FDA - Don't Represent Dietary Supplements As Foods

FDA: Dietary Supplements Can't be Marketed as Foods:

" . . . If nothing else, it is a very good reminder that you must be extremely careful making any representations about your product, not just the claims on the label," Prochnow said in an email Tuesday to the media. "Claims on websites and in other marketing and advertising can and will be used by FDA as evidence of the company's true intent to sell the product.""

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Dirty Medicine - A Fortune Feature - A Must Read!

This is a must-read . . .

Dirty medicine - Fortune Features:

"On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties -- the most ever levied against a generic-drug company."


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog


SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Sex Supplements - Containing Viagra; Other Issues

Sex supplements often contain Viagra ingredients | Reuters:

"Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.

Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Supplements Involved in Half of Drug Recalls

Supplements Involved in Half of Drug Recalls:

"Analysis of FDA data showed 51% of Class I recalls over a 9-year period involved adulterated dietary supplements instead of a pharmaceutical product, Ziv Harel, MD, of St. Michael's Hospital in Toronto, and colleagues reported in a Research Letter published online in JAMA Internal Medicine.

Most of those supplements were either sexual-enhancement, body-building, or weight-loss aids, they reported."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview

FDA Compliance and Enforcement; Inspection of Cosmetics: An Overview:

"Section 704 of the Federal Food, Drug, and Cosmetic Act (FD and C Act) authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.

A number of factors affect how FDA determines that an inspection of a cosmetic establishment may be warranted. These factors may include--but are not limited to--the type of products, the significance of consumer or trade complaints received, the company's compliance history, FDA surveillance and compliance initiatives, and agency resources.

Some things to know about inspections: . . . "

'via Blog this'

Follow the link above to read the full FDA article.

Although there are no good manufacturing practice (GMP) regulations for cosmetics, the FDA offers a Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog

Related articles

• FDA Audit Preparation (drughealth.blogspot.com)

FDA Targets Tainted Dietary Supplements

• FDA cGMP QSR GMP Online Training - popular cGMP online training classes offered by SkillsPlus International Inc.

Updated February 2, 2021:

You might recall, among the warnings and alerts recently issued, the FDA warned people to stop using Man Up Now, a product marketed for sexual enhancement, as it contains a variation of a drug ingredient found in Viagra that can lower blood pressure to a dangerous level.

The FDA intends to:

• Send a letter to the dietary supplement industry, stressing its legal obligation to prevent tainted products from reaching the market, and emphasizing the possibility of criminal investigations against those who endanger public health by their involvement in tainted products.
• Implement a new, rapid notification system for the public on the FDA web site to alert the public quickly to tainted products marketed as dietary supplements.
• Put in place a mechanism for industry to alert the FDA about the tainted products and the firms involved.

The FDA letter:  The FDA on Tainted Products Marketed as Dietary Supplements

Return Home: http://drughealth.blogspot.com/