The Natural and Non-prescription Health Products Directorate (NNHPD) is currently following up on a Notice to Impacted Stakeholders that was issued on September 22, 2016, requesting changes to the labels for all NHP doses of alpha-lipoic acid greater than or equal to 42 milligrams (mg) per day. Specifically, the NNHPD has requested that licence holders revise the risk information on their product licence application form and product labels. The following risk statement is now required:
• “If you experience sweating, paleness, chills, headache, dizziness and/or confusion, discontinue use and consult a healthcare practitioner (as these may be symptoms of serious low blood sugar)”.
To date, a number of responses have yet to be received from Health Canada regarding NHPs containing doses of alpha-lipoic acid greater than or equal to 42 mg per day. It is important to note that products that are found to pose a risk to health and/or are in violation of the Food and Drugs Act and related Regulations may be subject to compliance and enforcement actions in accordance with the Health Products and Food Branch’s (HPFB’s) Compliance and Enforcement Policy (POL – 0001). For further information relating to Compliance and Enforcement, please refer to the Natural Health Products Compliance and Enforcement guides and policies on the Health Canada website at:
Responses to this notice are requested to be provided to Health Canada no later than December 13, 2017. If no response is received, further regulatory actions may be taken as outlined in Sections 16-21 of the Natural Health Products Regulations.
Any further questions concerning this notice can be directed to the Risk Management Division by email at RMD_Communication_DGR@hc-sc.gc.ca