Regulatory Updates

Distribution date: 16 April 2003

Products Covered: Certain dangerous materials and preparations: VI. (Chemical materials) /2801-3824/

Regulation Type: Regular notification

Distribution date: 16 April 2003

Products Covered: Certain dangerous materials and preparations:  VI. (Chemical materials) /2801-3824/

Regulation Type: Regular notification

Distribution date: 16 April 2003

Products Covered: Certain dangerous materials and preparations:  VI. (Chemical materials) /2801-3824/

Regulation Type: Regular notification

Distribution date: 11 April 2003

Products Covered: Sanitizing Products (HS: 34.01, 34.02)

Regulation Type: Regular notification

Distribution date: 11 April 2003

Products Covered: Sanitizing Products (HS: 34.01, 34.02)

Regulation Type: Regular notification

Distribution date: 11 April 2003

National minimum and maximum limits for vitamins and minerals in food supplements per daily dose of product as recommended according to labelling, cf. attachment. The notified vitamins and minerals are Vitamin A, Vitamin D, Vitamin E, Vitamin K, Tiamin, Riboflavin, Niacin, Folic acid, Vitamin B6, Pantothenic acid, Vitamin B12, Biotin, Vitamin C, Calcium, Phosphorus, Magnesium, Iron, Copper, Iodine, Zinc, Manganese, Selenium, Chromium, Molybdenum, Sodium, Potassium, Fluoride and Chloride.

Products Covered: Food supplements

Regulation Type: Regular notification

Distribution date: 11 April 2003

National minimum and maximum limits for vitamins and minerals in food supplements per daily dose of product as recommended according to labelling, cf. attachment. The notified vitamins and minerals are Vitamin A, Vitamin D, Vitamin E, Vitamin K, Tiamin, Riboflavin, Niacin, Folic acid, Vitamin B6, Pantothenic acid, Vitamin B12, Biotin, Vitamin C, Calcium, Phosphorus, Magnesium, Iron, Copper, Iodine, Zinc, Manganese, Selenium, Chromium, Molybdenum, Sodium, Potassium, Fluoride and Chloride.

Products Covered: Food supplements

Regulation Type: Regular notification

Distribution date: 01 April 2003

The Administration is proposing current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule would establish the minimum CGMPs necessary to ensure that, if you engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, you do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. The provisions would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.

Products Covered: Dietary Ingredients and Dietary Supplements (HS Section IV)  (ICS 71)

Regulation Type: Regular notification

Distribution date: 01 April 2003

The Administration is proposing current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule would establish the minimum CGMPs necessary to ensure that, if you engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, you do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. The provisions would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.

Products Covered: Dietary Ingredients and Dietary Supplements (HS Section IV)  (ICS 71)

Regulation Type: Regular notification

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