Questions and Answers on Specific Criteria

November 2010

1. Why are products which meet the specific criteria (e.g., sterile natural health product (NHP) for ophthalmic use, for children under 12, etc.) considered to pose a risk to the health of a purchaser or consumer?
2. What about the other criteria in the current Compliance Policy for Natural Health Products (NHP)s?
3. My natural health product (NHP) is sterile but it is not ophthalmic. Does it qualify for the exemption?
4. My natural health product (NHP) is for adults only. Even though it is not targeted at pregnant or breastfeeding women, if pregnant or breastfeeding women may possibly use it, does that mean that I can't get an exemption number for the product?
5. The label of my natural health product (NHP) includes the following warning: "Do not use if pregnant or breastfeeding." Does this mean that I can't get an exemption for my product?
6. My natural health product (NHP) is for adults only. Even though it is not for children under 12, if they may possibly use it, does that mean that I can't get an exemption number for the product?
7. My product is intended for both adults and children. Is it eligible for an exemption number?
8. The label of my natural health product (NHP) includes the following warning: "Do not use in children under 12." Does this mean that I can't get an exemption for my product?
9. How will I know whether a stop sale or recall has been issued for an ingredient in my product?
10. What if my product contains an ingredient for which there was a stop sale and/or recall, but the stop sale and/or recall was lifted? Can I still get an exemption number for my product?
11. Can I revise my product to remove a Schedule A claim so that it doesn't meet the high risk criteria, and still get the exemption, or do I have to submit a completely new product licence application (PLA)?
12. Can I revise my product to remove a sub-population so that it doesn't meet the high risk criteria, and still get the exemption, or do I have to submit a completely new product licence application (PLA)?
13. What happens if a stop sale or recall is issued after my product has already received an exemption number?
14. Can I reformulate my product to remove an ingredient so that it doesn't meet the high risk criteria, and still get the exemption, or do I have to submit a completely new product licence application (PLA)?
15. What happens if I attest that my product does not meet the risk criteria, but then later it is determined that it does?

1. Why are products which meet the specific criteria (e.g., sterile natural health product (NHP) for ophthalmic use, for children under 12, etc.) considered to pose a risk to the health of a purchaser or consumer?

Due to the nature of these criteria the products may inherently pose a greater risk and as such require greater regulatory oversight.  A product meeting these criteria should not be available on the market until a full safety, efficacy and quality review is conducted.  These risk criteria were identified in the current Compliance Policy for NHPs as posing an unacceptable risk to health for unlicensed products and subject to compliance and enforcement actions.

2. What about the other criteria in the current Compliance Policy for Natural Health Products (NHP)?

The current Compliance Policy for NHPs also addresses products that are administered by puncturing the dermis, contain a prescription substance found on Schedule F to the Food and Drug Regulations (excluding homeopathic medicines), are contaminated, appear to be tampered with or are not labelled with adequate information to allow the product to be used safely. A product meeting one of these criteria (i.e., injectable, prescription substance) will be excluded from the NHPR if it does not meet the NHP definition.  Other violations may be related to issues that are not inherent to the product (contamination, tampering etc.). An NHP meeting these criteria are still considered to pose an unacceptable risk to health.

3. My natural health product (NHP) is sterile but it is not ophthalmic. Does it qualify for the exemption?

Yes, your product may qualify, unless other criteria are met (e.g., for a child under 12). Only products which are both sterile AND ophthalmic are ineligible for the exemption.

4. My natural health product (NHP) is for adults only. Even though it is not targeted at pregnant or breastfeeding women, if pregnant or breastfeeding women may possibly use it, does that mean that I can't get an exemption number for the product?

No. It is only when pregnant women are one of the target populations that you cannot get an exemption.

5. The label of my natural health product (NHP) includes the following warning: "Do not use if pregnant or breastfeeding." Does this mean that I can't get an exemption for my product?

No. It is only when pregnant women are one of the target populations that you cannot get an exemption.

6. My natural health product (NHP) is for adults only. Even though it is not for children under 12, if they may possibly use it, does that mean that I can't get an exemption number for the product?

No. It is only when children under 12 are one of the target populations that you cannot get an exemption.

7. My product is intended for both adults and children. Is it eligible for an exemption number?

No, it is not eligible for an exemption number since it includes children as one of the target populations. Products that are indicated for children under 12, which include sub-populations such as "children", "children (all ages)" and "all ages" do not qualify for the exemption.

8. The label of my natural health product (NHP) includes the following warning: "Do not use in children under 12." Does this mean that I can't get an exemption for my product?

No. It is only when children under 12 are one of the target populations that you cannot get an exemption.

9. How will I know whether a stop sale or recall has been issued for an ingredient in my product?

10. What if my product contains an ingredient for which there was a stop sale and/or recall, but the stop sale and/or recall was lifted? Can I still get an exemption number for my product?

No. A product licence must be obtained before the product can be sold.

11. Can I revise my product to remove a Schedule A claim so that it doesn't meet the high risk criteria, and still get the exemption, or do I have to submit a completely new product licence application (PLA)?

Yes, you can revise your product licence application to remove a Schedule A claim so that it doesn't meet the high risk criteria. Submitting a new PLA is not necessary. You must inform Health Canada of the changes you have made to your application.  Your product labels must also reflect the deletion of any Schedule A claims.

12. Can I revise my product to remove a sub-population so that it doesn't meet the high risk criteria, and still get the exemption, or do I have to submit a completely new product licence application (PLA)?

Yes, you can revise your product to remove a subpopulation so that it doesn't meet the high risk criteria. Submitting a new PLA is not necessary. You must inform Health Canada of the changes you have made to your application.  Your product labels must also reflect the deletion of the sub-population.

13. What happens if stop sale or recall is issued after my product has already received an exemption number?

The exemption number would be suspended. When an exemption number is suspended, the product could no longer be sold until a product licence is received. Although the exemption number would be suspended, the product licence application would continue to be assessed. A new PLA would not need to be filed.

14. Can I reformulate my product to remove an ingredient so that it doesn't meet the high risk criteria, and still get the exemption, or do I have to submit a completely new product licence application (PLA)?

Yes, you can reformulate your product to remove an ingredient so that it doesn't meet the high risk criteria. Submitting a new PLA is not necessary. You must inform Health Canada of the changes you have made to your application. Your product labels must also reflect the new ingredient information.

15. What happens if I attest that my product does not meet the risk criteria, but then later it is determined that it does?

The exemption number would be suspended. When an exemption number is suspended, the product could no longer be sold until a product licence is received. Although the exemption number would be suspended, the product licence application would continue to be assessed. However, a new PLA would not need to be filed - the existing PLA will still be assessed.