FDA Regulations on E-Cigarettes: When Public Safety May Not Be The Primary Concern
FDA regulations as they apply to e cigarettes and all components have been the center of much discussion throughout the vaping community. The primary concern is the potential for these new regulations to eradicate over 99% of the vaping industry. Many have pointed in the direction of big tobacco companies as the guilty party behind these draconian rules, however there is yet another industry that e-cigarettes directly compete against.
What will be left once the FDA regulations are in full force?
According to a survey conducted by CASAA in the fall of 2015 of over 20,000 e cigarette users, 87% were former smokers. While a large percentage of vapers claimed that they would simply order their products from overseas, U.S. Customs and Border Protection is routing all inquiries concerning the import of vapor products to the FDA. With more stringent restrictions inevitably contributing to vaping becoming a less viable option, three options remain. Return to smoking, use Nicotine Replacement Therapy (NRT), or quit smoking/vaping altogether.
Many are focused on how much the tobacco industry stands to gain from the demise of the vaping industry. However, the largest companies in the pharmaceutical industry and manufacturers of NRT’s, have been more overtly and visibly pressuring the FDA for e-cigarette regulation. These blatant moves seem to have gone on mostly unnoticed.
Who are the major players pushing for strict FDA regulations on e-cigarettes?
The Campaign for Tobacco Free Kids has been one of the driving forces urging the FDA to regulate e cigarettes and components under the umbrella of tobacco products. This may simply be a reasonable move for an organization with such clearly defined designation, but there are some interesting coincidences that deserve a closer look. In 1995, the Robert Wood Johnson Foundation established the National Center For Tobacco-Free Kids, and in 1996 the organization changed its name to The Campaign for Tobacco Free Kids. Since its inception, the Robert Wood Foundation has given The Campaign for Tobacco Free Kids $112,590,489 in grant monies.
The Robert Wood Johnson Foundation was created upon the death of Robert Wood Johnson II, better known for his family firm Johnson & Johnson. The Robert Wood Foundation currently owns 13,000,000 shares of Johnson & Johnson, a company that most might associate with household general goods like soap and baby shampoo. Johnson & Johnson however also controls the market for NRT products, along with GlaxoSmithKline, Pfizer, and Novartis. As early as 2014, Bloomberg reports that at least 3 of these 4 pharmaceutical giants were lobbying for the stringent control of electronic cigarettes. “Safety is our number one priority and we support the smoker’s right to choose from a selection of products that have well established safety and efficacy profile in helping them quit smoking. All nicotine-containing products including e-cigarettes should be reviewed and regulated to the same standard of safety,” stated Simon Steel, a spokesman for Glaxo. However, this statement appears to be inconsistent with the company’s practices. Glaxo has been sued countless times over numerous safety concerns regarding their products. Zofran for nausea, “proven safe during pregnancy,” caused hundreds of birth defects. Antidepressant Paxil has cost the company over $1 billion in settlements for birth defects, addictions, and suicides. Avandia for diabetes has spurred thousands of lawsuits for heart attacks, liver failure, stroke, and death. A lawsuit concerning NRT Nicoderm has emerged due to an employee discovering its, “capacity to cause negative consequences and potential health and safety issues for the general public,” and being victimized for attempting to report his findings according to CNBC.
Contradictions in FDA regulations of medications and more?
In addition to these outside influences, a considerable contradiction existed within the FDA itself. Former Commissioner of the FDA Margaret Hamburg is being charged in a Federal Lawsuit with, “conspiracy, racketeering & colluding to conceal deadly drug dangers.” The lawsuit states that Levaquin among others allegedly caused over 5,000 deaths. It states that the dangers of these medications were concealed from the public and health professionals by Hamburg while acting as FDA commissioner. The lawsuit charges Hamburg and her husband Peter Brown, “with collusion, conspiracy and racketeering alongside the pharmaceutical giant, Johnson & Johnson to conceal those deadly risks — to protect their financial stake.” It is worth noting that Peter Brown is co-CEO of hedge-fund Renaissance Technologies who has holdings in Johnson & Johnson, GlaxoSmithKline, Pfizer, and Novartis, as well as the two largest tobacco companies: Philip Morris and Reynolds.
The lawsuit, filed in April of 2016 alleges that, “Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation.” In addition to this, Hamburg, “failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest –specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock,” and, “jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees.” During Hamburg’s time serving as Commissioner of the FDA, “her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012.”
Commissioner steps down, will her replacement provide unbiased FDA regulations?
In January of 2015, Hamburg appointed Dr. Robert Califf as the FDA’s Deputy Commissioner for Medical Products and Tobacco. According to Time magazine, “Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure.” Forbes reported that, “Califf’s largest consulting payment of $87,500 was received from Johnson & Johnson in 2012.” In April of 2016, Califf was appointed as the Commissioner of the FDA replacing Hamburg.
Clearly, Hamburg should never have been considered for a position that decidedly requires impartiality for regulatory purposes. Regardless, it seems that a closer examination of the extent to which conflict of interest exists within our government agencies is long overdue.