Warning letter · FDA Warning Letters, Historical Archive

CalmSupport.com, LLC: FDA Warning Letter 542734 (Jan 11, 2018)

Agency action: Jan 11, 2018Record ID: fda_warning_-b4d2fc22edef4c27
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What happened

Original notice title

CalmSupport.com, LLC MARCS-CMS 542734, January 11, 2018

From the archived source record

In addition, the Federal Trade Commission has reviewed your marketing claims for “CalmSupport” for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. This YouTube page links to your website, www.calmsupport.com, where your product can be purchased directly, and provides further evidence that your product is intended for use as a drug: In the YouTube video description: “CalmSupport Review: The Leading Home Remedy For Opiate Withdrawal” “…[T]he best opiate withdrawal aid on the market.” Additional claims observed on your website’s blog, www.calmsupport.com/blogs/news that provide evidence your product is intended for use as a drug, include the following: In an August 12 th post on Page 149, titled, “What Can I Expect Going Through Opiate Withdrawal”: “ … [W]e at CalmSupport.com are here to help you the natural way. 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). Accordingly, “CalmSupport” fails to bear adequate directions for its intended uses 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 misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. 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. 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, without limitation, seizure and/or injunction.

What the official notice says to do

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Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
053abd4a3f2c

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
CalmSupport; Opiate Withdrawal Aid Program; The Benefits of CalmSupport Opiate Withdraw; CalmSupport Review: The Leading Home Remedy For Opiate Withdrawal; About; Elimidrol; Withdrawal Ease; Recovery Ease
Company
CalmSupport.com, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.