Today's Links: Toothpaste, melting glaciers, and expensive art

If world financing bodies (including the WTO) do not enact favorable policies to fund china's growth at everyone elses' expense, the members of those bodies will find that corporations from their home countries will have a very difficult time doing business in china.

Nothing good comes from China, nothing.

asienkunde.de/articles/Baraban...

Why does China get 650 million dollars of IFC development funding? Yes, Western China desperately needs the money but the Chinese government is sitting on a trillion dollars, and certainly has money to throw around on its military, the Olympics, and various other ridiculous 'infrastracture' ego projects.

Why doesn't that money go to Africa, South America, South-East Asia? Do those countries not meet transparency requirements? Is the US (through the World Bank) funding wind farms in western China? While the Chinese sit on stockpiled American bonds? Can anyone explain this situation?

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IA #66-74, 5/31/07, IMPORT ALERT #66-74, "DETENTION WITHOUT PHYSICAL

EXAMINATION OF DENTIFRICE PRODUCTS CONTAINING DIETHYLENE GLYCOL (DEG)"

TYPE OF ALERT: Detention Without Physical Examination (DWPE)

NOTE: This import alert contains the Agency's current

guidance to FDA field personnel regarding the

manufacturer(s) and/or product(s) at issue. It does not

create or confer any rights for or on any person and it does

not operate to bind FDA or the public.

PRODUCT: All dentifrice products, including aerosols, liquids,

toothpastes, and tooth powders with or without fluoride

containing DEG

See attachment for specific product and manufacturers

PRODUCT CODE: 53I[][]01 Dentifrice products without Fluoride

63R[][]06 Dentifrice products with Stannous Fluoride

63R[][]05 Dentifrice products with Sodium

Monofluorophosphate

63R[][]04 Dentifrice products with Sodium Fluoride

PROBLEM: Unapproved and adulterated drugs; adulterated and/or

misbranded cosmetics; contains DEG

PAF: AAP, FAD

COUNTRIES: See attachment

MANUFACTURER/

SHIPPER: See attachment

CHARGES: For fluoride containing dentifrice drug products:

"The article is subject to refusal of admission pursuant to

Section 801(a)(3) in that it appears to be a new drug within

the meaning of Section 201(p) without an effective new drug

application (NDA) [Unapproved New Drug, Section 505(a)]."

and

"The article is subject to refusal of admission pursuant to

Section 801(a)(3) in that it appears that the methods used

in, or the facilities or controls used for, its manufacture,

processing, packing, or holding do not conform to or are not

operated or administered in conformity with current good

manufacturing practice to assure that such drug meets the

requirements of this Act as to safety and has the identity

and strength, and meets the quality and purity

characteristics, which it purports or is represented to

possess [Adulterated Drugs, Section 501(a)(2)(B)]."

For non-fluoride containing dentifrice cosmetic products:

"The article is subject to refusal of admission pursuant to

section 801(a)(3) in that it appears to be adulterated in

that it contains a poisonous or deleterious substance,

namely diethylene glycol, which may render it injurious to

users under such conditions of use as are customary or usual

[Adulterated Cosmetic, Section 601(a)]."

RECOMMENDING

OFFICE: CDER, OC, Division of New Drugs and Labeling Compliance

(HFD-310) and CFSAN, Office of Cosmetic and Colors, HFS-608

REASON FOR

ALERT: Diethylene glycol (DEG) is a glycol compound possessing

toxicity similar to ethylene glycol. It is a Central

Nervous System depressant and potent kidney and liver toxin

when ingested. It is commonly used in industry as a

solvent, a thickening agent, a humectant, and as a component

in antifreeze and gas conditioning formulations.

DEG has been improperly used as a low-cost substitute for

glycerin and propylene glycol in pharmaceutical preparations

resulting in various lethal poisoning incidents in humans

worldwide. Among these incidents are, elixir sulfanilamide

in the U.S., sedative mixtures in South Africa, paracetamol

elixirs in Bangladesh and Nigeria, acetaminophen syrup in

Haiti, and a cough expectorant product in India. Most

recently, a cough syrup resulted in serious human injury and

over 40 deaths in Panama in September 2006. These recent

DEG poisoning incidents involved a "glycerin" product

manufactured in China that was a mixture of sorbitol and DEG

and less than one percent glycerin.

In May 2007, FDA received accounts that toothpaste from

China shipped to Panama, Australia, and the Dominican

Republic was found to contain DEG. A significant amount of

toothpaste from China is imported into the United States.

FDA is presently sampling dentifrice products manufactured

in China to determine potential contamination with DEG.

To date, FDA has found DEG in three products manufactured by

Goldcredit International Trading, China. The products are

Cooldent Fluoride, Cooldent Spearmint, and Cooldent ICE.

Analysis of these products has revealed that they contain

between 3 and 4 percent diethylene glycol. FDA has also

found DEG in one product manufactured by Suzhou City Jinmao

Daily Chemicals Co., China. Analysis of that product, Shir

Fresh Mint Fluoride Paste, found that it contained

approximately 1% DEG. These products have been included in

the DPWE list attachment of this alert. As the agency

identifies other toothpaste products containing DEG, these

products and their manufacturers will also be added to the

Import Alert.

