Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm504533.htm
Timestamp: 2019-04-26 08:03:37+00:00

Document:
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the information on your website, www.zxtbeepollenpills.com, and determined that you offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that certain products you offer for sale including, but not limited to, “Jenesis,” “Prime,” and “Propell Platinum” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)]. Furthermore, these products are misbranded drugs under sections 502 and 503 of the FD&C Act [21 U.S.C. §§ 352 and 353].
FDA confirmed through laboratory analysis that your “Jenesis,” “Prime,” and “Propell Platinum” contain undeclared sibutramine and phenolphthalein. 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. 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 “Jenesis,” “Prime,” and “Propell Platinum” 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, “Jenesis,” “Prime,” and “Propell Platinum,” which all contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.
In addition, your “Jenesis,” “Prime,” and “Propell Platinum” are new drugs under section 201(p) of the FD&C 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 FD&C Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There are no approved applications on file with FDA for your “Jenesis,” “Prime,” and “Propell Platinum.” The distribution or sale of “Jenesis,” “Prime,” and “Propell Platinum” in interstate commerce without such approved applications violates these provisions of the FD&C Act.
Your “Jenesis,” “Prime,” and “Propell Platinum” products also are 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 “Jenesis,” “Prime,” and “Propell Platinum” 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 “Jenesis,” “Prime,” and “Propell Platinum” fails to bear adequate directions for their intended uses. “Jenesis,” “Prime,” and “Propell Platinum” 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, “Jenesis,” “Prime,” and “Propell Platinum” 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 their sibutramine and phenolphthalein content, which are material facts with respect to consequences that may result from the use of these products. As described above, sibutramine and phenolphthalein may pose health risks to consumers which are only compounded by the fact that neither ingredient is declared on the labels.
“Jenesis,” “Prime,” and “Propell Platinum” also are 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, “Jenesis,” “Prime,” and “Propell Platinum” 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 drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
FDA also issued warnings to consumers not to use “Jenesis,” “Prime,” and “Propell Platinum” (see Jenesis Immediate Public Notification, Prime Immediate Public Notification, and Propell Platinum Public Notification).
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.
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].
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections. Please send your written response to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions with regard to this letter, please contact Randall Morris at Randall.Morris@fda.hhs.gov or by phone 407-475-4741.

References: § 321
 § 321
 § 352
 § 201
 § 352
 § 321
 § 352
 § 352
 §331