December 2-3, 2020
The Preventive Controls for Human Food (PCHF) virtual blended course, presented by United Natural Products Alliance, is scheduled for December 2-3, 2020 and is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires that certain activities must be completed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls. This course developed by the FSPCA is the “standardized curriculum” recognized by the FDA and meets the requirements for a “preventive controls qualified individual” (PCQI).
“A Preventive controls qualified individual “means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.” This is the definition is from Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation § 117.3 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation § 507.3.” Food Safety Preventive Controls Alliance
“Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review, 4) reanalysis of the Food Safety Plan, and other activities as appropriate to the food. See § 117.180 and 507.53 for more details.” Food Safety Preventive Controls Alliance
The PCHF rule applies to dietary supplement and natural products if:
Upon successful completion of this FSPCA course you will receive your PCQI certificate. This UNPA course will provide tools and insight to help you to interpret and implement this new Food Safety Modernization Act (FSMA) rule within your dietary supplement business. Upon completion you will have the skills and knowledge to:
VIRTUAL BLENDED COURSE
The course is designed as a two-part course.
Part 1 is an online eLearning including 16 self-paced modules of FSPCA curriculum.
Part 2 will be taught by UNPA VP of Global Regulatory & Compliance, Larisa Pavlick. Larisa is an FSPCA Lead Instructor for Preventive Controls for Human Food (PCHF) and Foreign Supplier Verification Programs (FSVP), has 25+ years in the dietary supplement arena, and is the only former FDA investigator teaching this course. The December 2 -3, 2020 course will run from 8:00 am to 5:00 pm.
As a participant you will receive Ms. Pavlick’s vast knowledge of the natural products industry. At the end of the course you will be able to:
Register today by contacting Linda O’Dea, Regulatory and Event Coordinator, email@example.com.
FTC Sends Letters Warning 35 More Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Prevent or Treat COVID-19
Today the FTC issued a press release regarding an additional 35 new Warning Letters. These warning letters were issued to companies marketing and distributing products for the treatment of COVID-19. The letters were issued on May 27, 2020, after website compliance reviews were performed by the FTC staff.
This recent set of WLs was issued by the FTC and was not in conjunction with the FDA as seen in many of the previous warning letters related to COVID-19 enforcement.
Among the May 27th FTC Warning Letters:
All companies are cited for failure to substantiate one or more claims, which is a violation of the FTC Act. Each company has been warned to make corrections and cease making false claims within 48 hours or face a potential injunction.
The FTC has a full listing of Warning Letters on their website.
The UNPA staff is collaborating and working with the American Association of Naturopathic Physicians (AANP) to help develop a response strategy. We will discuss this topic in more detail on June 18, 2020, during a UNPA member-only call.
SALT LAKE CITY (June 3, 2020) — UNPA has partnered with Alibaba.com to help connect buyers and sellers - all online, at the Alibaba.com US Supplements & Nutrition Online Trade Show happening July 7-10, 2020.
This is a carefully curated and exclusive event designed to help US businesses showcase their products in front of the right business buyers and drive demand during this difficult time.
Companies wishing to exhibit at this event must become an Alibaba.com member and be based in the US. Buyers may attend the event for free, after completing an application and being verified by Alibaba.com. UNPA Members have access to a reduced pricing package to become Alibaba.com members. If interested in leveraging this opportunity, please contact Clint, at firstname.lastname@example.org for more information.
Register at alibaba.com before June 12th to secure a spot.
What to expect:
Inquiries contact Clint Calder, Director of Marketing, email@example.com.
Larisa Pavlick, VP of Global Regulatory & Compliance at The United Natural Products Alliance (UNPA), has been elected to the US Hemp Authority Board, as the US Hemp Authority seeks to expand their stakeholder reach in the broader hemp farming, hemp product and retail communities.
“The U.S. Hemp Authority decided to increase the number of board members to represent a broader section of hemp stakeholders, as well as to secure further industry support for the Authority’s position and initiatives. The dietary supplement trade associations have become more active in the hemp industry and we're excited to help with this venture. Larisa Pavlick was invited to join the U.S. Hemp Authority Board based on her expert regulatory background and current position with UNPA. We are looking forward to continuing our work with the dietary supplement trade associations and are elated to welcome Larisa to the U.S. Hemp Authority Board of Directors,” said Dr. Marielle Weintraub, President of the U.S. Hemp Authority.
