Herbaland Naturals Inc. Canadian Site License Cancelled and U.S. FDA Import Alert


Posted April 5, 2024 by HappyLife

Herbaland Naturals Inc., a Canadian gummy contract gummy manufacturer, has its site license revoked and is currently under a Red List U.S. FDA Import Alert as it's products are banned from sale in Canada and imports into the U.S. are detained.

 
Following a recall by Health Canada in November 2023 for Herbaland gummies due to inadequate labelling, Health Canada has further cancelled Herbaland Naturals' site license (#301288) due to serious health violations and dangerous findings during a recent audit of its facility and after third-party testing of its products.

Following suspicious findings in its in-house documentation as requested by Health Canada, Herbaland Naturals' products were ordered to undergo third-party testing and it's site license was suspended following test results. Third-party tests conducted on Herbaland Naturals' products found traces of filth (including but not limited to insect, rodent, other animal filth, and/or mold, (i.e., visually moldy product or microscopic count of mold hyphae also known as Howard Mold Count (HMC) method). These findings coupled with failed heavy metals tests led to the cancellation of Herbaland Naturals' site license.

Following its site license suspension, the U.S. FDA placed all Herbaland Naturals' products and any products produced for third-parties on Red List of the Import Alert. Import alerts inform the FDA's field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA's laws and regulation.

As of April 3, 2024, Herbaland Naturals' Canadian site license (#301288) has been cancelled by Health Canada. The company is unable to utilize this manufacturing site for the purposes of gummy manufacturing and packaging.

As of April 3, 2024, all of Herbaland Naturals' NPNs have been suspended, and the company is unable to distribute, manufacture, or market these products for sale in Canada.

As of April 4, 2024, Herbaland has not yet issued a recall on its products sold in Canada, the United States, or worldwide where its products are sold.

For more information regarding Herbaland Naturals' site license status, please visit https://nhpols-slpsn.hc-sc.gc.ca/slp-pls/

For more information regarding Herbaland Naturals' NPN status', please visit https://health-products.canada.ca/lnhpd-bdpsnh/?lang=eng

For more information regarding the U.S. FDA's Import Alert on Herbaland Naturals' products, please visit https://www.accessdata.fda.gov/cms_ia/importalert_1175.html
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Contact Email [email protected]
Issued By Musharaf Syed
Phone (604) 284-5050
Business Address 12340 Horseshoe Way, Richmond, BC V7A 4Z1
Country Canada
Categories Business , Consumer , Food
Tags herbaland , gummies , manufacturing , herbaland naturals , gummy vitamins
Last Updated April 5, 2024