Showing posts with label regulation. Show all posts
Showing posts with label regulation. Show all posts

Saturday, December 28, 2019

Retail Sales of Tobacco Products - FDA.gov

Updated August 22, 2026

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Tobacco Products:
https://www.fda.gov/tobacco-products

---  the original post follows below  ---

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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Monday, February 11, 2019

FDA Signals Strengthening Regulation of Dietary Supplements - FDA.gov


Read the full press announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Snippets from the FDA Commissioner's statement:
". . . we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer."


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Friday, December 28, 2018

FDA releases statement underlining their powers to manage a selection of cannabis products

Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov


"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 
Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

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Wednesday, October 10, 2018

Tuesday, February 3, 2015

Obama: Let's Take Food Regulation out of FDA | RAPS

Read the full article: Obama: Let's Take Food Regulation out of FDA | RAPS:

"The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget.

"This new agency would be independent from FDA and have primary responsibility for food safety inspections, enforcement, applied research, and outbreak response and mitigation," the White House explains in the budget. "The new agency would be charged with pursuing a modern, science-based food safety regulatory regime drawing on best practices of both agencies, with strong enforcement and recall mechanisms, expertise in risk assessment, and enforcement and research efforts across all food types based on scientifically supportable assessments of threats to public health. The agency would also serve as the central point for coordinating with State and local entities and food safety stakeholders.""

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Wednesday, September 25, 2013

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity:

"In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:
  • to be used as an accessory to a regulated medical device; or
  • to transform a mobile platform into a regulated medical device."
You might also be interested in:
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)


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Monday, January 7, 2013

FDA - Proposed Rules To Implement FSMA

Food and Drug Administration logo
Food and Drug Administration logo (Photo credit: Wikipedia)
Updated December 19, 2020

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Frequently Asked Questions on FSMA - FDA.gov

- - -  original post follows below  - - -

The FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA). The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.:
  • 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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Thursday, November 29, 2012

GHTF Archives Can Be Found On The IMDRF Website

"The Global Harmonization Task Force (GHTF), the global medical device harmonization body no longer exists. The GHTF has been permanently replaced by the IMDRF (International Medical Device Regulators Forum), a successor organization comprised of officials from regulatory agencies around the world. The GHTF website no longer exists. Fortunately, the GHTF Archives are now housed on the IMDRF website. These archives (follow the hyperlink below) should be considered historic information, no longer current, and therefore, should not be acted upon.

http://www.imdrf.org/ghtf/ghtf-archives.asp "

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