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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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