Health Canada urges safer gelatin for caps after BSE
replace what is frequently bovine-sourced gelatin, a decision that
coincides with a new case of "mad-cow disease" in the
country.
Among other purposes, gelatin is used for encapsulating or formulating dietary supplements and can be made from a variety of animal materials. But Health Canada is now narrowing the scope of various gelatins it approved for sale in the past, so as to further ensure no potentially disease-causing agents are used.
The announcement could spell even more business for companies that have diversified into vegetarian alternatives to gelatin, as supplement makers hunt for replacements to fulfill tightening regulations.
In its announcement yesterday, the National Health Products Directorate (NHPD) said it "strongly encourages" manufacturers to use materials know to be safe, including plant materials, gelatin from certain animal bones, skin or hide.
The NHPD, Health Canada's regulating authority for natural health products, says it will allow manufacturers to continue using gelatin made from cattle, sheep, goat, deer and elk bones. However, the bones must not include the skull or vertebral column of the animals and suppliers have to submit documentation demonstrating they use required quality control measures during manufacturing.
But the gelatin industry has previously said that fear surrounding the use of its product in encapsulation is unfounded.
"We have totally proven that there is no link between gelatin and BSE," Oliver Wols of European gelatin specialist The Gelita Group told NutraIngredients.com in January.
Bovine spongiform encephalopathy is a degenerative and fatal disease of the nervous system in cattle. The first confirmed case was found in 1986 in the United Kingdom, peaking to an epidemic 35,000 cases in 1992.
The health scare over Creutzfeldt-Jakob disease, a rare human variant of BSE, then spread to other nations. This human strain is thought to be the result of eating cattle tissues infected with the BSE agent.
The latest BSE case, confirmed Tuesday, is the sixth to hit Canada since 2003. The cow, found in the province of Manitoba, was born before 1997 - the year Canada began restricting potentially dangerous feed.
It could serve as further impetus for capsule and ingredients manufacturers to move away from gelatin if they want to avoid the intense federal scrutiny that involves disclosing which part of an animal has been used.
The NHPD is sending notices to current licensees (Canada requires pre-market approval for dietary supplements) and license applicants. The authority says products not able to prove their gelatin meets requirements will be "subject to compliance action".
Plant-based capsule makers are vying for a larger slice of the market. In the past two years, the size of the US vegetable capsule market has grown by 54 percent. The market for such softgels rose from $43.3m in 2004 to $66.6m in the year ending May 2006, according to natural products industry market researcher SPINS.
Capsugel, a division of pharmaceutical giant Pfizer, has been at the forefront of vegetarian capsule innovation, with an entire Mexican facility devoted to making plant fiber softgels.
The Canadian Food Inspection Agency (CFIA) is also confident its beef supply is safe.
"Based on the over 115,000 animals tested since Canada's first case in 2003, the CFIA is confident that the level of BSE in the national cattle herd is very low," the CFIA said in a written statement.
