FDA issues warning to Utah company over unapproved Lyme disease product
Results RNA, LLC of Orem, UT was issued a warning letter from the Food and Drug Administration (FDA) last month over a number of unapproved/misbranded new drugs sold, including one for Lyme disease, where serious violations of the Federal Food, Drug, and Cosmetic Act were found.
The Lyme disease product, Ultimate Lyme Support Extra Strength, a combination product, was among many the FDA discussed in the letter.
According to the Results RNA website and product labels, this product:
- “ACS 200 Extra Strength…Broad-spectrum Antimicrobial…ACS 200 Extra Strength achieves 99.9999% (complete) kill against Borrelia burgdorferi, Bartonella henselae and co-infection microorganisms Powassan virus, MRSA and more without harming healthy flora or damaging human tissue. Results are fast acting and safe and recommended by Lyme literate doctors worldwide . . .”
- “ACZ Nano Extra Strength…Maximum Detoxification…Pathogens such as Lyme associated Borrelia burgdorferi require a toxic host to survive. Boost your immune system and achieve long term health by cleansing your body of immunocompromizing toxic heavy metals and more . . .”
- “ACN Neuro Extra Strength…Neurological System Rejuvenation…ACN Neuro Extra Strength effectively reduces neurological manifestations associated with Lyme disease. . .”
- “I was diagnosed almost 5 years ago with Lyme . . . I have only had 2 months of treatment and can tell a significant difference in the way I feel . . .”
- “A powerful oral detoxification agent, ACZ nano selectively and irreversibly binds and excretes toxic heavy metals, such as Mercury and Lead, chemical toxins, radioactive toxins and free radicals via the urinary tract . . . These results have been verified in multiple, independent urine challenge studies. Removing damaging toxins is vital for Lyme sufferers if health is to be restored . . .”
- “[H]eals and rejuvenates while minimizing herxheimer reaction . . . Kills Borrelia burgdorferi . . . Kills Bartonella hensalae . . . Proven to kill disease causing microorganisms . . . Detoxifies the entire body . . .”
Other products mentioned in the letter were marketed for MRSA and other pathogens.
See the full letter HERE
The FDA, based on the claims on the website and product labels, establish that the aforementioned products are drugs because they are used in the “cure, mitigation, treatment, or prevention of disease.”
RNA Results is to notify the FDA within 15 working days as to the specific steps they’ve taken to amend the violations.