Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period (4 pages, in English)

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Distribution date: 25 March 2003

The Food and Drug Administration (FDA) is reopening the comment period for a proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids” that published in the Federal Register of 4 June 1997 (62 FR 30678) (the June 1997 proposal). In that document, FDA proposed a number of requirements relating to dietary supplements containing ephedrine alkaloids, including a requirement for a warning statement on the product label. Since publication of the June 1997 proposal, new scientific evidence has come to light concerning health risks associated with the use of dietary supplements containing ephedrine alkaloids. FDA is reopening the comment period to receive comment on this new evidence, as well as on the warning statement it is now considering for dietary supplements containing ephedrine alkaloids. FDA also intends to consider, to the extent possible, whether in light of current information FDA should determine that dietary supplements containing ephedrine alkaloids present a “significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.”

Products Covered: Dietary Supplements (ICS 71)

Regulation Type: Regular notification

Food standards

Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period (4 pages, in English)

Product Image

Distribution date: 25 March 2003

The Food and Drug Administration (FDA) is reopening the comment period for a proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids” that published in the Federal Register of 4 June 1997 (62 FR 30678) (the June 1997 proposal). In that document, FDA proposed a number of requirements relating to dietary supplements containing ephedrine alkaloids, including a requirement for a warning statement on the product label. Since publication of the June 1997 proposal, new scientific evidence has come to light concerning health risks associated with the use of dietary supplements containing ephedrine alkaloids. FDA is reopening the comment period to receive comment on this new evidence, as well as on the warning statement it is now considering for dietary supplements containing ephedrine alkaloids. FDA also intends to consider, to the extent possible, whether in light of current information FDA should determine that dietary supplements containing ephedrine alkaloids present a “significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.”

Products Covered: Dietary Supplements (ICS 71)

Regulation Type: Regular notification

Food standards

Interim Marketing Authorization regarding the use of Microcrystalline Cellulose in Whipping Cream (available in English and French; page 744)

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Distribution date: 20 March 2003

Provision currently exists in the Food and Drug Regulations for the use of microcrystalline cellulose as a stabilizing and thickening agent in a variety of foods. Health Canada has received a submission to permit the use of microcrystalline cellulose as a stabilizing and thickening agent at a maximum level of use of 0.2 per cent in whipping cream that has been heat-treated below 100°C. Evaluation of available data supports the effectiveness and safety of this new use for microcrystalline cellulose. Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the optional use of microcrystalline cellulose as a stabilizing and thickening agent at a maximum level of use of 0.2 per cent in the manufacture of whipping cream that has been heat-treated below 100°C. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of microcrystalline cellulose as indicated above while the regulatory process is undertaken to formally amend the Regulations. A revision to this notification will be published at the start of the amendment process and Members will be given the opportunity at that time to submit comments on this proposed measure.

Products Covered: Whipping cream (ICS: 67.100.10, 67.220.20)

Regulation Type: Regular notification

Food safety Human health Food additives

Interim Marketing Authorization regarding the use of Microcrystalline Cellulose in Whipping Cream (available in English and French; page 744)

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Distribution date: 20 March 2003

Provision currently exists in the Food and Drug Regulations for the use of microcrystalline cellulose as a stabilizing and thickening agent in a variety of foods. Health Canada has received a submission to permit the use of microcrystalline cellulose as a stabilizing and thickening agent at a maximum level of use of 0.2 per cent in whipping cream that has been heat-treated below 100°C. Evaluation of available data supports the effectiveness and safety of this new use for microcrystalline cellulose. Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the optional use of microcrystalline cellulose as a stabilizing and thickening agent at a maximum level of use of 0.2 per cent in the manufacture of whipping cream that has been heat-treated below 100°C. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of microcrystalline cellulose as indicated above while the regulatory process is undertaken to formally amend the Regulations. A revision to this notification will be published at the start of the amendment process and Members will be given the opportunity at that time to submit comments on this proposed measure.

Products Covered: Whipping cream (ICS: 67.100.10, 67.220.20)

Regulation Type: Regular notification

Food safety Human health Food additives

Dominican Standard NORDOM No. 422, Milk and Milk Products. Parmesan Cheese. Definition and Specifications (4 pages, in Spanish).

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Distribution date: 14 March 2003

Establecer los requisitos de la materia prima e ingredientes permitidos, además de los requisitos microbiológicos, organolépticos y físicoquímicos para la elaboración del queso picantino.

Products Covered: Harmonized System (HS) code 0406.90.30

Regulation Type: Regular notification

Food standards

Dominican Standard NORDOM No. 422, Milk and Milk Products. Parmesan Cheese. Definition and Specifications (4 pages, in Spanish).

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Distribution date: 14 March 2003

Establecer los requisitos de la materia prima e ingredientes permitidos, además de los requisitos microbiológicos, organolépticos y físicoquímicos para la elaboración del queso picantino.

Products Covered: Harmonized System (HS) code 0406.90.30

Regulation Type: Regular notification

Food standards

Dominican Standard NORDOM No. 439, Edible Oils and Fats. Edible Fats. Specifications (5 pages, in Spanish).

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Distribution date: 13 March 2003

Definiciones. Requisitos organolépticos. Requisitos microbiológicos. Requisitos químicos. Envase y rotulado.

Products Covered: Harmonized System (HS) Codes 1502.00.10, 1504.20, 1504.30, 1506.10.00; Edible fats; International Classification for Standards (ICS) code 67.200.10

Regulation Type: Regular notification

Food standards

Dominican Standard NORDOM No. 439, Edible Oils and Fats. Edible Fats. Specifications (5 pages, in Spanish).

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Distribution date: 13 March 2003

Definiciones. Requisitos organolépticos. Requisitos microbiológicos. Requisitos químicos. Envase y rotulado.

Products Covered: Harmonized System (HS) Codes 1502.00.10, 1504.20, 1504.30, 1506.10.00; Edible fats; International Classification for Standards (ICS) code 67.200.10

Regulation Type: Regular notification

Food standards

Dominican Standard NORDOM No. 269, Milk and Milk Products. Cheddar Cheese. Definitions and Specifications (5 pages, in Spanish).

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Distribution date: 13 March 2003

Establecer los requisitos físicoquímicos, microbiológicos y organolépticos para la elaboración del queso Cheddar.

Products Covered: Harmonized System (HS) Code 0406.90.20

Regulation Type: Regular notification

Food standards

Dominican Standard NORDOM No. 269, Milk and Milk Products. Cheddar Cheese. Definitions and Specifications (5 pages, in Spanish).

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Distribution date: 13 March 2003

Establecer los requisitos físicoquímicos, microbiológicos y organolépticos para la elaboración del queso Cheddar.

Products Covered: Harmonized System (HS) Code 0406.90.20

Regulation Type: Regular notification

Food standards

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