Good New on NHPD Restrictions

Last week the NHPD released 10 natural source products back into the mainstream product application and use.

Only a few affect Herbalists, but this could be significant. All ten of these substances were restricted to prescription use only. The one that we are the happiest with are:

  1. Oil of Apiol,  Parsley oil
  2. Centella asiatica, Gotu Kola
  3. L- Tryptophan, amino acid
  4. Possibly Dimethyl Sulfoxide, DMSO

All of these four have been used in the Health food industry for years and came under restriction for various reasons. It has now been decided they can be used without prescription now. They could often be found in the ‘grey market’ from various destributors.

I have included the BEEP or you convenience.

From: BPRA_Message_BEEP <BPRA_Message_BEEP@hc-sc.gc.ca>
Subject: Changes to the Classification of Ten Naturally Sourced Ingredients – Changements à la classification de dix ingrédients d’origine naturelle
Date: 14 December, 2011 1:08:34 PM MST

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[Le texte français suit]

On December 7, 2011,  changes to the classification of ten naturally sourced ingredients were published in  the Canada Gazette, Part II.  These changes make them eligible for inclusion in natural health products. The following ten ingredients will no longer be restricted to prescription products only. They will become eligible, under certain conditions, for authorization under the Natural Health Products Regulations.

1. Oil of Apiol
2. Centella asiatica
3. Deanol and its salts
4. Theobromine and its salts
5. Dopamine and its salts
6. Gold and its salts
7. Uracil and its salts
8. Dimethyl Sulfoxide
9. Levocarnitine
10. L-Tryptophan 

Health Canada has reviewed evidence indicating that these medicinal ingredients are suitable for use without a prescription. For more information, please consult the Canada Gazette, Part II at http://www.gazette.gc.ca/rp-pr/p2/index-eng.html or contact Health Canada’s Natural Health Products Directorate at nhpd_dpsn@hc-sc.gc.ca.

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Le 7 décembre 2011, des changements à la classification de dix ingrédients d’origine naturelle ont été publiés dans la Partie II de la Gazette du Canada. Ces ingrédients pourront dorénavant entrer dans la composition de produits de santé naturels. L’utilisation des dix ingrédients qui suivent ne sera plus restreinte aux médicaments vendus sous ordonnance. Ces ingrédients pourront, sous certaines conditions, être autorisés en vertu du Règlement sur les produits de santé naturels.

1. Huile d’apiol
2. Centella asiatica
3. Déanol et ses sels
4. Théobromine et ses sels
5. Dopamine et ses sels
6. Or et ses sels
7. Uracile et ses sels
8. Diméthylsulfoxyde
9. Levocarnitine
10. L-Tryptophane 

Santé Canada a examiné des éléments de preuve indiquant que ces ingrédients médicamenteux peuvent être utilisés sans ordonnance. Pour obtenir de plus amples renseignements, veuillez consulter la Partie II de la Gazette du Canada à http://www.gazette.gc.ca/rp-pr/p2/index-fra.html ou communiquer avec la Direction des produits de santé naturels à nhpd_dpsn@hc-sc.gc.ca.


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