Distribution date: 09 January 2007 | Final date for Comment: 23 April 2025

The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.

Products Covered: Dairy cream: International Classification for Standards (ICS) code 67.100; HS tariff headings 04.02 and 04.03

Regulation Type: Regular notification

Distribution date: 09 January 2007 | Final date for Comment: 23 April 2025

The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labelling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include new warnings and other labelling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labelling for all OTC IAAA drug products. The new labelling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labelling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use.

Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS:  Chapter 3004; ICS:  11)

Regulation Type: Regular notification

Distribution date: 09 January 2007 | Final date for Comment: 23 April 2025

The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labelling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include new warnings and other labelling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labelling for all OTC IAAA drug products. The new labelling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labelling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use.

Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS:  Chapter 3004; ICS:  11)

Regulation Type: Regular notification

Distribution date: 10 January 2007 | Final date for Comment: 23 April 2025

The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to: Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis.

Products Covered: Food Labeling (HS:  Chapter 2936; ICS:  67.040)

Regulation Type: Regular notification

Distribution date: 10 January 2007 | Final date for Comment: 23 April 2025

The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to: Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis.

Products Covered: Food Labeling (HS:  Chapter 2936; ICS:  67.040)

Regulation Type: Regular notification

Distribution date: 10 January 2007 | Final date for Comment: 23 April 2025

Products Covered: Cosmetics (HS:  3300)

Regulation Type: Regular notification

Distribution date: 10 January 2007 | Final date for Comment: 23 April 2025

Products Covered: Cosmetics (HS:  3300)

Regulation Type: Regular notification

Distribution date: 16 January 2007 | Final date for Comment: 23 April 2025

The US Food and Drug Administration is proposing to amend the calcium and osteoporosis health claim regulation (21 CFR 101.72) to: (1) Include vitamin D so that, claims can be made for calcium and vitamin D and osteoporosis; (2) eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; (3) eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general United States population, and that the claim identify the populations at particular risk for the development of osteoporosis; (4) eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and (5) eliminate the conditional requirement that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake. This proposal responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, the Coca-Cola Company.

Products Covered: Not applicable

Regulation Type: Regular notification

Distribution date: 16 January 2007 | Final date for Comment: 23 April 2025

The US Food and Drug Administration is proposing to amend the calcium and osteoporosis health claim regulation (21 CFR 101.72) to: (1) Include vitamin D so that, claims can be made for calcium and vitamin D and osteoporosis; (2) eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; (3) eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general United States population, and that the claim identify the populations at particular risk for the development of osteoporosis; (4) eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and (5) eliminate the conditional requirement that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake. This proposal responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, the Coca-Cola Company.

Products Covered: Not applicable

Regulation Type: Regular notification

Distribution date: 19 January 2007 | Final date for Comment: 23 April 2025

Products Covered: Accident Action Pack (ICS:  13.200)

Regulation Type: Regular notification