An announcement from the FDA:

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Labeling OTC Skin Protectant Drug Products.'’ This guidance provides recommendations on how to label over-the-counter (OTC) skin protectant drug products. An OTC skin protectant active ingredient can be combined with another OTC skin protectant active ingredient or OTC external analgesic, first aid antiseptic, or sunscreen active ingredients. Each of these combinations has specific labeling requirements, and therefore labeling of OTC skin protectant drug products is complex. This guidance is designed to clarify the permitted combinations of active ingredients along with the corresponding required labeling.

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 3, 2008.

Click on the link for more information.

But not for consumer products, according to a recent article:

The classification and communication of chemical hazard labelling will be implemented in the industrial and agriculture sectors apart from consumer products by 2010, said Deputy Human Resource Minister Datuk Noraini Ahmad…

“Unlike in the European countries, Malaysia was a bit slow in implementing the GHS because it had to be carried out in stages and with the agreement of the other nine Asean countries,” she told reporters after opening the two-day Chemical Management at the Work Place Seminar here Wednesday…

Noraini said after the implementation of the GHS, all imported products would be uniformly labelled and classified to facilitate their usage in the chemical industry. “For example, the chemical elements in imported hair shampoos sold in Malaysia were not uniformly labelled and unclear because of the differences in labelling definitions, thus they needed to be harmonised,” she said.

Click on the top link for the full article.

Nexreg has more information on GHS at the following link:

• GHS Strategic Planning (English)

To speak to a Nexreg representative about how GHS or REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

The new environmental guidelines we mentioned earlier in the week have been released. A press release from the competition bureau states:

Environmental Claims: A Guide for Industry and Advertisers addresses a number of commonly used green claims and provides examples of best practices on how such claims can be used by businesses to comply with the false or misleading provisions of the laws enforced by the Competition Bureau. Among other practices, the Guide states that:

• The use of vague claims implying general environmental improvement are insufficient and should be avoided.
• Environmental claims should be clear, specific, accurate and not misleading.
• Environmental claims should be verified and substantiated, prior to being made.

…The Bureau recognizes companies may wish to reassess their advertising and labelling in light of the Guide. A one-year transition phase will allow legitimate businesses to change their marketing practices, if necessary, and will also allow the Bureau and CSA to raise awareness and understanding on the new environmental guidelines.

During this one-year transition period, the Bureau will not hesitate to pursue egregious cases of deceptive environmental claims.

Although the Guide is not law, following the best practices outlined will help businesses to avoid making misleading claims that contravene the laws enforced by the Bureau. The Guide will be used by the Bureau to assess environmental advertising that raise concerns under its legislative mandate.

Click on the above link for the full press release.

We highly encourage our colleagues and clients to ensure that their labels comply with the guidelines. A PDF copy of the guidlines is available here (PDF).

First of all, we would like to welcome you to our newly re-designed news site. We hope that you find it easier to navigate than the previous version of Regulatory News by Nexreg Compliance. The site has not been tested against every possible browser and resolution combination. If you find any display errors, we would appreciate it if you let us know by e-mail at info@nexreg.com

In other news, Nexreg Compliance is introducing three free regulatory compliance newsletters. The two-page newsletters summarize major chemical compliance news and will be released bi-monthly. The three newsletters are as follows:

• Canadian Regulatory Compliance News
• U.S. Regulatory Compliance News
• Global Regulatory Compliance News (covering GHS, REACH, etc.)

The first issue of the Canadian newsletter has just been released. If you wish to receive copies of one or all over the newsletters sent by mail or by e-mail (as a PDF file), please send your contact information to info@nexreg.com.

Could nanomaterial labeling regulations be coming to the EU? EurActiv.com discusses:

The EU executive’s regulatory review of existing European legislation concludes that current laws may need to be modified as the depth of scientific knowledge on nanomaterials increases. Specific labelling schemes for products containing nanomaterials could notably be developed.

The current EU legislative framework “covers in principle the potential health, safety and environmental risks in relation to nanomaterials,” concludes a Commission Communication on regulatory aspects of nanomaterial, published on 17 June 2008…

As for labelling of products, the Commission does not exclude the possibility “that a need would be identified for specific labelling requirements” for nanomaterials. Until then, it says, nanomaterials must comply with the existing EU law on the labelling of products, warnings and other information for consumers on the properties of products.

Click on the above link for more information.

