We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » U.S. Attorney Sues Herbal Drugmaker Over Unapproved Drugs

U.S. Attorney Sues Herbal Drugmaker Over Unapproved Drugs

July 6, 2018

The U.S. Attorney for the Southern District of New York filed a lawsuit against an herbal drug manufacturer for selling unapproved drugs using claims that they can cure or prevent conditions including diabetes, syphilis, arthritis, cancer, heart disease and asthma.

The complaint accuses Rahsan A. Hakim and Adoniiah A. Rahsan, doing business as Sundial Herbal Products, of manufacturing and selling misbranded and unapproved drugs. None of the products were approved for their claims by the FDA and the manufacturers could not guarantee their identity, purity, strength or composition.

The defendants were the subject of multiple FDA inspections and failed to correct the violations. Many of the drugs were considered misbranded because the labeling did not include sufficient directions for use and the drugs did not qualify for an exemption from the labeling requirement. The defendants also illegally introduced or delivered misbranded drugs into interstate commerce, according to the complaint submitted by U.S. Attorney Geoffrey S. Berman.

View today's stories

Drugs Regulatory Affairs

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • GrayMatters Health’s Digital Therapy Device for PTSD Cleared

  • Dupixent Shows Positive Results in COPD Study

  • Advamedica’s Hemostat Cleared for Severe Surgical Bleeding

  • FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing