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

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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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Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

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Read the full article:  Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

"PFAS are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 types of PFAS, some of which have been more widely used and studied than others. Many PFAS are impermeable to grease, water and oil. For this reason, beginning in the 1940s, PFAS have been used for many different applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints and fire-fighting foams, as well as in limited, authorized uses in cookware and food packaging and processing, referred to as food contact substances."

" ... the FDA has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to test samples of foods Americans typically consume for certain types of PFAS, and today we are making available recently analyzed data from these initial testing initiatives.

Overall, our findings did not detect PFAS in the vast majority of the foods tested. In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science."

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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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SkillsPlus International Inc. Announces Online GMP e-Learning Courses

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

SkillsPlus International Inc. proudly announces  the reintroduction and updating of our very popular GMP e-learning courses. 

FDA cGMP QSR GMP Training Courses by SkillsPlus Intl Inc.

Do you need . . . ?

• New employee GMP training awareness that is quick and easy?
• Annual refresher training that is on a flexible schedule for team members?
• Training solutions that are responsive to a demanding production environment?

Our LMS GMP Training solution is the answer to your needs!

• A current list of topics is available.
• 24-7 Availability
• An ever growing list of topics is planned.
• Our pricing is structured for today’s tight budgets

Additional Features

• Private classrooms allow your company trainer to share notes to all your employees.
• Trainers can be identified as classroom monitors to tracking student grades and completion.

Online Courses Currently Available - and view the details

• 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
• Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
• Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
• Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
• Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
• Plan to Production - Part F. Review the requirements for production process controls and validation.
• Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
• Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
• Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

Email us for a quote:  skillsplus@aol.com

The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

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Read the full article:  The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think - NPR.org

"Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results."

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