FDA Denies Authorization to Market JUUL Products - FDA.gov

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According to the news release:

"Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action." 

Read the full news release: FDA Denies Authorization to Market JUUL Products - FDA.gov

FDA’s Lax Enforcement Trend Continues - Pharma Marketing Blog

Read article & view chart: Pharma Marketing Blog: FDA’s Lax Enforcement Trend Continues:

"FDA continues to issue fewer and fewer warning and untitled letters. As of today (8 December 2016) FDA has issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015."

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Health Canada: We do not enforce the law when Canadians poison Americans - Searching for Safety

Read the full article: Health Canada: We do not enforce the law when Canadians poison Americans - Searching for Safety:

"Simply put, Health Canada admits that it does not intend to enforce the law on Canadian internet pharmacies that sell to foreigners.  We suspected this was the excuse, but now it’s official. As Health Canada’s response says:

Health Canada prioritizes its work according to the risk to health that the incident may pose to Canadians. Incidents that present a potentially higher risk to health will be actioned first. Incidents of low or nominal risk will be assessed and entered into our tracking system for possible future compliance action as deemed appropriate."

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Dietary Supplement Industry - Vulnerable to FDA Enforcement

Dietary Supplement Industry: Everyone Vulnerable to FDA Enforcement:

"Who is at risk in the dietary supplement industry from the enforcement arm of FDA?

The short answer, says veteran attorney Anthony Young, is everybody.

"We are no longer an unregulated industry in any way," declares Young, a partner with Kleinfeld, Kaplan and Becker, a firm concentrating on the regulation of products subject to FDA jurisdiction."

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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.

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2012 Crystal Ball Predicts a More Aggressive FDA

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Updated February 2, 2021

Links in the original post broke.

- - -  the original post follows below  - - -

2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "

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The article references:

The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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FDA Crackdown on Viagra-Like Supplements

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Updated November 12, 2020

Links broke in the original post.

You might also be interested in:  Tainted Sexual Enhancement Products - FDA.gov

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FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."

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My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.

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Surviving FDA Enforcement Actions - Free Tips

Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:

"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."

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Annual FDA Inspections Summit

• The best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

Updated June 5, 2025

The original link broke.

You might also be interested in the Annual FDA Inspections Summit:

https://wcg.swoogo.com/fda-inspections-vsummit

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Sixth Annual FDA Inspections Summit:  'via Blog this'

This caught my eye. I'm sharing it because I know that many of you have an interest in FDA inspections.  The Sixth Annual FDA Inspections Summit is scheduled for Tuesday, Oct. 4 - Thursday, Oct. 6, 2011, in Bethesda, MD.

With a quick Google search, the other large event seminar offering an FDA Inspection focus, was this seminar held earlier in the year:

ISPE - The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,”

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Learn From 2010 FDA Warnings To Pharma Companies

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2010 is now behind us.  It's time to turn your attention to 2011. If you're in the FDA GMP training space, consider leveraging the following resource in your GMP trainings:  FDA Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters.

From this main Warning Letters page, you can research and learn from the warning letters, that can be found by:

• Year
• Company
• Subject
• . . . and many other advanced search criteria

The Warning Letters can be used as great examples of just how important it is to comply with the regulations.

You might also be interested in:
Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

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FDA Promises Swift-Aggressive Enforcement To Protect Public Health

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The Food and Drug Administration (FDA) is articulating its enforcement strategy in order to ensure strategic alignment within the Agency and express why enforcement is critical to protecting public health. The FDA has the responsibility and authority to safeguard the public health and ensure compliance with the laws and regulations it administers pertaining to foods, drugs, medical devices, biologics, and tobacco products.

Enforcing the laws and regulations is one of the Agency’s highest priorities. The FDA is committed to swift, aggressive enforcement actions to protect the public health.

Under the FDA's scrutiny, it's important more than ever before that drug and device manufacturers have their house in order.  Getting a house in order also includes paying attention to executive and operator training around the FDA regulations, such as cGMP regulations and more.

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FDA - Impending 21 CFR Part 11 Inspections - Electronic Records

Get ready, here they come!

The FDA just announced, FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs, that they will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.

The guidance describes how FDA intends to exercise enforcement discretion and sets forth the following considerations related to Part 11:

• Part 11 remains in effect since the issuance of the guidance and the exercise of enforcement discretion applies as identified in the guidance.
• The guidance sets out certain conditions related to the validation, audit trail, record retention, record copying, and legacy systems where the Agency does not intend to take enforcement action to enforce compliance. Conversely, violations of part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation.
• Records must also be maintained or submitted in accordance with regulatory requirements outside of Part 11, and we will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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The ConsumerLab Red Yeast Rice Product Review - FDA Enforcement Policy

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If you take red yeast rice products, for cholesterol-lowering, then you need to read this post, "ConsumerLab Red Yeast Rice Product Review Creates Potential Safety and Regulatory Problems." It appears that ConsumerLab; Hyman, Phelps & McNamara, P.C.; and the FDA converge to make this a compelling read. As stated in a posted Hyman etal memo, "ConsumerLab.com Red Yeast Rice Product Review Is in Conflict with the Law and FDA Enforcement Policy, Creating Safety Issues for Consumers and Regulatory Issues for Industry," . . . "The ConsumerLab product review of red yeast rice supplements makes incorrect statements about the law and FDA enforcement policy, and creates general confusion about the marketing of red yeast rice products. Most important, the review encourages consumers to purchase dietary supplements with high levels of monacolins that FDA has determined to be unsafe."

I'm perpetually perplexed that these kind of situations continue to exist. There are FDA regulations, and companies are expected to comply with them. I care, because when the regs aren't followed, I as a consumer, might inadvertently pay the adverse consequence.

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