Retail Sales of Tobacco Products - FDA.gov

• FDA cGMP QSR GMP online training courses by SkillsPlus Intl Inc.

Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note:
On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

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FDA Conducts Anticipated Hearing on the Regulation of CBD Products - FrierLevitt.com

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

Read the full article:  FDA Conducts Anticipated Hearing on the Regulation of CBD Products - FrierLevitt.com

"At the hearing, Acting Commissioner Dr. Ned Sharpless delivered opening remarks and reiterated that recent changes to federal and state law, and the explosion of CBD products in the marketplace, have not affected FDA’s view that CBD cannot be lawfully added to any FDA-regulated consumer product. While the Agriculture Improvement Act of 2018 (the “Farm Bill”) generally legalized CBD derived from hemp (defined as cannabis with THC content below 0.3% by dry weight), the Farm Bill explicitly preserved FDA’s authority to regulate foods, drugs, dietary supplements and cosmetics containing CBD."

Still more to follow, as the entire country holds its breath on personal use and big business making huge money investments and gambles.

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F.D.A. tackling C.B.D. in food - Food Business News

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Read the full article:   F.D.A. tackling C.B.D. in food - Food Business News

"Stakeholders in the manufacture, distribution, use and regulation of products containing cannabis or cannabis-derived compounds, such as cannabidiol (C.B.D.), had their say before a panel of Food and Drug Administration officials during a daylong public hearing held May 31 at the agency’s White Oak Campus in Silver Spring, Md. More than 400 individuals and associations applied to address the panel; more than 100 were able to do so."

According to "Amy Abernethy, Ph.D., the F.D.A.’s deputy commissioner ... “Key questions about product safety need to be addressed. Data are needed to determine the safety thresholds for C.B.D … There are both positive supporters of cannabis and cannabis-derived products including C.B.D. and also concerned citizens worried that widely available products can be harmful.”"

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Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence

Look into this crystal ball:  Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence:

"First the 21st Century Cures Act passes, weakening the FDA. Next, we’ll very likely end up with either a batshit nutty libertarian who doesn’t believe the FDA should require evidence of efficacy before approving drugs or a real, honest-to-goodness pharma shill as the next commissioner of the FDA. It’s going to be a long four years."

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3D-Printed Medical Devices Spark FDA Evaluation | LiveScience

3D-Printed Medical Devices Spark FDA Evaluation | LiveScience:

"The FDA currently treats 3D-printed devices the same way it treats conventionally made medical devices, an FDA spokeswoman said.

"We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used," spokeswoman Susan Laine told LiveScience in an email. She added, "In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device." "

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FDA - 70% of Supplement Companies Violate Rules

• People also search 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
  

FDA official: 70% of supplement companies violate agency rules:

"About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.

Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown."

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FDA Draft Guidance - Mobile Medical Apps - Practical Insights

A quick and insightful perspective on the much anticipated mobile medical app guidance . . .

Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:

"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."

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FDA - Mobile Medical App Guidance - Will it be delayed?

Final days of waiting for FDA mobile medical app guidance? | mobihealthnews:

"Now, on the eve of the FDA’s publication of the final guidelines, the Bipartisan Policy Center and companies that include McKesson, Microsoft, Oracle, athenahealth, Epocrates, Siemens, UnitedHealth Group, Teladoc, the Silicon Valley Chapter of Health 2.0 and StartUp Health have asked HHS to delay the FDA’s final guidelines on mobile medical apps until the workgroup [FDASIA workgroup] finishes."

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Food Companies Must Prep For FDA & FSMA

FDA’s Changing Culture: What Every Food Company Needs to Know - Food Safety Magazine:

"Implications for Food Companies - Thus, FDA has demonstrated increased or renewed interest in using a number of its enforcement tools, including inspections, Import Alerts, Warning Letters, actions for injunction and criminal liability under the Park doctrine. FSMA requires FDA to conduct more frequent inspections and gives it authorities for mandatory recalls and suspension of registration. Clearly, companies must recognize and adjust to FDA’s changing culture."

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Medical Device Tax Repeal Applauded

Medical Device Manufacturing Coalition Applauds Passage of Medical Device Tax Repeal Amendment | MedicalDevices.org:

"“Today’s overwhelming support of the amendment shows that clear majorities in the Senate and the House of Representatives recognize that the medical device tax needs to be repealed so that America’s medical technology community can spur growth and create the great jobs that come along with it,” said Mark Leahey, President and CEO of MDMA. “Every day innovators in this dynamic industry are looking at how to improve the quality of life for patients, and the medical device tax is standing in the way of progress and threatening America’s leadership position. While we have more work to do, MDMA applauds this important step towards ensuring that the United States remains the global leader in medical technology innovation.”"

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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:
E-cig firms steel for legal battle
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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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 - Two Proposed Rules Released to Implement FSMA

Updated October 15, 2016

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What to Expect Now that the First Big FSMA Compliance Dates Are Here

- -  original post follows below  - -

FDA Law Blog: On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules:

"FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."

