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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GumRunner, LLC 8/22/13

 

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
5100 Paint Branch Parkway
College Park, MD 20740 

 

August 22, 2013
 
WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
 
Mr. Kevin Gass
President
GumRunners, LLC
333 Washington Street, FL 2
Jersey City, NJ 07302-3066
 
RE: 398518
 
Dear Mr. Gass:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.joltgum.com in June 2013 and has determined that you take orders there for the products Spearmint Jolt Energy Gum, Icy Mint Jolt Energy Gum, and Mint Flurry Energy Mints, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
On the “Info” page on your site regarding the benefits of caffeine in your products:
 
  • “Prevents Parkinson’s disease”
  • “Prevents skin cancer”
  • “Prevents dry-eye syndrome”
  •  “Helps control ADHD”
  • “Can help breathing in young babies”
  • “Curbs Depression”
 
Each of these is a link that directs the consumer to articles that also contain disease claims, including:
 
An article entitled “Jolt caffeine gum actually helps prevent Parkinson’s Disease”:
 
  • “It turns out caffeine helps prevent Parkinson’s. In a 30-year study … consumption of increasing amounts of coffee was associated with a lower risk of Parkinson’s.”
  •  “Chew some Jolt Gum a day and help keep the Parkinson’s away!”
  • “The caffeine in Jolt Energy Mints is a shield against Parkinson’s disease.”
 
An article entitled “150 days until summer. Stock up on Coppertone and Caffeine”:
 
  • “Turns out caffeine prevents skin cancer.”
  • “A new study from the Journal of Cancer Research shows that Caffeine and Coffee fanatics are less likely to develop the most common type of skin cancer.”
  • “The study … found those who drank three or more cups of coffee a day had a 20 percent lower risk of basal cell carcinoma than those who drank decaf.”
  • “We’re not 100% sure how why caffeine reduces the risk of cancer, but one theory is that ‘caffeine may help the body kill off damaged skin cells’ …”
 
An article entitled “Caffeine, and by extension, Jolt Gum, proven to reduce dry eye syndrome”:
 
  • “[D]ry eye [is] also known as keratoconjuctivitis sicca …. In a … study published in Ophthamology magazine … caffeine helped relieve dry eye!!”
 
An article entitled “Jolt Gum helps with … Look a Bird! Oh yes, helps with ADHD”:
 
  • “Caffeine helps in many ways … even helps prevent skin cancer.”
  • “Not a surprise that it helps you stay alert and concentrate. It’s that “stay alert and concentrate benefit” that helps people with ADHD.”
  • “[C]affeine is a molecular cousin of ritalin.”
  • “A bunch of scientists … did the usual control and placebo on some rats. They used some rats that were ADHD … and some that weren’t. Some rats received a dose of caffeine 30 minutes before training, others immediately afterwards, and others 30 minutes before a test session in a water maze. Pre-training caffeine improved the learning deficit in the “ADHD” rats … ‘These results demonstrate a selective learning deficit which can be attenuated by pre-training administration of caffeine,’ say the researchers.”
  • “So before you pop a Ritalin [sic], try a cup of Joe, chew some Jolt Gum, and eat some chocolate.”
 
An article entitled “Caffeine can actually help newborns who have trouble breathing”:
 
  • “There’s a whole lot of geeky science related to caffeine therapy … reducing ‘Apnea of Prematurity’ in premature infants less than a month old. ‘Apnea of Prematurity’ is a severe and dangerous condition …”
  • “For decades, doctors have prescribed caffeine to these premies because it improves their breathing …”
  • “In different studies involving thousands of newborns, those getting caffeine therapy were approximately 20% less likely to get BPD [bronchopulmonary dysplasia]. 
  • According to … the principal investigator in one of the studies … ‘It [caffeine therapy] definitely gives hope to parents. Of all the drugs we use in the neonatal intensive care unit, caffeine is the first to have been shown conclusively to reduce long-term disability in very preterm babies.’”
  • “Caffeine also reduced the rates of cerebral palsy and cognitive delay …”
 
An article entitled “Don’t worry. Be Happy. Chew Jolt.”:
 
  • “Besides just helping you to stay alert, according to a study … women who drank two to three cups of coffee a day reduced their risk of depression by 15 percent, compared to women who consumed only one cup of less per week.”
 
Furthermore, your News page states, “It’s not just you and we who think Jolt Gum is the magical elixir of life!,” Under this statement is a link to an article entitled “Men’s Health.” That article includes the following statement:
 
  • “[R]esearchers recently connected caffeine intake to a reduced risk of type-2 diabetes, and just last year, scientists … discovered that coffee may decrease a person’s chances of developing oral or esophageal cancer.”
 
In addition, when publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. The following are examples of publications that are used to market your product for disease treatment and prevention on your website, and are thus evidence of your product’s intended use as a drug:
 
  • “Fengju Song, Abrar A. Qureshi, and Jiali Han, Increased Caffeine Intake Is Associated with Reduced Risk of Basal Cell Carcinoma of the Skin, The Journal of Cancer Research,” accessed at www.cancerres.aacrjournals.org/content/72/13/3282 on 6/2/2013.
  • Coffee Drinkers Have Lower Risk of Overall Death, Study Shows” accessed at www.abcnews.go.com/health/coffee-drinkers-lower-risk-death-heart-disease-stroke/story?Id=16359526 on 6/2/2013.
  • Caffeine boosts breathing in premature infants”, NewScientist Health, by Roxanne Khamsi, 17 May 2006; Journal reference: New England Journal of Medicine (vol 354, p 2112), accessed at www.newscientist.com/article/dn9184-caffeine-boosts-breathing-in-premature-infants.html on 6/2/2013.
 
The claims listed above establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Based on these claims, your products are drugs within the meaning of section 201(g)(1)(B) of the Act. Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.   
 
Furthermore, your products Spearmint Jolt Energy Gum, Icy Mint Jolt Energy Gum, and Mint Flurry Energy Mints are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not meant to be an all-inclusive list of violations on your website or deficiencies in your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and any other labeling or promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in legal action without further notice, such as seizure or injunction.
 
Please notify this office, in writing, within 15 working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
 
Your written response should be directed to Aaron Dotson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), Division of Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions regarding this letter, please contact Aaron Dotson at 240-402-1922 or by email at Aaron.Dotson@fda.hhs.gov.
 
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition