Herbal Vitality, Inc.
FDA issued a warning letter to Herbal Vitality, Inc. (Sedona, AZ) after a July 2022 facility inspection revealed that 21 herbal supplement products — including formulas named for Lyme disease, Hepatitis C, COPD, PCOS, asthma, and kidney stones — were being marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The products were also found misbranded due to inadequate labeling, missing allergen declarations, and improper supplement facts formatting. Additionally, the company had significant CGMP violations including absent component specifications, no finished-product specifications, and failure to collect reserve samples. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (11)
The antifungal herbs assist the body in ridding fungal overgrowth in order to restore healthy flora balance.
…antispasmodic analgesic and demulcent, and aid in relief of renal and ureter spasm and inflammation.
The herbs [in this formula]…have anti-tumor properties.
The herbs in this formula are antimicrobial, alterative, analgesic and diaphoretic.
Adjunctives to cancer treatment
…the herbs bring their actions to respiratory and digestive tracts and help clear a fever. Anti-viral, diaphoretic, expectorant, antispasmodic, carminative…
Antimicrobial and lymphagogue herbs are combined with alternative, anodynal, and diaphoretic herbs to tonify mucous membranes and immune system, cleanse the tissues and clear heat.
…broad antimicrobial effects along with lymphagogue actions that cleanse the tissues and strengthen immunity. Diaphoretic herbs assist with fever management.
The herbs in this formula are…antiviral, expectorant, antispasmodic, alterative, carminative…
The herbs in this formula are antispasmodic bronchodilators. They are anti-inflammatory, expectorant, antimicrobial, demulcent…
A blend of herbs with antimicrobial, anti-inflammatory…actions…
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker