WARNING LETTER
NeuroHydrate LLC
MARCS-CMS 613092 —
April 27, 2021
Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Mr. Hamid Sami
Recipient Title
Founding Partner
NeuroHydrate LLC
4637 Main St, Unit 5
Bridgeport
,
CT
06606-1838
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
WARNING LETTER
CMS# 613092
Mr. Justin Higgins, Managing Partner
Dear Mr. Sami and Mr. Higgins:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://neurohydrate.com/ On January 2021 and has determined that you take orders there for the product “HM-FORMULA”. The claims on your website establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1) (B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
? The product description pages for your “HM-FORMULA” product state:
o “NeuroHydrate’s HM-Formula is…specifically designed for Headache and Migraine prevention.”
o “NeuroHydrate’s HM-Formula is…designed to reduce the frequency, severity and duration of headache and migraine”
? The frequently asked questions (FAQs) page of your webpage under the question “What is HMFormula?” states:
o “HM-Formula (Headache Migraine Formula) is…designed to prevent headache and migraine…”
o “The ingredients…were selected based upon their medical efficacy in headache and migraine prevention…”
? The HM-Formula product reviews page of your webpage:
o In response to a customer review dated May 30, 2019, your firm responded, “…HMFormula… contains a combination of proven…high-potency migraine prevention ingredients...”
o In response to a customer review dated January 08, 2018, your firm responded, “Our research and development is solely with the migraine prevention ingredients…used in the NeuroHydrate’s HM-Formula and their effect on chronic and frequent episodic migraine patients over time.”
o In response to a customer review dated August 01, 2016, your firm responded, “…we made a superior migraine prevention product....”
o In response to a customer review dated July 26, 2016, your firm responded, “We encourage you to compare HM-Formula’s ingredient label to other migraine prevention products.”
o A customer review dated December 7, 2020, states, “I have struggled with migraines my entire life…” to which your firm responded, “It is fantastic that NeuroHydrate’s MPT Program is working well for you…”
? The MPT Program page of your webpage which includes a 90-day supply of your HM-Formula product states, “…our Migraine Prevention Therapy Program (MPT)…”
? The HM-Formula product Quality of Life Customer Survey page of your webpage states:
o “NeuroHydrate created HM-Formula (HMF), a new migraine supplement…”
o “The underlying raw ingredients used in HM-Formula are…proven effective for migraine prevention…”
o “The first objective was to measure patients “before and after” migraine experience using HM-Formula. Customers reported a 25% pain scale improvement…”
o “NeuroHydrate believes that if migraine prevention supplements…are effective in migraine prevention…”
? The ingredients clinical studies and research and development page of your webpage states, “…consider using NeuroHydrate’s HM-Formula in first step migraine prevention.”
? The NeuroHydrate Core Ingredients page of your webpage states:
o “Randomized double-blind clinical trials demonstrated that a daily dose of 200 milligrams of Riboflavin is superior in preventing migraine…”
o “In a double-blind trial, 50 milligrams per day of B6 was effective in decreasing premenstrual depression…and is used for the prevention of nausea in migraineurs…”
o “In a randomized clinical trial, 300 milligrams per day of CoQ10 reduced the frequency of migraine by more than 50% in nearly half of all the participants…”
o “In two placebo-controlled studies, Omega-3 fatty acids performed significantly better than placebo in reducing headache frequency and intensity. In another double-blind study, with 27 medically diagnosed adolescents suffering from migraine, use of Omega 3’s showed marked improvement in reducing headache frequency, duration, and severity…”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
The matters cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the matters cited in this letter. Failure to promptly correct these matters may result in legal action without further notice, including, without limitation, seizure and injunction.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
Please send your reply to the U.S. Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, 1 Winners Circle, Suite 140, Albany, NY 12205 or by e-mail (preferred) to scott.izyk@fda.hhs.gov.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
05/18/2021
Regulated Product(s)
Drugs