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RESPONSE LETTER

Synaptent, LLC


Reference #:
FY22-HAFE-WL-01

Company:
Synaptent, LLC
Synaptent, LLC

1442 W. Fulton St.
Chicago, IL 60607
United States

18886796278
Recipient:
Lauren Crivellone
Compliance Officer

United States


Attention: Lauren Crivellone
Compliance Officer, U.S. Food and Drug Administration
Office of Human and Animal Food Operations – Div. East 6
550 W. Jackson Blvd Suite 1500
Chicago, IL 60661
Phone: (312) 596-4157

Re: Synaptent LLC (FEI 27-2205416) Warning Letter (FY22-HAFE6-WL-01) Response

Ms. Crivellone:

The Warning Letter was received on November 9th, 2021. This response is timely.

Synaptent LLC appreciates your bringing problematic claims on our www.liftmode.com website to our attention. Our firm is committed to full compliance with applicable regulations, and we shall remove or revise all the statements or claims identified in the warning letter that might be perceived to establish our firm’s products as “drugs” under 201(g)(1) of the Act [21 U.S.C. §321(g)(1)], “unapproved drugs” ” under section 201(p) of the Act [21 U.S.C. § 321(p)], or “misbranded drugs” under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. Corrections to the content on our site are ongoing and will be completed within the next 5 business days.

We believe the corrective actions we are taking to revise the content on our site should substantially satisfy the Agency's concerns about such claims. We further commit to ongoing review of existing and new claims and site content with legal counsel specializing in FDA compliance, and we anticipate ongoing regular review will mitigate risk of further reoccurrence. Upon initial review, a few potentially problematic phrases and images on our site beyond those mentioned in the Warning Letter have been identified and are also being revised or removed.

Synaptent LLC also acknowledges the failure of some of our product labeling to express product weight in terms of avoirdupois pound and ounce units as required by 21 CFR 101.7(b)(1) which may cause our supplement products to be misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]. We are revising all deficient product labeling to include product weights in the required measurement units within 10 business days and will ensure all respective product images and finished goods available for purchase reflect the corrected labels within 60 business days.

Pursuant to the Regulatory Procedures Manual § 4-1-8(2), we respectfully request this response be posted on the Agency's website, redacted as deemed necessary.

 

Kind Regards,

Armand Tuzel

Managing Member
Synaptent LLC

 
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