The US Hemp Authority (USHA) is a vital resource in the Hemp and Hemp extract (including CBD) community. The USHA certification program was designed to help retailers and customers to build trust and confidence in these increasingly popular products. Larisa Pavlick shared:
I am pleased to join the Hemp Authority Board as a Director, representing the dietary supplement industry. I have been working with representatives from the US Hemp Authority for several years and was honored to be asked to participate on the Board and the Technical Committee. It was a tough decision to determine which area I wanted to focus and where I felt I could make the most impact.
I have provided comments for the USHA Guidance Procedure for both the 1.0 and 2.0 versions based on my nearly 25 years of background and experience in the dietary supplement industry and as a former FDA investigator. The team at UNPA and I look forward to the work ahead, as we strive to provide a pathway for hemp extracts to become a premiere category in the dietary supplement and natural products industry.
Patricia Knight, former chief of staff to retired Sen. Orrin Hatch, reflects on the forces that led to DSHEA.
By Patricia Knight, senior political advisor, United Natural Products Alliance | Sep 03, 2019
You might say I was an accidental Senate staffer. It was the early 1990s. My job tenure had dwindled to nine months’ duration. Not good.
Working on the House Appropriations Committee was a dream job. But it was cut short when my boss, Silvio O. Conte, a ranking Republican (from Massachusetts) on the House Appropriations Committee, suddenly died.
Returning to the U.S. Department of Health and Human Services (HHS) as a Deputy Assistant Secretary didn’t work so well, either. President George H. W. Bush lost his re-election, and I lost my job.
As luck would have it, on January 21, 1993—the day after President Bill Clinton’s inauguration—I started a new volunteer job at Republican Sen. Orrin Hatch’s office. I didn’t have a desk. I didn’t have a paycheck. What I did have was a fantastic opportunity to be a part of history-in-the-making, learning the legislative process from a world-class master who never stopped his relentless effort to get the job done. And with the Dietary Supplement Health and Education Act of 1994 (DSHEA), Hatch got the job done.
With a new name, the UNPA Asia Report, UNPA has published its second quarterly special section, this one in the 4Q17 issue of Asiaceutical Insights, a trade publication published in China by Herbridge Media, with distribution throughout China, Japan and southeast Asia. This special business-to-business section is an ongoing feature in the magazine.
The UNPA Asia Report strives to highlight market information, trends and developments within the U.S. dietary supplement industry for Chinese, Asian and U.S.-based companies and will feature a number of UNPA member companies and MOU partners, with a focus on UNPA’s ongoing efforts to improve regulatory compliance and product quality and transparency within the U.S. marketplace.
If you are interested in participating in editorial content and/or advertising, please contact Frank Lampe, 720.398.8172.
View and download a PDF (4.8 MB) of the 4Q17 issue of the UNPA Asia Report
View and download a PDF (65 MB) of the entire 4Q17 issue of Asiaceutical Insights
Asiaceutical Insights (Herbridge Media) website: http://www.herbridge.com/html/en/
UNPA created a 16-page special section that has been included in the Fall 2017 issue of Asiaceutical Insights, a trade publication published in China by Herbridge Media, with distribution throughout southeast Asia. The special section serves as a primer about the U.S. dietary supplement market for Chinese and Asian companies and features a number of UNPA member companies and MOU partners, with a focus on UNPA’s ongoing efforts to improve product quality and transparency within the U.S. marketplace.
View and download a PDF (2.3 MB) of this special section: “The U.S. Dietary Supplement Market: An Overview Of Issues And Trends”.
View and download a PDF (115 MB) of the entire Fall 2017 issue of Asiaceutical Insights.
Asiaceutical Insights (Herbridge Media) website: http://www.herbridge.com/html/en/
Compiled by UNPA staff
FAQ: Preventive Controls Qualified Individual (PCQI)