FDA WARNING_LETTER - CalmSupport.com, LLC

The FDA issued a Warning Letter to Ryan Donnelly regarding the product "CalmSupport," sold on www.calmsupport.com and www.vitaminsupport.com. The FDA reviewed these websites, the product label, and associated social media (Facebook, YouTube) and blogs (www.freefromhell.com, www.freefromhellblog.com) in December 2017.

The FDA determined that "CalmSupport" is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. This classification is based on numerous claims on the product label and websites indicating the product's intent for use in the cure, mitigation, treatment, or prevention of disease, specifically opiate withdrawal symptoms and addiction. Examples of such claims include "Opiate Withdrawal Aid Program," "Ease the symptoms of opiate withdrawal," and "help lessen the withdrawal symptoms related to opioid use."

As a new drug, "CalmSupport" requires prior FDA approval, which it lacks. Furthermore, it is misbranded because it is intended for conditions not amenable to self-diagnosis or treatment, making it impossible to provide adequate directions for layperson use.

The Federal Trade Commission (FTC) also reviewed the marketing claims for "CalmSupport" for potential violations of Sections 5 and 12 of the FTC Act, requiring competent and reliable scientific evidence for health-related claims. The FTC cited previous enforcement actions against similar products