Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centro-naturista-06162016
Timestamp: 2020-07-07 23:19:14
Document Index: 309641265

Matched Legal Cases: ['§ 355', '§ 352', '§ 321', '§ 321', '§ 321', '§ 321', '§ 331', '§ 352', '§ 201', '§ 201', '§ 352', '§ 321', '§ 352', '§ 331']

Centro Naturista - 06/16/2016 | FDA
Centro Naturista - 06/16/2016
Centro Naturista June 16, 2016
2016-DAL-WL-28
Rogelio Riojas Nieto, Owner
Dear Mr. Nieto:
The United States Food and Drug Administration (FDA) conducted a series of inspections of your own-label distribution facilities, Centro Naturista located at 14211 Coit Road, Suite H, Dallas, Texas 75254 and Smart Lipo 365 located at 2915 East Division Street, Suite 523, Arlington, Texas 76011. As described below, your Smart Lipo product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] as well as a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)].
FDA confirmed through laboratory analysis that your Smart Lipo product contains undeclared sibutramine and phenolphthalein.[1] 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.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 Smart Lipo as a dietary supplement. However, under section 201(ff)(3)(B)(ii) of the FD&C Act [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, Smart Lipo, which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(ii)].
Smart Lipo 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, is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)]. Labeling statements documenting these intended uses include, but are not limited to, the following:
“Burns Fat”
“Suppresses Appetite”
“Increase Metabolism”
In addition, Smart Lipo is a new drug under section 201(p) of the FD&C Act [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 FD&C Act [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 Smart Lipo without an approved application violates these provisions of the FD&C Act.
Smart Lipo is also misbranded under section 502(f)(1) of the FD&C Act [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]. It is impossible to write “adequate direction for use” for Smart Lipo for at least two reasons: 1) 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 and 2) FDA approval of Meridia was withdrawn because of serious safety risks. Smart Lipo is not exempt from the requirement that it bears adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because there is no FDA-approved application in effect for Smart Lipo.
Additionally, the failure to disclose the presence of sibutramine and phenolphthalein renders Smart Lipo misbranded under section 502(a) of the FD&C Act [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 FD&C Act [21 U.S.C. § 321(n)], provides that “[I]n 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 Smart Lipo is misbranded under section 502(a) of the FD&C Act because its labeling fails to reveal material facts with respect to consequences that may result from the use of these products. As described above, sibutramine and phenolphthalein may pose serious health risks to consumers which are only compounded by the fact that these ingredients are not declared on the label.
Likewise, Smart Lipo is misbranded under section 502(j) of the FD&C Act [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 FD&C Act [21 U.S.C. § 331(a)].
It is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and to comply with all requirements of federal law and regulations. [2]
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
[1] Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
[2] A list of tainted products discovered by FDA can be found at: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.