Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm354241.htm
Timestamp: 2017-09-26 09:06:05
Document Index: 678285495

Matched Legal Cases: ['§ 355', '§ 352', '§ 321', '§ 321', '§ 321', '§ 331', '§ 353', '§ 352', '§ 201', '§ 201', '§ 352', '§ 352', '§ 321', '§ 352', '§ 352', '§ 331']

Zi Xiu Tang Success, LLC 5/14/13
13-PHI-17
Jennifer Gehris, President and CEO
Kutztown, PA 19530-9043
Dear Ms. Gehris:
The U.S. Food and Drug Administration (FDA) conducted an inspection at your distribution center located at 177 Creek Road, Kutztown, PA, from October 18, 2012 to October 24, 2012. This letter concerns products that your firm distributes to consumers and other distributors. During the inspection noted above, FDA investigators collected samples and product labeling of products, including “Ultimate Formula Bee Pollen Capsules (Ultimate Formula)” and “Zi Xiu Tang Bee Pollen Capsules.” As described below, these products are unapproved new drugs under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 331(d)] and misbranded drugs in violation of section 502 of the Act [21 U.S.C. §§ 352].
Unapproved and Misbranded Prescription Drugs
You market “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” as dietary supplements. However, under section 201(ff)(3)(B)(ii) of the 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.
FDA confirmed through laboratory analyses that your “Ultimate Formula” (Lot # 05/25/2012 EXP. 05/24/2014) and “Zi Xiu Tang Bee Pollen Capsules” (Lot # 04/15/2012 EXP: 04/15/2014) contained undeclared sibutramine hydrochloride (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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on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.
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. Given that sibutramine was not marketed as a dietary supplement or as a food before Meridia was authorized for investigation as a new drug, your “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules,” which contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act.
Your “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” are 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)(B) and (C) of the Act [21 U.S.C. § 321(g)(1)(B) and (C)]. Labeling statements documenting the intended uses of these products include, but are not limited to the following:
“Your All Natural Weight Loss Solution”
“Ultimate Formula utilizes safe and all natural ingredients to . . . help men and woman lose weight, and inches . . ..”
“These natural ingredients . . . assist the body in suppressing the appetite, increasing energy and metabolism . . ..”
“Zi Xiu Tang Beauty, Face, and Figure Capsules . . . safely helped thousands of people reduce their weight.”
“[P]roduces visible results for those seeking safe alternative weight loss support.”
“Your natural weight loss solution”
“Classic Zi Xiu Tang Bee Pollen reshapes the body.”
“It eradicates fat out of the body. It can improve the human endocrinology and small vessels to change the figure of an overweight person.”
In addition, your “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules,” are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the 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. Your marketing and distribution of “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” without approved applications violates these provisions of the Act.
Furthermore, “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” are “prescription drugs” as define in section 503(b)(1)(A) of the Act [21 U.S.C § 353(b)(1)(A)], because, in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules,” which contain undeclared sibutramine, are prescription drugs 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. They are also prescription drugs because the FDA approval of Meridia was withdrawn because of serious safety risks.
Your above mentioned products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs 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 “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
Additionally, under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [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 products, “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” are misbranded under section 502(a) of the Act because their 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 labels.
“Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” are also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)], because the products’ labeling lack adequate warnings for the protection of users. As noted, there is potential for adverse events associate with the use of these products, particularly since someone who takes them would be unaware of the presence of sibutramine in these products.
Likewise, “Ultimate Formula” and “Zi Xiu Tang Bee Pollen Capsules” are misbranded under section 502(j) of the Act, [21 U.S.C. § 352(j)] because they are dangerous to health when used in the dosage or manner recommended in their labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not intended to be an all-inclusive list of violations at your facility and with your products, labels, and labeling. It is your responsibility to ensure that your products are in compliance with all applicable statutes and regulations, including the Act and federal regulations.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. Furthermore, it is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. 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 seizure, injunction, and/or prosecution. Furthermore, FDA may reinspect your facility to verify that corrective actions have been completed.
FDA acknowledges that you initiated a voluntary nationwide recall of four lots of “Zi Xiu Tang Bee Pollen Capsules,” with UPC Code 6937000700019 (Lot # 04/14/2012 EXP. 04/15/2014; Lot # 05/15/2012 EXP. 05/15/2014; Lot # 06/15/2012 EXP. 06/15/2014; and Lot # 07/15/2012 EXP. 07/15/2014); three lots of “Ultimate Formula” with UPC Code 793573041401 (Lot # 05/25/2012 EXP. 05/24/2014; Lot # 07/29/2012 EXP. 07/28/2014; and Lot # 08/05/2012 EXP. 08/04/2014) on October 22, 2012.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter and to prevent their recurrence. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections. You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA’s website at http://fda.gov/oc/industry.
Your response should be sent to Richard C. Cherry, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Mr. Cherry can be reached at 215-717-3075 or Richard.Cherry@fda.hhs.gov.
Attention: Dr. Lydia Johnson, Acting Director
Amber Krum, Co-Owner
Zi Xiu Tang Success, LLC - Close Out Letter 12/6/13