NDAL Mfg Inc.
FDA issued a warning letter to NDAL Mfg Inc. (Monterey, CA) following a September 2021 inspection, citing significant CGMP violations and identifying three Manuka Honey nasal spray products as unapproved new drugs. The company's product labels and website made drug-intended-use claims — including treating sinus infections, supporting immune function, and clearing nasal passages — without FDA-approved applications. FDA also flagged inadequate quality control, failure to investigate microbial contamination, and lack of stability testing. The letter demands corrective actions within 15 working days and warns that failure to comply may result in seizure, injunction, or withholding of export certificates.
Flagged claims (8)
Ever since I use [sic] ManukaGuard Sinus Cleanser I am not picking up any of the viruses floating around during flu season.
After days i [sic] hardly have any post nasal drip for the first time in years.
Medical grade Manuka Honey supports a strong immune system, reduces irritation in the throat and soothes coughs associated with hoarseness, dry throat, environmental contaminants.
Breathe Easy
SUPPORTS CLEARING OF NASAL PASSAGES
Ingredients: Medical Grade Manuka Honey 16+ MGO 600…
Ingredients: Medical Grade Manuka Honey 12+ MGO 400…
I was in the beginning of a sinus infection. I did not want to take antibiotics again. ONE USE after I bought it sitting in the store parking lot. I am 90% better now and slept like a baby last night.
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
We acknowledge your commitment to temporarily suspend production of drugs for the U.S. market. If you plan to resume production of drugs for the U.S. market, notify this office before resuming your operations.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
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