Inspections, Compliance, Enforcement, and Criminal Investigations

Descor LLC 8/19/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705 

Warning Letter
CMS#427813

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 19th, 2014
 

Ms. Tarra Desmond, Owner
Descor, LLC
Mailing Address: P.O. Box 4610
                             Parkersburg, WV 16104
 

Physical Address: 681 Red Hill Road
                               Parkersburg, WV 16104
 

Dear Ms. Desmond:

This letter concerns a product that your firm distributes to consumers and other distributors via your website, www.assetcapsules4u.com. The U.S. Food and Drug Administration has obtained a sample and product labeling of your product, "Asset Bee Pollen." As described below, this product is an unapproved new drug 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)] and a misbranded drug in violation of section 502 of the FD&C Act [21 U.S.C. § 352].

Unapproved and Misbranded Prescription Drug

FDA confirmed through laboratory analyses that a sample of "Asset Bee Pollen" contained undeclared sibutramine. The label for this product included your business, Descor, LLC. 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. In addition, previous samples of"Asset Extreme," "Asset Extreme Plus" and "Asset Bold," all which bear your company name on the label, were found through FDA laboratory analysis to contain sibutramine.

You currently market "Asset Bee Pollen" 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, "Asset Bee Pollen," which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.

"Asset Bee Pollen" is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] because it 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. Labeling statements documenting these intended uses include, but are not limited to, the following:
 

  • "Asset is an all-natural dietary supplement taken for weight loss, increased energy as well as to speed up your metabolism."
     

In addition, "Asset Bee Pollen" is a new drug under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because the 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. The distribution or sale of "Asset Bee Pollen" without an approved application violates these provisions of the FD&C Act.

"Asset Bee Pollen" 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 C.F.R. § 201.5]. It is impossible to write "adequate directions for use" for "Asset Bee Pollen" 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 "Asset Bee Pollen" fails to bear adequate directions for its intended use. "Asset Bee Pollen" is not exempt from the requirement that its labeling bears adequate directions for use under 21 C.F.R. § 201.100(c)(2) and 201.115 because no FDA-approved application is in effect for this product.

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 product, "Asset Bee Pollen," is 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 label.

Likewise, "Asset Bee Pollen" is misbranded under section 502(j) of the FD&C Act, [21 U.S.C. § 352(j)] because the product 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. § 33l(a)].

A full list of all tainted products discovered by FDA can be found at: http://www.accessdata.fda.gov/scripts/sdalsdNavigation.cfm?sd=tainted_supplements_cder

It is your responsibility under the FD&C Act 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., "all 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 FD&C Act 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 FD&C Act.

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 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 correction has been achieved. Additionally, if another or additional firm manufactures the products 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, David P. Rice, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions with regard to this letter, please contact Mr. Rice at 410-779-5463 or email david.rice@fda.hhs.gov.
 

Sincerely,
/S/
Randy Pack
Acting District Director
 

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