The products were labeled as containing diglycol. Diglycol

is one of many synonyms of diethylene glycol. According to

REPROTEXT System, diethylene glycol may be also known as:

1. Brecolane ndg

2. Carbitol

3. Deactivator E

4. Deactivator H

5. DEG

6. Degrees

7. Dicol

8. Diethylene ether

9. Diethylene glycol

10. Diethylenglykol (Czech)

11. Digenos

12. Diglycol

13. Digol

14. Dihydroxydiethyl ether

15. 2,2'-Dihydroxydiethyl ether

16. beta,beta'-Dihydroxydiethyl ether

17. Dihydroxyethylether

18. 2,2'-Dihydroxyethyl ether

19. Dissolvant APV

20. Ethanol, 2,2'-oxybis-

21. Ethanol, 2,2'-oxydi-

22. Ethylene diglycol

23. Glycol ether

24. Glycol ethyl ether

25. 2-Hydroxyethyl ether

26. bis(2-Hydroxyethyl)ether

27. 3-Oxapentane-1,5-diol

28. 3-Oxa-1,5-pentanediol

29. 2,2'-Oxybisethanol

30. 2,2'-Oxybis-ethanol

31. 2,2'-Oxydiethanol

32. 2,2'-Oxyethanol

33. TL4N

FDA has also identified a number of other dentifrice

products manufactured by Goldcredit that are labeled as

containing DEG(or a synonym thereof). These products have

also been included in the DWPE list on this alert.

Dentifrice products may be marketed in the United States as

drugs or cosmetics. Dentifrice products intended to prevent

or mitigate dental cavities/decay (anticaries toothpaste)

are regulated as over the counter (OTC) drugs. OTC

anticaries toothpaste containing diethylene glycol cannot be

marketed in the U.S. without an approved new drug

application (NDA). DEG can be toxic and even fatal in

humans and FDA is not aware of DEG having been used for a

material extent and time in formulating OTC anticaries drug

products. Thus, FDA regards any OTC anticaries drug product

containing DEG to be a "new drug" as defined by section

201(p) of the Federal Food, Drug, and Cosmetic Act (the

Act). "New drugs" must be the subject of an approved NDA

under section 505 of the Act to be legally marketed in the

United States. Presently, there are no OTC anticaries drug

products containing DEG approved for marketing in the U.S.

The use of DEG in OTC anticaries drug products causes them

to be adulterated under section 501(a)(2)(B) of the Act

because of the toxicity of DEG when ingested, and therefore,

the methods or controls used to manufacture the anticaries

drug containing the DEG do not conform to current Good

Manufacturing Practices to assure the drug meets the

requirements of the Act regarding safety.

Non-fluoride dentifrices products that are not drugs are

ordinarily marketed as cosmetics, as their intended use is

for oral hygienic cleansing.

At this time, the only DEG-containing dentifrice products

identified by FDA as being offered for import into the U.S.

are from China. However, no DEG-containing dentifrice

products manufactured in China or any other country may be

imported into the U.S. Therefore, this alert covers

dentifrice products containing DEG from any source.

GUIDANCE: Districts may detain without physical examination all

shipments of dentifrice products listed in the attachment.

Districts may detain without physical examination any

shipment of dentifrice products labeled as containing

diethylene glycol or any of its synonyms.

For questions regarding dentifrice product marketed as drugs

please contact CDER Import-Export Team at 301-827-8967.

For questions regarding dentifrice product marketed as

cosmetics please contact, Richard Jewell, CFSAN, Labeling

Compliance Team, at 301-436-2596 or

Richard.jewell@fda.hhs.gov

PRIORITIZATION

GUIDANCE: I

FOI: No purging required

KEYWORDS: toothpaste, mouthwash, dentifrice, DEG

PREPARED BY: Ada Irizarry /CDER/OC/DNLC, 301-827-8967

Richard Jewell, CFSAN, HFS-608, 301-436-2596

Doug Randes, DIOP, 301-443-6553

DATE LOADED

INTO FIARS: May 31, 2007

ATTACHMENT TO IMPORT ALERT #66-74 5/31/07

"LIST OF DENTIFRICES PRODUCTS MANUFACTURED THAT CONTAINS DIETHYLENE GLYCOL

(DEG) AND/OR ARE LABELED AS CONTAINING DIETHYLENE GLYCOL

Manufacturer Products

1. Goldcredit International Enterprises LTD Cooldent Fluoride

666 Shuguang Bei Rd Cooldent Spearmint

Hangitown Cooldent ICE

Yangzhou, China Dr Cool Toothpaste

FEI# 3005396179 Everfresh Toohpaste

Superdent Toothpaste

Other addresses:

Goldcredit International Enterprises, LTD

9 F Wuxi National Ind. Design District

Liyuan Economic Dev Zone

Wuxi Chin, China

FEI# 3005043484

3005446962

Goldcredit International Enterprises, LTD

#151 Lakebank Elegant Gardenwest

Jincheng Road

Wuxi, Jiangsu, China 214123

FEI# 3005775027

3005854733

2. Gold Credit International Trading Co LTD Clean Rite Toothpaste

17th fl Changquing Bldg. Clean Rite Toothpaste

6 Jie Fang North Rd Kit

Wuxi 214005 Oralmax Extreme Action

Jiangsu, China Kit

FEI# 3005535612 Oralmax Extreme Action

3005566861 Pack Kit

3005970990 Oral Bright Fresh

3003883350 Spearmint Flavor

Bright Max Peppermint

Flavor

Other addresses:

Gold Credit International Trading Co LTD

20 Floor Unit G Wah Kwong Bldg. 333

Zhongsnan Rd, Wuxi 214001

Jiangsu , China

FEI# 3003754241

3. Suzhou City Jinmao Daily Chemicals Co. Ltd. ShiR Fresh Mint

Jingeng Village Huangqiao Town Fluoride Paste

Xiangcheng Dist. Suzhou Jiangsu China

Suzhou City, China

FEI# 3005225258

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