Getting it Right on Spent Grains | FDA Voice

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Updated October 20, 2021

The original link broke.

You can still read about the same topic here:

FDA Issues Updated Spent Grain Rules - Beer Institute.org

---  the original post follows below  ---

Getting it Right on Spent Grains | FDA Voice:

"We've heard from trade groups and members of Congress, as well as individual breweries raising concerns that FDA might disrupt or even eliminate this practice by making brewers, distillers, and food manufacturers comply not only with human food safety requirements but also additional, redundant animal feed standards that would impose costs without adding value for food or feed safety.

That, of course, would not make common sense, and we're not going to do it.

In fact, we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it."

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FDA Seeks to Regulate e-Cigs, All Other Tobacco Products - Medscape

Updated Nov 11, 2015:

You might have been looking for:
Vape Regulation Is Coming, and It Just Might Kill the Industry

- - - original post follows below - - -

FDA Seeks to Regulate e-Cigs, All Other Tobacco Products - Medscape:

"The FDA initially announced its intention to assert jurisdiction over unregulated tobacco products back in 2010. In April 2011, the FDA announced its plans to include e-cigarettes among these products.

The new proposal would extend the FDA's basic authority to all other tobacco products beyond what it already regulates on the basis of the 2009 Family Smoking Prevention and Tobacco Control Act.

Currently, unregulated tobacco products include not only e-cigarettes but large and small cigars, as well as hookah and pipe tobacco, smokeless tobacco, and other tobacco products."

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Sun Pharmaceutical to Buy Ranbaxy in $3.2 Billion Deal - WSJ.com

Sun Pharmaceutical to Buy Ranbaxy in $3.2 Billion Deal - WSJ.com:

"The deal would make Sun Pharma the largest pharmaceutical company in India and the fifth-largest generic drug company in the world. But it would also saddle the Mumbai-based company with the chore of fixing up Ranbaxy's operations and ending restrictions on its U.S. sales.

Before curbs imposed by the U.S. Food and Drug Administration, Ranbaxy earned about 40% of its revenue from the American market. Now, only one Ranbaxy plant, located in the U.S., is producing drugs for U.S. consumption."

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What Should I Expect During An Inspection? - FDA Basics

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FDA Basics for Industry > What should I expect during an inspection?:

"FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions." . . .

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FDA Focusing On Food & Drug Manufacturing GMP Compliance

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Updated December 9, 2021

Links in the original post broke.

You might also like:

Current Good Manufacturing Practice (CGMP) Regulations - FDA.gov

Compliance & Enforcement (Food) - FDA.gov

---  the original post follows below  ---

FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

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On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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What Sequestration Means To The FDA - by FDA Matters

This is a good article that highlights what Sequestration means to the FDA.

Funding Cutbacks at FDA: A Sequester Primer « FDA Matters:

" . . .  If food is less safe…if drug and devices reviews go more slowly….if problems with imports increase….and if regulatory science and agency modernization stall….then there is a huge loss to the American people.

This loss is made larger by the knowledge that the agency’s mission is not static.  Congress has passed 6 new laws since 2009 giving FDA substantially more responsibility. Globalization and complex science makes the agency’s job larger and more difficult each year.

FDA staff wasn’t large enough to get the whole job done last year. Problems will  multiply quickly over the coming months as existing employees represent an every smaller proportion of the numbers needed to carry out this year’s and next year’s responsibilities."

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FDA and Tobacco Industry - The Tension & Next Steps

Updated 1/18/2016:
You might be interested in:
FDA's Smoking Prevention Campaigns: Reaching Teens Where They 'Live'

Updated 10/30/2015
You might've been looking for:
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FDA Acts to Shut Down Tobacco Sales at Stores That Sell to Minors

= = original post below = =

FDA's New Tobacco Scheme, and its Legislative Underpinnings, May Go Up in Smoke - Forbes:

"Several years ago, the federal government entered into a Faustian bargain with the tobacco industry — and the cigarette makers with the government. It was legislation borne of mutual antipathy.

Under the scheme, Washington brought the tobacco industry under the thumb of federal regulation. FDA now oversees everything from the way cigarettes are marketed, to the manner in which they are made. In exchange, the tobacco industry was promised a regulatory track out of their current (declining) business model.

FDA was to create a path to enable cigarette makers to transition away from smoked tobacco and win government approval of consumable products that used tobacco but presumably harbored less, and perhaps even none of the health risks posed by smoking. "

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Learn more about an upcoming March 2013 workshop:
FDA - Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

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FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

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Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

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FDA Facts About Current Good Manufacturing Practices (cGMPs)

If you're new to the FDA's cGMPs, then follow the link below, to their website. It explains what the cGMPs are all about:

Manufacturing > Facts About Current Good Manufacturing Practices (cGMPs):

"Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.  This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?" . . .

