HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Another 'Rhino' Marketer Horned By US FDA About ED-Spiked Supplements

Executive Summary

Warning letter says Empire Distributors sold product branded “Rhino Black 5K Plus” that FDA analysis found contained sildenafil and tadalafil. FDA officials found on its websites, including an Amazon.com storefront, supplements bearing others brands used for products previously found with ED ingredients, including "Black Mamba Premium,” “Libigrow,” ““Rhino 25K,” and “Stamina-Rx.”

You may also be interested in...



US Supplement Market Regulation: Depression Claim, Undisclosed Drug, COVID Tincture

FDA warns 10 businesses they’re marketing unapproved and misbranded drugs by making claims for supplements to treat depression. Supplement also found with one of, if not the most common violations in the US supplement market: it contained an undisclosed ED drug.

HBW Regulatory Roundup: Spiked 'Vitamin C' Found, SC Johnson Facility GMP Problems, AHPA Labeling Guidance

Fitoterapia USA recalls 190,000 bottles of Metro Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement tainted with tadalafil; FDA sends GMP warning letter to SC Johnson facility making antimicrobial hand soaps ; and AHPA revises its herbal supplement labeling guidance.

NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA

FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134420

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel