A Richmond gummy vitamin and supplement company has stopped selling its natural health products in Canada after Health Canada cancelled its site licence last month.
A search on Health Canada's database shows Herbaland Naturals Inc.'s site licence for 13330 Maycrest Way in Richmond has been cancelled, while its licences for more than 300 natural health products are listed as suspended.
This site licence cancellation affects all Herbaland's natural health products with NPN product numbers that are sold in Canada, but not its many gummy products that are sold as snacks or exported to a variety of countries.
In a statement to the News, Health Canada confirmed Herbaland's product licences were suspended and site licence cancelled on March 28 because the company "was unable to meet the regulatory requirements of the Natural Health Products Regulations."
The requirements include good manufacturing practices to ensure health products are consistently made to meet Health Canada's safety and quality standards, explained Health Canada spokesperson Joshua Coke.
"They include standards relating to cleanliness of the premises and equipment, sanitation programs, employee training, operating procedures, quality assurance, record-keeping, product labelling, quality and stability period (shelf life)," he added.
A Herbaland representative, Francesca Raleigh, told the Richmond News they are working with both Health Canada and the FDA to correct any deficiencies and establish new standards for natural health products.
Raleigh said Herbaland is "working around the clock" to improve packaging for its natural health products and address any identified deficiencies. She added Herbaland stopped the sale of its products "right away" as soon as Health Canada directed them to do so.
No recall has been issued for Herbaland's packaged products.
However, a selection of Herbaland's gummy products was also placed on the U.S. Food and Drug Administration's (FDA) import Red List.
According to the import alert published on March 22, the FDA found "various food products that appear to be adulterated because they contain filth." Herbaland explained this referred to some "botanical ingredients" found in some products.
A private customer had ordered products from Herbaland with their own ingredient list and when the FDA inspected it under a microscope, the botanical ingredients were found in it, Herbaland co-founder Aisha Yang told the News.
Back in November, Health Canada issued a recall notice warning of 61 Herbaland products sold in bulk across Canada that were inadequately labelled, failing to show dosing instructions, ingredient lists and safety warnings. In response to the notice, the company worked with Health Canada to remove all affected products.
'In the process of being relicenced,' says Herbaland
As a result of the site licence cancellation and product licence suspension, Herbaland is currently not selling any of its natural health products in Canada.
"We just wanted to re-affirm that there is nothing our customers or the general public should worry about when it comes to our products," said Raleigh.
She told the News the company is currently "in the process of being relicenced."
Herbaland is also working closely with government authorities such as Health Canada and the FDA to "establish scientifically-based standards, particularly concerning the challenges arising from the increased use of natural ingredients like botanical powders in the formulations."
"Working with both agencies, we have not been requested to recall our packaged products and have stopped the sale of our supplements in Canada as we work to improve our packaging and formulation with the goal of bringing our vitamins back as soon as possible," she explained.
Raleigh added Herbaland hopes to resume product sales once Health Canada approves the packaging improvements.
"We have invited Health Canada to our facility to audit and we are working with them to bring our vitamins back as soon as possible," she said.
As for the FDA import alert, Raleigh said Herbaland is working with the FDA to "create a specific, science-based standards for gummy vitamin manufacturing," explaining that some organic and botanical ingredients used for Herbaland's U.S. private-label customers were "flagged by the FDA."
For now, Herbaland continues to export private-label products to the U.S. with approval from the FDA.
Applying for a new licence and getting off the Red List
To start selling products in Canada again, Herbaland will have to apply for a new site licence.
"The company would have to show that all the outstanding deficiencies have been addressed," said Coke.
Meanwhile, to remove its products from the FDA's Red List, Herbaland needs to "adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation," according to the import alert.
The process includes a minimum of five consecutive compliant commercial shipments offered for import and is meant to give the FDA confidence that future shipments will comply with regulations.
Last year, Herbaland co-founders Yang and Musharaf Syed were crowned Ernst & Young's (EY) Entrepreneur Of The Year in Canada. They are set to compete for the title of EY World Entrepreneur Of The Year in Monaco in June.
Health Canada's lists detailing site licence and natural health product licence statuses are available online.
- The original story has been corrected after clarifications were provided by Herbaland.
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