Released on: October 1st, 2011
Author: Maggie Luo (from riva-ecigar.com)
Industry: Electronic cigarette, PV

The U.S. Food and Drug Administration today issued warning letters to five electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.
In a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health. The letter outlines the regulatory pathway for marketing drug products in compliance with the FDCA.
For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product.
“FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the letter to the association read.
FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs. Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug’s safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes.
The companies receiving warning letters today are: E-Cigarette Direct LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC.
Certain companies received warning letters for additional reasons. For example, E-Cig Technology markets drugs in unapproved liquid forms, such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States. These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so that the drugs can be vaporized and inhaled.
The FDA cited Johnson Creek Enterprises, which markets Smoke Juice, a liquid solution used to refill depleted cartridges in e-cigarettes, for several significant deficiencies in its manufacturing processes, including failure to establish quality control and testing procedures required under the FDCA.
For more information:
• Letter to Electronic Cigarette Association (PDF - 39KB)
• Questions and Answers
• FDA Analysis of E-Cigarettes
• Center for Drug Evaluation and Research
• Warning Letters:
- E-CigaretteDirect LLC
- Ruyan America Inc
- Gamucci America (Smokey Bayou Inc)
- E-Cig Technology Inc
- Johnson’s Creek Enterprises LLC

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About riva-ecigar.com:
Electronic cigarette manufacturer and wholesaler from China, which is always dedicated to bring innovative product design with low defective rate to electronic cigarette industry, not only have humanistic function design but also contractive cosmetic design.

For further information contact:
Shenzhen Beautiful Technology Co.,Ltd
Maggie Luo
Website: http://www.riva-ecigar.com

I'm not sure what the point of this Riva press release is. This is old news--like more than a year old (even though the press release indicates that it happened "today"). After losing at both the federal district level and federal appellate level, the FDA has since specifically agreed to regulate e-cigarettes as tobacco products absent therapeutic claims.

While the issue of what constitutes a therapeutic claim will no doubt still be a point of contention, no one is considering these warning letters as especially relevant or probative.

In sum, this is a misleading press release.

I also should say that anyone who is concerned about the FDA's claim that Johnson's Creek's has several deficiencies in its manufacturing process . . . don't be.

What the FDA was claiming was that Johnson's Creek failed to meet the very rigid and stringent regulations associated with manufacturing drugs . . . Johnson's Creek isn't manufacturing drugs and isn't subject to those standards. Johnson's Creek has a very clean and professional facility, and I have no concerns at all about the quality of Johnson's Creek's liquids.

Awesome posts Julie!! As usual... wise Julie is WISE!!

isnt that letter the same one as last year about this time. oh nm i see julie answered already.