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:

    Friday, June 18, 2010

    Smoke-Free Wisconsin and AMA

    The Smoke-Free Wisconsin blog commented on the press release by the American Medical Association (AMA) announcing a resolution that called upon the U.S. Food and Drug Administration (FDA) to regulate electronic cigarettes as drug devices and called for a ban on e-cigaretes that are not FDA-approved. Of course, there are no e-cigarettes that are FDA-approved, so that amounts to a full ban. But wait, there's more. The resolution urged state legislators to ban sales of the products and ban their use in non-smoking areas.

    Here's an extract from the Blog entry:
    Folks who use e-cigarettes say they have quit smoking and have a "smoke-free" life. However you see the product, e-cigarettes do deliver nicotine, not unlike inhalers, lozenges, or gum. All cessation products are regulated by the FDA either as over-the-counter or by prescription.

    The article contains a quote which is quite poignant:
    “Because e-cigarettes have not been thoroughly tested, one cannot conclude that they are less harmful or less dangerous than conventional cigarettes,” said Dr. Langston. “The fact that they come in fruit and candy flavors gives them the potential to entice new nicotine users, especially teens.”
    FDA regulation of e-cigarettes is something we can all support.

    Actually, I can suppport reasonable regulation by the FDA, but not as drug delivery devices. I wonder about that "poignant" quote from Dr. Langston complaining that the products haven't been thoroughly tested. Then why did the AMA resolution also rescind a resolution passed last year supporting testing of the products as a smoking-cessation device. "They haven't been tested enough so let's ban them, and also let's oppose testing them."

    I left the following as a comment on the Smoke-Free Wisconsin blog.
    Yes, e-cigarettes do deliver nicotine, not unlike tobacco cigarette smoke. Unlike smoke, however, e-cigarette vapor does not deliver tar, CO, particles of ash, heavy metals and 4,000 chemical compounds that are created when tobacco is burned, many of which are carcinogenic or toxic. This isn’t rocket science. Even a lay person can figure out that smoke contains a lot more dangerous substances than vapor.

    The true test of any drug’s safety comes after the drug is FDA-approved and can be prescribed for anyone who needs treatment. After the smoking-cessation drug Chantix was approved, there were cases reported of severe depression, anxiety, aggressive behavior, and suicides. FDA-approved Chantix is blamed for at least 78 deaths and over 3,000 serious injuries.

    E-cigarettes have now been thoroughly tested by millions of users and zero serious injuries have been reported. In fact, those who have successfully replaced cigarette smoke with vaporized nicotine are experiencing improvements in their health: Reduction or elimination of wheezing and coughing, better stamina, better markers of cardiovascular health such as blood pressure and lipids.

    The AMA should not be forcing those of us for whom nicotine abstinence is unworkable into a choice between relapsing to smoking or becoming criminals seeking e-cigarette supplies on a black market.

    The FDA is now authorized to regulate tobacco products and should regulate e-cigarettes as a tobacco alternative to ensure that products have manufacturing quality controls in place, accurate labeling, and child-proof packaging.

    I will be astonished if my comment is approved. However, I do invite Erich to leave comments here and begin a dialog for better understanding.