Inspections, Compliance, Enforcement, and Criminal Investigations

Belmora LLC 6/8/17

 

  

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Office of Human and Animal Food Operations Division East 2
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215
Telephone: 410- 779-5455
Fax: 410- 779-5705 

 

WARNING LETTER
CMS# 521015
 
VIA UNITED PARCEL SERVICE
 NEXT DAY DELIVERY
 
June 8, 2017
 
Jamie Belcastro, President and Founder
Belmora, LLC
2231 Crystal Drive
Unit 100
Arlington, VA 22202
 
Dear Mr. Belcastro:
 
This letter concerns your firm's marketing of the product Elavil OTC Sleep Aid. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address http://www.elavilotcsleep.com, where you promote and sell this product. Based on the labeling for your product and our review of your website, your Elavil OTC Sleep Aid is an unapproved new drug in violation of section 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331(d) and 355(a)]. Further, your product is also misbranded under section 502 of the Act [21 U.S.C. § 352]. As discussed further below, we have determined that your marketing of this product violates the Act. You may find the Act through links on FDA's website at http://www.fda.gov.
 
Unapproved New Drug
 
FDA reviewed your website at the Internet address http://www.elavilotcsleep.com in March 2017 and determined that you take orders there for the product Elavil OTC Sleep Aid. The claims on your website establish that the product is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims that provide evidence that your product is intended for use as a drug include:
  • “Just promoting drowsiness is solving only half of the insomnia problem…The other half of the insomnia problem is Stage 3 Sleep and REM Sleep, the deeper sleep your body needs to experience for you to wake up feeling refreshed…Elavil OTC Sleep is a complete solution to insomnia because it was formulated to work on all four stages of sleep.”
  • On the Sleep Disorders page, which includes the lines “Works during all four stages of sleep…Order Elavil OTC Now” and “Get more sleep with Elavil OTC Sleep…” you discuss “Acute Insomnia”, “Chronic Insomnia”, “Primary Insomnia”, and “Secondary Insomnia” ,“Works during all four stages of sleep…Order Elavil OTC Now…Sleep Apnea is a sleep disorder that leads to insomnia.”
  • On the Sleep Apnea Treatment page, it states “…sleep medicines or sleep aids that contain antihistamines such as diphenhydramine or doxylamine can make it harder for your body to breathe and take in sufficient oxygen. The sleep medicine Elavil OTC Sleep does not contain diphenhydramine or doxylamine or any anti-histamines.”
  • “Elavil prescription is a medicine containing amitriptyline. Amitriptyline belongs to a family of medicines called tricyclic antidepressants…also used to treat insomnia. Amitriptyline works to treat insomnia by promoting drowsiness or Stage 1 Sleep…Elavil OTC Sleep is a reformulation of Elavil prescription without amitriptyline that is sold as a nonprescription medicine in the U.S.”
  • On the Narcolepsy page, which includes the lines “Works during all four stages of sleep…Order Elavil OTC Now” it says “Remarkably, a great number of people who experience narcolepsy suffer from insomnia. Elavil OTC Sleep is a sleep aid that helps to induce and maintain sleep…”
  • “View Our Clinical Trail…Preliminary Results: Elavil OTC Sleep Survey Version 1.1, 02 November 2016…Results…Total Score After taking Elavil OTC…No insomnia 3, Sub-threshold insomnia 15,…100% of people used another sleep aid product before Elavil OTC Sleep…Over the counter medicine…Tylenol PM, Advil PM, Benadryl, Unisom…Prescription sleep medication i.e. Xanax, Ambien, Lunest…”
Your Elavil OTC Sleep Aid product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
Misbranded Drug
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your product Elavil OTC Sleep Aid is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Elavil OTC Sleep Aid product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
Further, 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. Use of the word “Elavil” in the labeling of “Elavil OTC Sleep” renders your product’s label misleading because your product may be confused with the proprietary and established name of “Elavil,” an FDA-approved prescription drug for the treatment of depression. See 21 CFR § 201.10(c)(5). Additionally, according to your website, “Elavil OTC Sleep” is misleadingly claimed to be a “reformulation” of prescription Elavil, when it is an entirely different product for a different indication. When taken as a substitute for appropriate treatment for depression, “Elavil OTC Sleep” may cause indirect harm by delaying the use of proven, beneficial treatments for patients suffering from depression. Your product “Elavil OTC Sleep” is therefore misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)]. The introduction or delivery for introduction into interstate commerce of this product violates sections 301(a) of the FDCA [21 U.S.C. § 331(a)]. It is also a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.
 
The above violations are not intended to be an all-inclusive list of violations that exist in connection with your products or their labeling. 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 all the products you manufacture or distribute meet all of the requirements of the Act and its implementing 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, such as seizure and/or injunction.
 
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Your written response should be sent to Compliance Officer CDR Rochelle B. Young, RPh, MSA at the address noted above. If you have any questions concerning this letter, please contact CDR Young via email at rochelle.young@fda.hhs.gov or telephone 410-779-5437. 
 
                                                                       
Sincerely,
/S/ 
Evelyn Bonnin
Program Division Director

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