that dietary supplement manufacturers in Canada can now seek approval for their products made with BeneFlax by referencing data provided in the BeneFlax Master File.
Flaxseed is one of the best sources of vegetarian omega-3 in the form of alpha linolenic acid, which has been studied for its role in heart, immune, and joint health, as well as for maintaining good skin. Flaxseed is one of the sources for dietary lignan, which has been linked to a reduced risk of a wide range of conditions, including breast and prostate cancers, as well as reduced hair loss.
SDG (Secoisolariciresinol Diglucoside) is the main lignan found in flax and is said to help maintain overall health including prostate, cardiovascular, colon and breast tissue health.
Beneflax has a 35 percent minimum concentration of SDG, which ADM claims this is the highest concentration presently available to supplement makers.
The Natural Health Products Directorate (NHPD), which is part of the Health Products and Food Branch of Health Canada, is the regulating authority for natural health products for sale in Canada.
It aims to ensure the safety, efficacy and quality of all natural health products sold in the country.
The registration of BeneFlax by the Natural Health Products Directorate means that it now has a reference number, which can be used by manufacturers to access data on the ingredient.
The US dietary supplement market for the ingredient opened up at the start of last year, when the US Food and Drug Administration (FDA) accepted ADM's new dietary ingredient (NDI) filing for Beneflax after it passed the 75-day notification period.
By regulation, new dietary ingredients must be notified to FDA 75 days prior to marketing. If the agency does not raise any objections to the new dietary ingredient within this 75-day period, the ingredients can be marketed in supplements.
Science and extraction
As a founder of the Flax Lignan Association with Acatris (now owned by Frutarom), since November 2005 ADM has been working to support the science behind standardized flax lignan ingredients and protect them from the risk to their credibility posed by unscrupulous suppliers.
Beneflax is made by means of a proprietary purification method, which ADM said maintains the flax lignans in their natural form as found in whole flax. The technology was developed by the Flax Consortium, a partnership between the Canadian government and university researchers, and is now under exclusive license to ADM.