| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
May 21, 2015
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Tiffany R. Smith, Owner
Akron ZXT Bee Pollen
924 E. Tallmadge Avenue
Akron, OH 44310
Dear Ms. Smith:
This letter concerns products that your firm distributes to consumers via your website, www.akronbeepollen.com, and via potential other retail outlets including, but not limited to, TNT Bootcamp, 924 E. Tallmadge Avenue, Akron, Ohio. The U.S. Food and Drug Administration (FDA) obtained samples and labeling of your products, “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin.” As described below, these products are unapproved new drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and misbranded drugs 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 samples of your “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” contain 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. FDA also confirmed through laboratory analyses that your “Zi Xiu Tang Bee Pollen Capsule” contains undeclared phenolphthalein. 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.
You market “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” as dietary supplements. 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 it was authorized for investigation 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, “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin,” which both contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.
Your “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)]. Labeling statements documenting the intended uses include, but are not limited to, the following:
Zi Xiu Tang Bee Pollen Capsule
- “This unique product makes it easy to lose fat and regain your figure with just two capsules a day.”
- “[R]apid weight loss without adhering to a strict diet . . ..”
- “[R]eshaping the body . . . reduces fat from the waist, abdomen, buttocks, and neck, but also effectively improves the waist-to-hip ratio . . ..”
From your promotional literature:
- “Promotes rapid weight loss & fat reduction”
- “Suppresses appetite & reduces cellulite”
- “Lowers cholesterol & blood sugar”
- “Alleviates allergies & boosts immunity”
In addition, your “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” are new drugs under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they 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 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. Your marketing and distribution of “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” without approved applications violates these provisions of the FD&C Act.
“Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” are also misbranded under section 502(f)(1) of the FD&C 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]. It is impossible to write “adequate directions for use” for “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” 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. As such, the labeling of “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” fails to bear adequate directions for their intended uses. “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” are not exempt from the requirement that their labeling bear adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved applications are in effect for these products.
Additionally, under section 502(a) of the FD&C 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 FD&C 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, “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin,” are misbranded under section 502(a) of the FD&C 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.
“Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” are also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because the products’ labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of these products, particularly since someone who takes them would be unaware of the presence of the undeclared ingredients.
Likewise, “Zi Xiu Tang Bee Pollen Capsule” and “Bee Thin” are misbranded under section 502(j) of the FD&C Act, [21 U.S.C. § 352(j)], because they are dangerous to health when used in the dosage or manner recommended in the 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 FD&C Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist with your firm’s products. Please note that FDA has not conducted a complete review of your inventory. A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder
. 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. It is your responsibility to ensure that products marketed by your firm comply with all requirements of federal law and FDA regulations. We advise you to review your websites, 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 FD&C Act.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice. The FD&C Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 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 corrections have been achieved. Furthermore, if another or additional firm manufactures the product identified above, your reply should include the name and address of 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, Elizabeth P. Kinsella, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions with regard to this letter, please contact Compliance Officer Kinsella at 513.246.4134 x1106 or email@example.com.
Douglas T. Heitkemper
Acting District Director