VasoCorp, Inc.
FDA issued a warning letter to VasoCorp, Inc. (President William H. Cross III) regarding its dietary supplement products NeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula. The agency determined that website claims establish these products are intended to cure, mitigate, treat, or prevent disease (specifically neuropathy and nerve damage), making them unapproved new drugs under the FD&C Act. NeuropAWAY – Nerve Support Formula was additionally found to be misbranded for failing to bear adequate directions for use. FDA warned that failure to address violations may result in seizure or injunction.
Flagged claims (8)
R-Alpha Lipoic Acid (ALA) Protect nerves from damage…
You can find NeuropAWAY products in the diabetes section of major pharmacies across the country . . ..
Supports damaged and needy nerves.
NeuropAWAY targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…
NeuropAWAY burning, tingling, & numbness support.
Consumption of NeuropAWAY resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption.
NeuropAWAY Nerve Support 60 Daily Capsules Delivers Key Nutrients to Damaged & Inflamed Nerves.
NeuropAWAY Nerve Support Formula is a patented formula that is clinically proven to reduce the overall symptoms of occasional burning, tingling, and numbness by ~76%. NeuropAWAY's synergistic formula combines Taurine with other key ingredients to improve blood supply to damaged and needy nerves.
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.
If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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