Vitamin D Limits for NHPs are now Higher

Vitamin D Limits for NHPs are now Higher

The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was coined by the sunlight’s ability to provide levels of Vitamin D based on the level of exposure a person has. The most widely used form of Vitamin D is Cholecalciferol, which is predominately sourced from sheep’s wool otherwise known as lanolin making most Vitamin D sources non-vegan or vegetarian. 

Vitamin D is important in a large number of biological functions and processes such as helping with immune function and the development of bones and teeth as well as the absorption of calcium and phosphorus. Vitamin D is most commonly associated with international unit or IU value, however, the correct unit for the sunshine vitamin is micrograms (mcg).  Both the microgram and the IU value are listed on the product license for the Natural Product Number (NPN).  

Formerly, the highest dosage acceptable for natural health products (NHPs) was 1000 IU or 25 mcg daily. Daily doses above 25 mcg are considered prescription drugs and are on the prescription drug list.  Health Canada has since changed their decision on this. As of February 2021, the prescription drug list was amended to allow doses below 2500 IU or 62.5 mcg daily are permissible to be licensed as natural health products, values above this remain as prescription drugs. 

Fortunately, Health Canada has published a product monograph specifically for this high dose Vitamin D category.  The high dose monograph is exclusive to single ingredient products and restricts the use of such a high dose to six months without the advice of a health care practitioner or physician. Furthermore, only two claims can be made at such a high dose: 

  • Helps to prevent vitamin D deficiency
  • Vitamin D intake, when combined with sufficient calcium, a healthy diet and regular exercise may reduce the risk of developing osteoporosis in people with vitamin D deficiency

As there are many product monographs it may be difficult for one to easily identify which monographs are specific to Vitamin D. One of the easiest ways is to search Vitamin D within the natural health product ingredient database (NHPID). The entry is linked to the monographs and only displays the applicable ones. Additionally, the entry details the restrictions around the non- NHP eligibility such as below: 

  • A non-NHP because listed in the Prescription Drug List as follows: Vitamin D, in oral dosage form containing more than 62.5 µg or 2,500 International Units of Vitamin D per dosage form, or where the largest recommended daily dosage shown on the label would result in the daily intake by that person of more than 62.5 µg or 2,500 International Units of Vitamin D.

As this change in regulation is recent, there is a large opportunity to tap into this untouched market. Our Experts at Quality Smart Solutions can offer support to your needs for foods, cosmetics, OTC drugs and medical devices for North America.

How We Can Help

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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Source:

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=multi_vitmin_suppl&lang=eng

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=vitamin.d.hd&lang=eng

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq.do?id=2935&lang=eng

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list.html

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