Thursday, June 24, 2010

FDA Misleading Report Strategy Backfires

Since the fall of 2008, the U.S. Food and Drug Administration (FDA) has been at war with the electronic cigarette (e-cigarette) industry. Claiming that the products are drug/device combination products that can be regulated by the agency under the Food Drug and Cosmetic Act, (FDCA), FDA began banning the import of e-cigarettes.

E-cigarettes are devices composed of a cartridge, a heating element, a battery, and electronics. When the user inhales, the device is activated and some of the liquid in the cartridge is vaporized, delivering a small amount of nicotine in a mist that has the appearance of smoke.

FDA's notices to the e-cigarette vendor Smoking Everywhere (SE) stated that SE's products "are intended to alter the structure or function of the body because they contain nicotine." Smoking Everywhere offered to revise labels and websites to satisfy FDA that "this product is intended solely for recreational use ... and not intended to effect the structure or function of the body and not intended to treat, cure, mitigate or treat a disease." FDA refused, and continued seizing products.

On April 28, 2009, SE brought suit against the FDA in the United States District Court for the District of Columbia. The suit challenged FDA’s authority to regulate and ban imports of e-cigarettes under the drug/device provisions of the FDCA. On May 15, 2009, Soterra, an Arizona company doing business as NJOY, joined SE as an intervenor-plaintiff, and NJOY filed its own complaint.

In June 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Act), giving the FDA statutory authority to for comprehensive regulation of the content, testing, development, manufacture, labeling, packaging, advertising, promotion, distribution, and sale of any "tobacco product."

In January 2010, the Honorable Richard E. Leon, Judge for the U.S. District Court, granted an injunction in favor of the plaintiffs, SE and NJOY, ordering FDA to refrain from seizing incoming shipments until the case has been decided. Judge Leon rejected FDA's argument that e-cigarettes should be regulated as a drug/device combination under the FDCA because the products are not sold with a therapeutic purpose. Judge Leon pointed out that, since the products contain nicotine derived from tobacco, they meet the definition of a tobacco product under the Tobacco Act.

Judge Leon's opinion pointed out that the FDA's purported public health concerns regarding e-cigarettes were not supported by the evidence. The court explained that advertising the products as a healthier alternative to smoking does not constitute a therapeutic claim. The Tobacco Act allows for "modified risk tobacco products" which are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." Judge Leon pointed out that if the FDA did have concerns about public health, it could regulate the contents, labeling, and marketing of e-cigarettes under the Tobacco Act.

FDA chose, instead, to leave the products totally unregulated and filed an appeal. On March 31, 2010, the appeals court granted a stay pending appeal. The stay temporarily lifts the injunction, allowing FDA to resume seizing shipments of SE and NJOY products. In its brief filed on May 24, 2010, the FDA attempted to shore up its argument that the products are potentially dangerous by introducing as evidence findings announced in July 2009 regarding testing of 18 SE and NJOY cartridges in March.

The lab report noted that some Tobacco-Specific Impurities (TSIs) were "detected," along with Tobacco-Specific Nitrosamines (TSNAs), some of which can be carcinogenic. The FDA's press announcement stated, "A laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol [DEG], an ingredient used in antifreeze." The wording was calculated to convey the false impressions that e-cigarettes are more carcinogenic and more toxic than tobacco cigarette smoke.

This strategy played well in the press, convincing untold numbers of smokers to continue inhaling tar, carbon monoxide, particles of ash, heavy metals, and many more dangerous substances found in smoke, but absent from e-cigarettes. However, it was a strategic error on FDA's part to introduce the lab report into the court record.

NJOY's attorneys have taken advantage of this opening by analyzing the report authored by FDA scientist B.J. Westenberger and incorporating the results into the NJOY appeal brief filed with the court on June 23, 2010. The NJOY brief noted the following facts:

  • The amount of nicotine required to create a significant adverse effect is considerably higher than the levels Westenberger found in e-cigarettes.

  • The e-cigarette cartridge itself is neither ingested directly nor handled extensively,and thus the likelihood of significant exposure to DEG found only in the cartridge is therefore very low at best.

  • No tests were performed to confirm the presence of DEG in the vapor.

  • The TSNA levels were so low they could not even be quantified, and the TSI levels were less than the specification for the cartridge of the FDA-approved smoking cessation device, Nicotrol.

  • The evidence, moreover, demonstrates no harmful TSNAs or TSIs in the vapor that smokers actually inhale.

  • Links:

    Smoking Everywhere Complaint:

    FDA's Brief in Opposition:

    Judge Leon's Ruling:

    Judge Leon's Opinion:

    FDA's Appeal:

    FDA's Lab Report:

    Exponent Analysis of FDA Report:

    Analysis of TSNAs in NJOY:

    NJOY Appeal Answer Brief:


    1. Wouldn't it be sweet if the FDA got hung out to dry in the appeals court by submitting their own July 2009 disinformation.

    2. Yes, indeed. The NJOY brief also addressed the claim that e-cigarettes are being sold to children: "The suggestion that these electronic devices are likely to be attractive to minors has no support in the record. FDA has produced absolutely no data demonstrating that minors use these products or consider them a desirable alternative to smoking." Unlike the media, the courts don't consider every word that falls from a government agency employee's mouth to be gospal truth. If you make an allegation, you need to be able to prove it.

    3. It would be interesting to see an independant lab test some cartridges or e-liquid. As a manufacturer of e-liquid I find it very tempting to get samples of my own liquid tested in this way.

      I also wonder if the TSI's and TSNA's are coming from the Nicotine or from the Tobacco Absolute that is sometimes used in e-liquid.

      More testing can only help the cause ...

    4. Testing of any product, even FDA-approved pharmaceuticals, is almost always funded by the manufacturer. An independent lab that skewed its results based on who paid for the tests wouldn't stay in business very long. You might want to check out the lab reports here:

      If you are manufacturing e-liquid, you should be having your products batch-tested on a regular basis, to protect consumers and to protect yourself from liability claims.