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Product Licensing and Health Canada Approval
Do you ever question which products are safe, approved by a regulatory body, and/or actually work the way they say they do?
Certain products are regulated, meaning that standards are set by regulatory bodies (such as the FDA and Health Canada) to ensure product safety and quality. Other products are assessed by qualified quality assurance personnel to guarantee consistent product quality and safety.
We have gathered this information all in one place so you can feel confident that we are doing our due diligence, and obtaining the proper licensing for qualified products.
What is an NPN:
Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops. All natural health products must have a product licence before they can be sold in Canada. Products with a licence have been assessed by Health Canada and found to be safe, effective and of high quality under their recommended conditions of use. You can identify licensed natural health products by looking for the eight-digit Natural Product Number (NPN) on the label.
Our alcohol based hand sanitizers and skeeter spray after-bite are considered Natural Health Products. We have several NPNs which can be found in the Licensed Natural Health Products Database (LNHPD). The NPN number does not restrict the package sizes and types, that is why all ACN sanitizing products with different counts have the same NPN number.
General NPN Lookup (hand sanitizers)
https://health-products.canada.ca/lnhpd-bdpsnh/index-eng.jsp
What is a DIN?
Our hard surface disinfectants and anti-bacterial soaps are considered drugs under the Canadian Food and Drugs Act and they must have an associated Drug Identification Number (or DIN). A Drug Identification Number (DIN) is a computer-generated, eight-digit number assigned by Health Canada to a drug product before being marketed in Canada. The DIN verifies that the product has been independently tested and proven to be an effective disinfectant. All products regulated in such a manner will have a ‘DIN’ number on the label.
General DIN lookup: (disinfectants and anti-bac soap)
https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
What is NDC?
The United States food and drug administration (FDA) also regulates many Canadian products which are sold in the US. The US regulates these products a little differently than Canada in that alcohol based hand sanitizers, hard surface disinfectants and anti-microbial hand washes are all considered drugs in the US. The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States. The 3 segments of the NDC identify: the labeler, the product, and the commercial package size.
- The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributer – Our facility number is 78806
- The second set of numbers is the product code, which identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific labeler.
- The third set is the package code, which identifies package sizes and types.
For example:
NDC for ACN 80% Sanitizing Wipes:
78806-101-xx(30/40/50 count...)
FDA Lookup (look up NDC here)
https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm
What is the EPA?
The U.S. Environmental Protection Agency (EPA) is an independent executive agency of the United States federal government tasked with human health and environmental protection matters. The EPA registers products that kill microorganisms on surfaces as pesticides. Before manufacturers can sell pesticides in the United States, the EPA must evaluate them thoroughly to ensure that they meet federal safety standards to protect human health and the environment. The EPA will grant a “registration” or license that permits a pesticide’s distribution, sale, and use only after the company meets the scientific and regulatory requirements.
EPA Establishment Registration – This is where you look up a specific establishment using the last part of the EPA registration number. (Our Establishment no. 98227or 98227-CAN-1)
https://www.epa.gov/compliance/national-list-active-epa-registered-foreign-and-domestic-pesticide-andor-device-producing
Where can the products be sold?
Products with NPN registration number or a DIN can be sold in Canada.
Products with NDC registration number can be sold in the U.S.
Our EPA products can be sold in both Canada and the US.
Why don’t the cleaning products have any of the above?
Because our traditional and original cleaning products that All Clean Natural still manufactures to this day do not claim to sanitize or disinfect, they are not a cosmetic or applied to the skin, and are not ingested - these products do not require any licenses or registration of any kind. They are, however, formulated with pure ingredients and monitored closely for quality and safety by our Quality and Compliance department. All of our products, including our cleaning products are made in our GMP compliant facility. Good manufacturing practices or (GMPs) are a set of universally accepted manufacturing standards which guarantee the consistent production of safe, high quality products.
Common links for references:
FDA drug facility registration lookup
https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
Sources:
https://www.drugs.com/ndc.html
https://en.wikipedia.org/wiki/Drug_Identification_Number
https://en.wikipedia.org/wiki/United_States_Environmental_Protection_Agency