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FDA - Food Facility Registration Renewal Deadline Extended - Guidances

Updated Mar 16, 2016

You might have been looking for:
Majority of FDA-registered food facilities now outside the U.S. - Food Safety News

- - -  original post below  - - -

FDA Extends Food Facility Registration Renewal Deadline And Issues Guidance Documents - Food, Drugs, Healthcare and Life Sciences - United States:

"The FDA recently announced that it will defer enforcement of the deadline for the biennial food facility registration renewal from Dec. 31, 2012 until Jan. 31, 2013. The action results from the FDA's delay in opening the registration renewal process from Oct. 1 until Oct. 22, 2013. The FDA is encouraging companies to complete the process early."

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Additional FDA Guidance Documents:
These answer basic questions about the food facility registration process.

• FDA Guidance for Industry: What You Need To Know About Registration of Food Facilities - Small Entity Compliance Guide
• FDA Guidance for Industry: Questions and Answers Regarding Food Facility Registration (6th Ed.)

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FDA Exerts FSMA Authority - Food Safety

Updated June 24, 2024

The original link broke.

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New Era of Smarter Food Safety - FDA.gov

---  the original post follows below  ---

FDA Writing New Chapters in Food Safety History | FDA Voice:

"With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce.

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. "

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Food Safety Regulations Backlog Affects FDA and USDA

Backlog for Food Safety Regulations Includes Both FDA and USDA | Food Safety News:

"Everyone knows about the food safety rules held up by “oh-eye-rah,” or as it is formally known at the White House, the Office of Information and Regulatory Affairs (OIRA). But it’s not just the U.S. Food and Drug Administration (FDA) that is waiting; the U.S. Department of Agriculture (USDA) also has food safety rules on hold too.

OIRA – the executive branch’s regulatory referee – has recently turned into a  bottleneck for the rules FDA needs to implement the new Food Safety Modernization Act.  The Act has been the subject of a lot of attention and, in recent months, even a lawsuit. A USDA rule requiring meat businesses to improve grinding logs and inventories, however, has gone relatively unnoticed, but this law is also held up by the powerful little White House office."

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Related articles

• FDA Increases Winery Inspections (drughealth.blogspot.com)

FDA and Supplement Regulations

Updated 11/7/2015:

You might have been looking for these:

Death By Dietary Supplement (Forbes) - Lamar Odom, etc.

USP launches new GMP audit certification program

By Stephen DANIELLS, 03-Nov-2015
There’s a new player in the GMP audit sector, with the United States Pharmacopeial Convention (USP) expanding its verification services to include a new GMP audit program for dietary supplement and dietary ingredient manufacturers.

= = = original post below = = =

This Slate article is an interesting read about the proliferation of dietary supplements, and the interest in tighter regulatory oversight.

Herbal supplement dangers: FDA does not regulate supplements and they can be deadly. - Slate Magazine:

"Between 1994 and 2008, the number of dietary supplement products on the market increased from 4,000 to 75,000. In the first 10 months of 2008, the FDA received nearly 600 reports of serious adverse events (including hospitalization, disability, and death) from these products and 350 reports of moderate or mild adverse events. However, the FDA believes that these reports are drastically underreported and estimates that the annual number of all adverse events is 50,000."

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FDA Asking for More Control Over Drug Compounding

F.D.A. Asking for More Control Over Drug Compounding - NYTimes.com:

"Among the changes proposed by Dr. Hamburg are requiring larger compounders to register with the F.D.A. and abide by its so-called good manufacturing practice [GMP], which requires drug producers to report any problems with their products to the agency. She is also recommending new labeling requirements that would make the origin and the risks of a compounded drug clear. She is also requesting that some products, including drugs with complex dosage forms, be banned for compounders.

“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen federal standards for nontraditional compounding,” Dr. Hamburg stated in the written testimony. “Such legislation should appropriately balance legitimate compounding that meets a genuine medical need with the reality that compounded drugs pose greater risks than those that are evaluated by F.D.A.”"

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Related articles

• Compounding pharmacies need FDA oversight (drughealth.blogspot.com)

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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• FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs (drughealth.blogspot.com)

Device Manufacturing 101: Orthopedic Implants and Instruments

Updated May 31, 2025

One of the links broke.

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Popular FDA cGMP online training classes, programs, and courses by SkillsPlus International Inc.

---  the original post follows below  ---

. . .  and don't forget about all the FDA's QSR regulations that have to be followed!

Device Manufacturing 101: Orthopedic Implants and Instruments:

". . . have you ever wondered about the steps that go into manufacturing these devices? There’s a lot of work in the process that turns an idea into an actual physical product, and often times it’s something we don’t think about.

During our recent trip to Northeast Indiana, we had the opportunity to visit a number of manufacturing sites and learn the high-tech processes and technology that go into producing orthopedic implants and instruments. Here’s how it works!"

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