Dietary Supplements Amendment Regulations 2010

2010/5

Crest

Dietary Supplements Amendment Regulations 2010

Anand Satyanand, Governor-General

Order in Council

At Wellington this 1st day of February 2010

Present:
His Excellency the Governor-General in Council

Pursuant to section 42 of the Food Act 1981, His Excellency the Governor-General, acting on the advice and with the consent of the Executive Council, makes the following regulations.

Regulations

1 Title

  • These regulations are the Dietary Supplements Amendment Regulations 2010.

2 Commencement

  • These regulations come into force on 31 March 2010.

3 Principal regulations amended
4 Interpretation

  • (1) Regulation 2(1) is amended by revoking the definition of dietary supplement and substituting the following definition:

    “dietary supplement has the meaning given to it by regulation 2A”.

    (2) Regulation 2(1) is amended by revoking the definition of foodstuff.

    (3) The definition of incidental constituent in regulation 2(1) is amended by omitting “any food” and substituting “any dietary supplement”.

    (4) The definition of ingredient in regulation 2(1) is amended by omitting “including a food additive (other than an incidental constituent)” and substituting “other than an incidental constituent”.

5 New regulation 2A inserted

  • The following regulation is inserted after regulation 2:

    “2A Meaning of dietary supplement

    • “(1) In these regulations, dietary supplement means something to which subclauses (2) to (6) apply.

      “(2) It is an amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin.

      “(3) It is sold by itself or in a mixture.

      “(4) It is sold in a controlled dosage form as a liquid, powder, or tablet (which might be described on the label as a cachet, capsule, lozenge, or pastille instead of as a tablet).

      “(5) It is intended to be ingested orally.

      “(6) It is intended to supplement the amount of the amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin normally derived from food.”

6 Maximum daily doses

  • Regulation 3(1) is amended by omitting the item relating to folic acid and substituting the following item:

    Folic acid500 mcg in the case of a dietary supplement that the Director-General of Health has confirmed has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods
     300 mcg in the case of a dietary supplement that the Director-General of Health has not confirmed has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods

Michael Webster,
for Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations amend the Dietary Supplements Regulations 1985 in 2 ways. First, they provide a new definition of dietary supplement. The new definition confines a dietary supplement to a therapeutic-type product. This is because dietary supplements that are food-type products are covered by the New Zealand Food (Supplemented Food) Standard 2010. Second, the regulations provide for a 500 mcg maximum daily dose of folic acid in dietary supplements prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods.

The regulations come into force on 31 March 2010.

Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 4 February 2010.

These regulations are administered by the Ministry of Health.