Tuesday, September 29, 2015

FDA Completely Misinterprets Food, Drug, and Cosmetic Act in Warning Letters to E-Cigarette Company

My examination of the warning letter written by the FDA to Johnson Creek reveals that the agency is completely misinterpreting the Food, Drug, and Cosmetic Act's (FDCA) definition of what is considered a "therapeutic claim." This warning letter, issued in 2010 to Johnson Creek - an e-liquid manufacturer - asserted that certain claims being made by this company were therapeutic claims, and therefore, the products made by the company were considered drugs and had to be pulled from the market as they were not approved by the FDA as drugs.

However, upon examination, I found that this letter misinterpreted the meaning of "therapeutic claim" and used as evidence to support its assertion statements that do not actually represent therapeutic claims at all.

Below, I review many examples from the warning letter of the agency's misinterpretation.

The Rest of the Story

Examples of Purported Therapeutic Claims From the Letter to Johnson Creek

"If i had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again, with as good as I feel right now. Daniel L. ... 

I have been off tobacco cigarettes for a week. I have been using an NJOY. I just received my first of many orders from your company. Norman S."

These two comments from customers simply express their experiences with electronic cigarettes. In both cases, these customers were able to switch completely from cigarettes to e-cigarettes. The company is not making any therapeutic claims, but is merely sharing the experience of customers who were able to switch from cigarettes to e-cigarettes. There is nothing in these comments which suggests that Johnson Creek e-liquids are intended either to prevent or treat any disease or to affect the function or structure of the body. Nothing in the comments expresses anything about improved health. They simply convey the fact that these individuals have switched from tobacco cigarettes to electronic cigarettes.

To see misguided the FDA is on this point, consider the following claim that is currently being made by GNC in the same context (a testimonial from a customer):

"GNC is the supplement industry leader in providing the highest quality supplements at an affordable price. I would like to thank GNC for making me a better athlete and a healthier person through the GNC supplements that I include in my daily nutrition."

Here, GNC is directly claiming that using its products will improve your health. This certainly seems like a therapeutic claim. After all, improving your health implies prevention of lack of health (i.e., disease or a harmful condition). This appears to run afoul of federal law, which prohibits nutritional supplements from making "disease" claims. The manufacturers of these products are not allowed to make any claim which states or implies that their products are intended to or can prevent a disease or adverse health condition. Apparently, the FDA does not view this as a health claim, since it allows claims like this to be made daily by GNC and similar companies. Also, the manufacturers are required to notify the FDA of the claims they are making, so presumably the agency is aware of this claim but has not taken any action against GNC, even though they are hounding Johnson Creek for making what is in comparison an innocuous claim.

Consider also the following claims which are being made by Faith & Family Nutrition, another nutrition supplement seller:

"J. Randsdorp on real pain relief without drugs or surgery
Dear Doctor, I saw you on TBN-TV ... I then ordered the vitamins for joint integrity, and I cannot believe I have my life back. I am a Christian, but everyday I had started my day with pain. After taking the vitamins, I painted a room! And now everyday when my feet hit the floor, it is without pain. I can't believe it but it’s true. I thank God for you. My right leg is completely pain free and there’s just a small amount in my left leg. — D.H., Monroe, La.
...He truly is doing better! His sense of humor has returned. He is already remembering words, not stammering over them. His 'pleasant' personality is being restored. His driving, which we could not get him to stop, is much better." (on Alzheimer's supplement recommendation plan) — R.D., Ortonville, Mich.

My husband has been taking the supplements for Alzheimer's for two months and is doing quite well. His long-term and short-term memory is starting to return. I took him out of the nursing home to give him the supplements, and the nurses at the nursing home are amazed at his improvement and want to know what he has been given. (on Alzheimer's supplement recommendation plan) — M.H. Huron, S.D.

My father was having epileptic seizures. Those stopped with the Relief Pills. He has trouble with short- and long-term memory and is doing much better. He is even seeing better: He can see colors now. Before he only had peripheral vision." (on Brain Food, Seizure Relief and other various supplements)
— C.S, Molalla, Ore.

I had a bad case of insomnia. I'm sleeping great now due to 5-HTP. And my husband's hair is growing thicker since taking IGF Growth Factor. — P.M., Nashville, Tenn.
I had a torn rotator cuff in my shoulder, and Natural Joint Integrity took away the pain. (The doctor said my shoulder was messed up pretty bad.) It also has helped my back. I used to get acupuncture, but haven't had to in a long time since taking Natural Joint Integrity. — D.W., Sullivan, Mo."
Here, the nutritional supplement company is making claims - presumably reviewed by the FDA and not judged to be disease claims - which directly assert that its products will relieve pain, treat the symptoms of Alzheimer's disease, prevent seizures in patients with epilepsy, treat insomnia, and relieve pain from a rotator cuff injury.

Yet the FDA does not consider these to be disease claims! Instead, it is writing threatening letters to companies whose testimonials do not even mention any disease or condition.

Other examples from the warning letter to Johnson Creek:

"E-Smoking vs. Cigarette Smoking ... To many who take up e-smoking, it completely takes over for regular cigarette smoking. In fact many report never picking up a cigarette again after starting to e-smoke ... 

Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ..."

The first claim simply notes that many customers were successful in switching from tobacco cigarettes to e-cigarettes. It doesn't mention or imply the prevention or treatment of any disease.

The second claim actually is an "anti-drug" claim. In other words, it makes it exquisitely clear that this product is meant to replace the physical and emotional stimuli associated with smoking, rather than to treat nicotine addiction. How does this statement possibly represent a therapeutic claim, especially in light of the "non-disease claims" being made by nutritional supplement companies?

In contrast, some of the claims being made by E-Cigarette Direct, another company to which FDA sent a warning letter, are therapeutic claims.

For example:

"Wean yourself off of nicotine and quit smoking for good! . . . Our new program is designed to naturally and slowly wean your body off of the nicotine cravings by slowly decreasing them. . . . The Nicotine Withdrawal System consists of everything you need to decrease your nicotine cravings over a period of 3-6 months, depending on how quickly you'd like to accomplish your goal. . . .

E-cigarettes Reducing 400,000 American Deaths per year to 10,000. 

Experience better health without the toxins, tar and other poisons traditional cigarettes contain. Your body will notice the relief of cutting out all of those added poisons. Our customers tell us that they feel better, their skin is better looking and they breathe better.

The Electronic Cigarette or e-cigarette, is a patented sophisticated electronic device that atomizes purified liquid nicotine and produces a vapor that, when inhaled, satisfies a smoker's craving for nicotine . . . .

When using the E-cigarette, drawing on it produces the physiological effect that a smoker seeks . . . ."

These are perfect examples of what are therapeutic claims. Here, the company is claiming that the product will treat nicotine dependence, wean smokers off nicotine (i.e., treat nicotine addiction), reduce deaths, satisfy the physiologic need for nicotine, and affect the physiological function of the body. Both structure/function and disease claims are being made here.

This warning letter, therefore, is legitimate and is a proper interpretation of the FDCA. The question is: Why isn't the agency consistent in its interpretation of the Act? Why is it lumping together claims that are therapeutic claims with those which are not because they represent neither structure/function nor disease claims?

The rest of the story is that it is not clear to me that the FDA is using a consistent and proper interpretation of the FDCA definition of therapeutic claims with respect to statements being made by electronic cigarette companies. And as I discussed yesterday, the FDA now wants to codify this misinterpretation into a formal rule.

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