The UNPA January/February virtual training courses have been scheduled. We’re excited to announce a two day GMP Inspection Training course and the addition of a February Preventive Controls for Human Food blended course.  
 
Both courses will be taught by Larisa Pavlick, UNPA’s Vice President Global Regulatory and Compliance. With over 25 years in the dietary supplement and natural products industry, Larisa is the ONLY instructor who has worked for the Food and Drug Administration. Her primary responsibility was to conduct inspections and investigations for dietary supplement firms and ingredient suppliers. She also has extensive industry knowledge in product development, quality, regulatory affairs, daily operations and technical purchasing. Her experience in the full product life cycle from development purchasing through manufacturing. She is a FSMA Preventive Controls for Human Foods Lead Instructor and is FDA trained and qualified to conduct GMP training. Her unique perspective will provide invaluable insight into the world of FDA audits.

COURSE DESCRIPTION
The GMP 111 two-day virtual training is a comprehensive course designed for owners, operators, operations staff to help you understand your responsibilities under the law. This course may help you to meet the requirements of 21 CFR Part 111.12 for qualified employees within a dietary supplement firm.  During these intense two days, Larisa will explain what the FDA is looking at during the course of an inspection with the objective of helping you to be more prepared.  She will share with you the top ten FDA citations and provide information to help you implement solutions for each.  

The course will summarize the state of the industry including trends and recent regulation regulatory action, discuss new and evolving regulations, and current events. You will get a full understanding of dietary supplement regulation, laws, and regulatory guides including the Food, Drug and Cosmetic Act, 21 CFR Part 111- cGMP for Dietary Supplements, and public FDA reference and resources used extensively by the FDA investigators.  

Over the course of these two days, we will go through a full dietary supplement GMP investigation from Larisa's perspective as a former FDA investigator and will share with you her experience and how she would evaluate compliance from the general walk through, to observing manufacturing operations, document review, and most importantly- product review.  This course will also demystify the requirement for “written procedures” and help you to write and implement specifications which are scientifically valid and help you to understand the regulatory requirements.
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Finally, Larisa will discuss the regulatory classifications of investigations, the close-out meeting, and discuss post-inspectional activities including a voluntary written response to a form FDA-483 (Inspectional Observations).

You’ll learn:

• We will focus on how to be prepared when the FDA returns, how to audit your suppliers virtually, what have we learned about supply chain and managing adulteration during this new era, and COVID-19 refreshers for sanitation and personnel practices.
• Your responsibilities under the law
• The top 483 - Inspectional Observations and how to avoid them
•  How to prep for an FDA Establishment Inspection 
• A step-by-step review of the inspection process and the new Compliance Program for dietary supplements
• A review of the Food Safety Modernization Act, including PCQI and FSVP

​Register today by contacting Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com. ​
Registration: Regular Price $1,799. UNPA Member: $1,499

COURSE DESCRIPTION
The Preventive Controls for Human Food (PCQI) virtual blended course, presented by United Natural Products Alliance, is scheduled for February 23-25, 2021. This three day/four hours per day course 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:

• The product is marketed or sold with a Nutrition Facts panel in the U.S.
• You sell or purchase raw materials
• You are a manufacturer responsible for qualifying suppliers of raw materials
• You are a brand owner and you distribute in the U.S. You are ultimately responsible for the products under your labels even if you utilize contract manufacturers.
• If you are importing products from a foreign supplier. You must ensure they meet all applicable food safety standards. Raw materials and food suppliers must be qualified using the PCFH rule.
• All operations are required to have training specific to 21 CFR Part 117.4-Employee training
• All operations are required to apply applicable sections from Subpart B-Good Manufacturing Practices which are above and beyond the requirements of 21 CFR Part 111 DS-GMPs including allergen cross contamination prevention.
• All companies maintain records covered under PCHF including training, written procedures for 117.420, and Foreign Supplier Verification Programs (FSVP).
• It is highly recommended by UNPA that all companies are trained in Subpart G-Supply Chain Programs. Although dietary supplements are exempt from this section, this IS the FDAs modernized approach to supplier qualification. Everyone can benefit from this section. 

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: 

• Conduct the required written hazard analysis 
• Establish and implement a food safety plan
• Prepare your operation for the FSMA PCQI regulations

VIRTUAL BLENDED COURSE
The course is designed as a two-part course.

Part 1
Part 1 is an online eLearning including 16 self-paced modules of FSPCA curriculum. 

• Will take approximately 6-12 hours to complete based on background and experience.. However, you have up to six months to complete all 16 modules.  
• If you do not participate in Part 2 after six months, you will be required to repeat Part 1. No refunds will be given.
• Our current 2020/2021 training schedule includes conducting Part 2 PCHF courses again in May 18-20,  September 22-24 and in December 2021.
• Includes skills assessments and exercises related to hazard analysis and food safety plans.
• Upon completion of Part 1 you will receive a certificate by email allowing you to participate in Part 2.
• Part 1 must be completed prior to attending Part 2.

Part 2
The February 23-25, 2021 course will run from 8:00 am to 12:30 pm MST. 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:

• Conduct hazard analysis and determine appropriate preventive controls
• Define process, allergen, sanitation and supply-chain preventive controls
• Discuss verification, validation, recall and recordkeeping requirements 

Receive UNPA tools to apply this rule to your dietary supplement operation including an example Food Safety Plan for one of five key ingredient categories including various botanical models including green tea, Echinacea, or hemp, probiotic, fish oil.

​Register today by contacting Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com. 
​Registration: Regular Price $1,799. UNPA Member: $1,499

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:

• Thirteen of these Warning Letters were issued to clinics and physicians related to treatments including intravenous (IV), ozone therapies, and immunity boosting injections.
• One to an organization offering stem cell treatment.
• One for electromagnetic field blocking patches.
• Two to clinics and a health center for homeopathic treatments.
• Seventeen of the FTC warning letters are issued for “Vitamins, Supplements, Silver, and Chinese Herbal Treatments.”
• Within this list of seventeen, it appears that at least five of these warning letters were issued to clinics, wellness groups, healing or medical centers. 
• One within this category was issued to an individual doctor. 

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. 

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.
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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.
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Asiaceutical Insights (Herbridge Media) website: http://www.herbridge.com/html/en/

​By Loren Israelsen, President, United Natural Products Alliance