Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm367896.htm
Timestamp: 2019-04-23 06:28:23+00:00

Document:
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.
“In different studies involving thousands of newborns, those getting caffeine therapy were approximately 20% less likely to get BPD [bronchopulmonary dysplasia].
“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.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331