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IOM Suggests Other Alternatives To The Word "Counterfeit" re: Drugs

FDA Law Blog: Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs:

"IOM recommended excluding the use of the term “counterfeit.”  There is disagreement in the international regulatory community as to whether “counterfeit” refers broadly to something that is “not what it claims to be,” or whether the narrower, legal definition, which focuses on trademark infringement, is applicable.  The IOM report forgoes the use of the term “counterfeit,” and instead encourages the use of the terms “substandard,” “falsified,” and “unregistered.”  “Substandard” drugs are “those that do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier.” "

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FDA Seizes Illegal Dietary Supplements in FL

FDA Seizes Illegal Dietary Supplements in FL | Designated Representative and Exemptee:

"WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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ADA & FDA - Revised Recommendations for Dental X-Rays

English: Examples of dental radiography (Photo credit: Wikipedia)

X-Rays - American Dental Association - ADA.org:

"Guide to Patient Selection and Limiting Radiation Exposure

The ADA, in collaboration with the FDA, developed recommendations for dental radiographic examinations to serve as an adjunct to the dentist's professional judgment of how to best use diagnostic imaging. Radiographs can help the dental practitioner evaluate and definitively diagnose many oral diseases and conditions. "

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Reference:
Dental Radiographic Examinations: Recommendations for Patient Selection and Limiting Radiation Exposure (pdf)

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FDA on the Ranbaxy Atorvastatin Recall

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The FDA is providing additional related information. Just follow the link below.

Drug Safety and Availability > FDA Statement on the Ranbaxy Atorvastatin Recall:

"FDA Statement on the Ranbaxy Atorvastatin Recall

Update: 11/30/2012
FDA is notifying the public that after reviewing additional information related to the Ranbaxy atorvastatin recall, FDA has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low.

What patients should know . . . "

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FDA’s Top Supplement Issues

FDA’s Top Supplement Issues:

"Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, gave a quick talk this morning at SupplySide West, touching on FDA’s top regulatory concerns for supplements. He said the most important topic is good manufacturing practices (GMPs), but that’s not the only supplement issue that’s currently top of mind to FDA.

In short, Fabricant said these are the most pressing industry issues: . . ."

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A Regulatory App-ening - A mobile apps POV on FDA medical device regulations

Read this well-written point of view regarding the FDA's medical device regulations and how they impact mobile applications . . . are they or aren't they medical devices?!

Drugwonks | A Regulatory App-ening:

" . . . during the session on mobile apps as medical devices. At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” As Vice President Biden said, “It’s a big f**kin’ deal.”

But when is an app a medical device and when is it not? Not surprisingly, it depends."

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Compounding pharmacies need FDA oversight

Will Congress step in, to help the FDA?

Compounding pharmacies need FDA oversight - The Washington Post:

. . . Congress gave the FDA some oversight power in 1997 over compounding pharmacies, but several of the firms challenged the law in court. At issue was the FDA’s power to regulate their brochures and advertising. In 2002, the Supreme Court ruled for the pharmacies. Two appellate court decisions since then conflict about whether the original law is valid and enforceable. Congress has failed to clarify the situation. . .

"The federal government, Congress and the states all bear some blame for this lapse of oversight. There are proven methods to prevent contaminated medicine from reaching patients — methods that were simply not used in this case. Congress can remedy the situation by putting the regulation of large-scale drug compounding unequivocally under FDA control. The health and safety of Americans demand that government not fail a second time."

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FDA Statement on NECC Fungal Meningitis Outbreak: Additional Patient Notification Advised

Fda (Photo credit: Wikipedia)

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised:

"At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), "

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FDA approves first drug for reducing the risk of sexually acquired HIV infection

Updated June 19, 2025

The original post has gotten very out of date.

You might be interested in this more current announcement, Breakthrough: FDA Approves Injection to Prevent HIV:

https://www.sciencealert.com/breakthrough-fda-approves-injection-to-prevent-hiv

---  the original post follows below  ---

This is considered pivotal in the 30-year battle against AIDS.

Press Announcements > FDA approves first drug for reducing the risk of sexually acquired HIV infection:

"Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.

As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing."

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FDA - CBER Releases Strategic Plan for 2012-2016

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Just released, the FDA CBER Strategic Plan for Regulatory Science and Research

CBER Releases Strategic Plan for 2012-2016 Period - RAPS - News - Article View:

"CBER’s plan outlines six core strategic goals it says will guide it through the next five years:

1. Increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza and emerging infectious diseases
2. Improve global public health through international collaboration including research and information sharing
3. Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
4. Ensure the safety of biological products
5. Advance regulatory science and research
6. Manage for organizational excellence and accountability"

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• FDA Global Initiative (drughealth.blogspot.com)