Warning letter · FDA Warning Letters

Soda Pharm: FDA Warning Letter 626261 (Mar 10, 2022)

Agency action: Mar 10, 2022Record ID: fda_warning_-62c8d1315806e1e6
View official source ↗

What happened

Original notice title

Soda Pharm MARCS-CMS 626261, March 10, 2022

From the archived source record

the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address [see original source] on February 7, 2022, and March 8, 2022, respectively. We also reviewed your social media websites at [see original source] and [see original source] where you direct consumers to your website, [see original source] to purchase your products. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Some examples of the claims on your website and your social media websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include: • “Practical Advice For Managing Covid-19 at Home Over the past week, I’ve had a number of calls, emails and texts from people who are sick and need advice while managing covid at home. Above all else, it is important to avoid over-the-counter remedies like Tylenol. . [sic] they will block your body’s ability to clear the virus and contribute to a lengthening of your illness and symptoms. . [sic] or worse- contribute to an autoimmune disease.” [from your webpage [see original source] • “Which Cough Do You Cough. . . and How Do You Make It Stop? . . . This is by far one of my favorite weapons in my arsenal against an unproductive cough.” [from your webpage [see original source] • “Mullein Leaves are Cryptonite [sic] to Congestion . . .

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
5ef2f39fa03e

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.

Sources, dates, and coverage →

What is affected

Product
Cold and Congestion Loose Leaf Tea; Goldenseal Extract; Pain Release Extract; Headache Blend Extract; Vapor Balm; Mustard Plaster; Covid
Company
Soda Pharm
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.