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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
October 15, 2014
Raul Lopez, Jr., Owner
Citrus Fit Weight Loss and Detox Products, LLC
Dear Mr. Lopez:
The U.S. Food and Drug Administration (FDA) has reviewed your website, www.citrusfit.com, and collected samples of your “Citrus Fit Gold” product. As described below, your “Citrus Fit Gold” is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a) and 331(d)] and a misbranded drug sold in violation of sections 502 and 301(a) of the FDCA [21 U.S.C. §§ 352 and 331(a)].
Unapproved New Drugs
FDA confirmed through laboratory analysis that your “Citrus Fit Gold” product contains undeclared sibutramine. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
You market “Citrus Fit Gold” as a dietary supplement. However, under section 201(ff)(3)(B)(ii) of the FDCA [21 U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug.
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of sibutramine became public. Based on the information available to FDA, sibutramine was not marketed as a dietary supplement or as a food until after it was authorized for investigation as a new drug. Therefore, “Citrus Fit Gold,” which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FDCA.
“Citrus Fit Gold” is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1) of the FDCA [21 U.S.C. § 321(g)(1)]. Labeling statements documenting these intended uses include, but are not limited to, the following:
- “[B]ody fat remover”
- “[L]ose weight quickly”
- “A person taking Citrus Fit can eat what they want and instead of absorbing the fat from their food, it will be excreted directly out of the body.”
- “Citrus Fit restrains the activity of lipase in stomach and intestinal canal to enable the fat in the food not to be absorbed by the body.”
In addition, “Citrus Fit Gold” is a new drug under section 201(p) of the FDCA [21 U.S.C. § 321(p)] because this product is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the FDCA [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Consequently, your marketing and distribution of “Citrus Fit Gold” without an approved application violates these provisions of the FDCA.
Furthermore, “Citrus Fit Gold” is a “prescription drug” as define in section 503(b)(1)(A) of the FDCA [21 U.S.C § 353(b)(1)(A)], because, in light of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. “Citrus Fit Gold,” which contains undeclared sibutramine, is a prescription drug because prior to withdrawal of Meridia’s approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs. It is also a prescription drug because the FDA approval of Meridia was withdrawn because of serious safety risks.
“Citrus Fit Gold” is also misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] in that the labeling for this drug fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can be used safely only at the direction and under the supervision of a licensed practitioner. Therefore, it is not viable to write “adequate direction for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because there is no FDA-approved application for your firm’s “Citrus Fit Gold,” its labeling fails to bear adequate directions for its intended use(s), causing it to be misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)].
Additionally, “Citrus Fit Gold” is misbranded under section 502(a) of the FDCA [21 U.S.C. § 352(a)], which states that a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FDCA [21 U.S.C. § 321(n)], provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . ..” Your product, “Citrus Fit Gold” is misbranded under section 502(a) of the FDCA because its labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of these products. As described above, sibutramine may pose serious health risks to consumers which are only compounded by the fact that sibutramine is not declared on the label.
Likewise, “Citrus Fit Gold” is misbranded under section 502(j) of the FDCA, [21 U.S.C. § 352(j)] because it is dangerous to health when used in the dosage or manner recommended in its labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke.
The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the FDCA [21 U.S.C. § 331(a)].
It is your responsibility under the FDCA to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law and regulations. In general, products marketed as dietary supplements that contain the ingredients sibutramine or their analogs are illegal because they are unapproved new drugs under 21 U.S.C. §§ 321(p) and 355(a) and/or adulterated dietary supplements under 21 U.S.C. § 342. When such products contain undeclared ingredients or bear misleading claims (e.g., “100% natural” or misrepresentations about the safety of the product), they are also misbranded drugs under 21 U.S.C. § 352 and/or misbranded dietary supplements under 21 U.S.C. § 343.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the FDCA and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the FDCA.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The FDCA authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 USC §§ 332 and 334].
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S. Food and Drug Administration, Jeff R. Wooley, Compliance Officer, Food and Drug Administration, Dallas District Office, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions with regard to this letter, please contact Jeff R. Wooley, Compliance Officer at 214-253-5251.
Reynaldo R. Rodriguez, Jr.
Dallas District Director