GOBIERNO DE PUERTO RICO

Agency cites unsubstantiated claims, poor manufacturing practices

The U.S. Food and Drug Administration today issued warning letters to five distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.
Also today, in a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarettes 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-CigaretteDirect 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 AssociationQuestions and Answers

FDA Analysis of E-Cigarettes

Center for Tobacco Products

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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