A proposed rule from the FDA: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling:

The Food and Drug Administration (FDA) is proposing to amend its regulations concerning the format and content of the “Pregnancy'’, “Labor and delivery'’, and “Nursing mothers'’ subsections of the “Use in Specific Populations'’ section of the labeling for human prescription drug and biological products. The agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling would also include relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. The proposal would eliminate the current pregnancy categories A, B, C, D, and X. The “Labor and delivery'’ subsection would be eliminated because information on labor and delivery is included in the proposed “Pregnancy'’ subsection. The proposed rule is intended to create a consistent format for providing information about the effects of a drug on pregnancy and lactation that will be useful for decisionmaking by women of childbearing age and their health care providers.

For more information click on the above link.

The Government of Canada has just released a Fact Sheet on Bill C-51:

Bill C-51 will not affect the way that natural health products are regulated in Canada. The Natural Health Products Regulations, introduced in 2004, will continue to operate the same way under the proposed Bill C-51. Bill C-51 has been drafted to complement and support current policies for natural health products.

The Natural Health Products Regulations already recognize that natural health products are different from drugs, and that the evidence requirements for drugs are not appropriate for natural health products. Bill C-51 does not change this. In fact, Bill C-51 supports different requirements for different types of products. Therefore, the standards that are used to assess the risks and benefits of natural health products will continue to incorporate history of use, traditional uses and cultural practices.

The regulated activities for natural health products have already been identified in the Natural Health Products Regulations, and do not change. These regulated activities are: manufacturing, packaging, labelling, importation and distribution of natural health products for sale. Revisions to the list of controlled activities in Bill C-51 are only for cells, tissues and organs.

For more on Bill C-51 click on the above link. The full text of the act can be found here: Food and Drugs Act.

Recent article from NutraIngredients:

“Certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or to ensure the healthy growth of food crops. Excessive exposures to these same chemicals or compounds can cause cancer or adverse reproductive effects,” said OEHHA.

“OEHHA is seeking a way to balance the need for these nutrients with the necessity for providing Proposition 65 warnings for exposures to listed chemicals in foods.”

Under the draft regulatory language, the agency proposes that if a listed chemical is shown to be beneficial to human health and does not exceed the Recommended Daily Allowance (RDA), then consumption of this in a food would not be considered ‘exposure’.

The agency said that a chemical is considered beneficial to human health if a daily value or allowance has been established for it by the Institute of Medicine (IOM).

Click on the above link for the full article.

An annoucement recently posted in the Canada Gazette:

Interim Marketing Authorization

Provision currently exists in the Food and Drug Regulations for the use of L-leucine as a lubricant at a maximum level of use of 3% of tablet weight in the manufacture of table-top sweetener tablets containing aspartame.

Health Canada has received a submission to permit the use of L-leucine as a lubricant and/or binder in table-top sweetener tablets containing sucralose. Evaluation of available data supports the safety and effectiveness of L-leucine as a lubricant and/or binder in table-top sweetener tablets.

The use of L-leucine will benefit consumers through increased availability of quality table-top sweetener products. It will also benefit industry through more efficient and improved manufacturing conditions.

Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of L-leucine as a lubricant and/or binder in table-top sweetener tablets at levels consistent with good manufacturing practice.

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 L-leucine in the manufacture of table-top sweetener tablets containing sucralose, at levels consistent with good manufacturing practice, while the regulatory process is undertaken to formally amend the Regulations. Click on the above link to read the full annoucement.

First, Regulations Amending the Food and Drug Regulations (1528 — Schedule F):

1. The reference to

Botulinum Toxin Type A

Antitoxine botulinique, Type A

in Part I of Schedule F to the Food and Drug Regulations… is replaced by the following:

Botulinum toxin Type A

Toxine botulinique, type A

2. Part I of Schedule F to the Regulations is amended by adding the following in alphabetical order:

Alglucosidase alfa

Alglucosidase alfa

Darunavir

Darunavir

Natalizumab

Natalizumab

Rasagiline and its salts

Rasagiline et ses sels

Sorafenib and its salts

Sorafénib et ses sels

Tigecycline

Tigécycline

Second, Regulations Amending the Food and Drug Regulations (1541 — Schedule F):

1. The reference to

Diclofenac and its salts

Diclofénac et ses sels

in Part I of Schedule F to the Food and Drug Regulations… is replaced by the following:

Diclofenac and its salts, except when sold as a single medicinal ingredient in a concentration equivalent to 1% or less diclofenac in preparations for topical use on the skin

Diclofénac et ses sels sauf s’ils sont vendus comme ingrédient médicinal unique en une concentration maximale de 1 % dans les préparations pour usage topique sur la peau