Promotional Lip Balm Imports From Canada Blocked On GMP Problems

In addition to AZX Sport lip balms and hand sanitizers, other topical consumer drugs often considered personal care or cosmetic products outside the US were added in the latest update to FDA's list of import alerts for "detention without physical examination of drugs from firms which have not met drug GMPs."

Canadian firm Aztex Enterprises Ltd. was blocked from distributing its lip balms and hand sanitizers to the US after FDA determined it's using ingredients supplied by a second Canadian firm already on an import alert for good manufacturing practices problems.

In a separate import alert for products deemed unapproved drugs due to the label claims, FDA also recently blocked imports of other topical drugs commonly considered personal care or cosmetic products outside the US (see table below).

Aztex Enterprises, of Burlington, Ontario, operates as "AZX Sport" in supplying exclusively to industry distributors products in promotional packages including conference badges, beverage container wraps and silicone wristbands in addition to FDA-regulated balms and sanitizers.

Aztex Enterprises' lip balms, distributed as promotional products, are blocked from entry to the US due to a suppliers' GMP problems.

Aztex Enterprises Ltd.

Aztex lacked details on how it would correct drug good manufacturing practices when it responded in July to FDA officials' findings from a June inspection. "You also did not perform adequate evaluations of your suppliers," said the Office of Manufacturing Quality in FDA's Center for Drug Evaluation and Research in an Oct. 20 warning letter.

One of the suppliers currently is listed on FDA's import alert for "detention without physical examination" of drugs from firms which have not met drug GMPs, rendering its drug products "subject to refusal of admission to the United States," according to the letter. Aztex' lip balms and hand sanitizers containing this supplier's drug ingredients also are deemed adulterated under FDA regulations.

FDA redacted the name of Aztex' supplier in the warning letter. Other sources familiar with the firms suggested the supplier is Cellex-C International Inc., a Toronto firm that FDA warned in August about GMP problems of its own after its drug products were added to the GMP-failure import alert list in June. Cellex-C manufactures lip balm and hand sanitizers and other types of drug products often considered personal care products but that are regulated as drugs in the US. (Also see "GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports" - Pink Sheet, 15 Aug, 2017.)

According to the most recent update to FDA's drug GMP-failure import alert list, Aztex' lip balms and hand sanitizers were added on Oct. 19.

In its warning to Aztex, FDA said the firm has not established written procedures to properly qualify its suppliers; a formal quality unit with written procedures describing its responsibilities; and written procedures for labeling operations and complaint handling for OTC drug products it ships to the US.

Aztex' management did not respond to a request to comment on FDA's warning letter and import alert.

OTC Drug Import Alerts: Violative Claims
Firm / Location	Products On Import Alert / Violative Claim	Date Added To DWPE List For Unapproved Drugs
Honghui Daily Appliance / Guangzhou, Guangdong, China	Miracle Charcoil Toothpaste / statement on label referring specifically to product "Whitens; Kill germs and freshens breath"	Nov. 6
LMZ International Ltd. (also Liuzhou L.M.Z. Co. Ltd., Liuzhou Liangmianzhen Co., and Lmz International Ltd.) / Luizhou, Guangxi, China	LMZ Herbal Toothpaste / drug claims on product labeling	Sept. 29
El Paradis Cosmetique / Abidjan, Ivory Coast	Nature Secrete with pure Argan oil Lightening Serum and Nature Secrete Lightening Moisturizer Body Lotion / drug claims made on product labeling	Oct. 20
Nouvelle Parfumeria Gandour / Abidjan, Ivory Coast	Bronz Tone / label statement referring specifically to the function of "UV protection"	Aug. 25
International Pharmaceutical Inc. / Cebu, Central Visayas, Philippines	Efficascent Oil (Liniment) / drug claim on label	Oct. 18
FDA Import Alert, Detention Without Physical Examination of Unapproved New Drugs Promoted In the US, Nov. 8.

From the editors of the Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the website.