Educational Webinars

April 2023 | Access on Demand (AHPA Members: $199; Non-Members: $399)

Manufacturers of dietary supplements play a key role in consumer safety. If an adverse event associated with a dietary supplement occurs, the manufacturer is responsible for documenting and thoroughly investigating the issue. As for serious adverse events reports (SAERs), manufacturers are obligated to document and submit any such reports that meet the law’s definition of “serious” to the U.S. Food & Drug Administration (FDA) in a timely matter. Failure to submit SAERs to FDA has consequences.
 
View this webinar to learn more about post-market surveillance and adverse event reporting, including:

• An overview of the industries’ obligations per the regulation

• What defines an adverse event and a serious adverse event

• Requirements for submitting serious adverse event reports

• Issues that can occur when reporting and how to avoid them

• A focus on what FDA does once a report is received

• How to scale your business and stay align with regulatory requirements

• Serious adverse event reporting data and observations

Presenters:

• Kristy Appelhans, Vice President, Global Consumer Safety, Herbalife Nutrition

• Rick Kingston, President, SafetyCall International

• Oliver Ou, CFSAN Adverse Event Reporting System (CAERS) Coordinator, U.S. Food & Drug Administration

• Michael McGuffin, President, AHPA

Handouts (included with registration):

• Webinar slides

• Speaker bios

February 2023 | Access on Demand (AHPA Members: $199; Non-Members: $399)

The industry has seen an increase in FDA scrutiny, causing confusion about the FDA’s guidance on the strengths and composition of finished dietary supplement products and ingredients. Though there has been no change in regulation, FDA has expressed “concern” that botanical ingredients are not uniformly distributed throughout product batches and wants to see that testing, dictated on the product specification, is conducted to ensure this uniformity. This is a long-standing issue for all companies, big and small. Get a diverse perspective from industry experts and learn how to navigate this conversation with FDA.

View this webinar to learn more about the FDA’s guidance on the strengths and composition of finished dietary supplement products and ingredients, including:

• What compliance means under 21 CFR 111.70 and 21 CFR 111.75

• Acceptable documentation to show FDA that specifications on strength & composition are met

• What to do if you disagree with an investigator

• AHPA’s resources to help protect your business from this issue

Presenters:

• Staci Eisner, Vice President of Quality & Regulatory Affairs, Cortex Scientific Botanicals

• Tara Couch, Owner, TLC Regulatory and Laboratory Consulting

• Will Woodlee, Partner, Kleinfield Kaplan & Becker LLP

Handouts (included with registration):

• Webinar slides

• AHPA Primer on Importing and Exporting of CITES-listed Species (August 2022)

January 2023 | Access on Demand (AHPA Members: $199; Non-Members: $399)

In November 2022, the CITES Conference of the Parties (CoP19) met in Panama City, where proposals to add new botanical species (including all species of Rhodiola spp.) to CITES Appendix II were accepted. Under CITES Appendices, 30,000 flora species are protected to ensure the international trade of plant species is not threatened.

View this webinar to learn more about CITES, including:

• History of CITES and relevance to the natural products industry

• What is entailed when a botanical gets listed with CITES

• Process for compliance if you are importing CITES-listed botanicals

• AHPA resources on CITES

Presenters:

• Heather Harcum, Permits Biologist, U.S. Fish & Wildlife Service

• Wilson Lau, Vice President, Nuherbs

• Jane Wilson, Director of Program Development

Handouts (included with registration):

• Webinar slides

• AHPA Primer on Importing and Exporting of CITES-listed Species (Rev. 2023)

October 2022 | Access on Demand (AHPA Members: FREE; Non-Members: $99)

Doug Gansler, Esq., Chair of the State Attorneys General Practice at Cadwalader, Wickersham & Taft and former two-term Maryland Attorney General and President of the National Association of Attorneys General, will present an exclusive State Attorneys General update to AHPA members on relevant enforcement and policy priorities related to dietary supplements. State Attorneys General are the primary state regulators of our industry, enforcing individual state consumer protection acts and marketing regulations.
 

Presenter:

• Doug Gansler, Esq., Chair of the State Attorneys General Practice at Cadwalader, Wickersham & Taft 

June 2022 | Access on Demand (AHPA Members: FREE; Non-Members: $99)

Justice – Equity – Diversity – Inclusion (J.E.D.I): four powerful words that are trending largely due to the current political landscape and social climate, but what do these words mean? In theory, J.E.D.I means everyone has equitable access and opportunity. Within the workplace, differences in age, color, ethnicity, religion, sexual orientation, race, and other characteristics such as personality and personal interests shouldn’t become a barrier to a positive work environment.

Attend this webinar to gain an understanding of how the J.E.D.I Collaborative embeds justice, equity, diversity and inclusion into our food ecosystem via the natural products industry. Then listen as AHPA members provide firsthand accounts of their own diversity, equity and inclusion (DE&I) journeys. Discussions will include the process, commitment, and experience of implementing DE&I initiatives; how companies evolved and are getting to a place of allyship; and examples of resources and tools available.

In the webinar, our expert presenters:

• Discuss their DE&I journeys

• Share effective strategies for integrating DE&I initiatives at your workplace

Presenters:

• Cynthia Billops, VP Operations, Membership & Belonging, One Step Closer & J.E.D.I Collaborative

• Amber Littlejohn, Esq., Executive Director, Minority Cannabis Business Association

• Erin Douglas, Social & Environmental Responsibility Manager, Banyan Botanicals

• Laura Najera, RAC, Manager Regulatory Affairs (International), Metagenics

June 2022 | Access on Demand (AHPA Members: $199; Non-Members: $399)

This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that are the primary focus during U.S. Food and Drug Administration (FDA) facility inspections.

FDA inspects facilities to ensure their compliance with regulations and laws surrounding the manufacturing, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the U.S. Attend this webinar to gain insight on how FDA approaches GMP facility inspections, with the goal of understanding how to always be inspection ready as an organization, and how best to prepare for inspection by FDA. This knowledge will assist businesses in better allocating and directing their compliance resources.

Prior to the COVID-19 pandemic, an inspector could drop by your facility at any time without advance warning. In light of the pandemic, FDA will now pre-announce domestic onsite inspections of regulated businesses, excluding tobacco inspections. Having a plan in place that includes inspection best practices will go a long way in eliminating the stress that undoubtedly comes when you’re put on notice that an inspection is imminent.

In this webinar, our expert presenters:

• Provide an overview of the current cGMP enforcement landscape – who, what, where and why FDA can inspect

• Provide examples of how to prepare for an FDA inspection

• Review the dos and don’ts of working with an FDA inspector in your facility

• Share first account FDA inspection experiences

Presenters:

• Will Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP / AHPA General Counsel

• Steven Yeager, Director of Quality and Regulatory Affairs, Mountain Rose Herbs

May 2022 | Access on Demand (AHPA Members: $199; Non-Members: $399)

You’ve worked hard to build your business or body of work and you want to protect it…but you don’t know if you should copyright or trademark your work. You’ve conducted online research and – instead of gaining knowledge – you’re more confused than before you began. Trademarks, patents, and copyrights are different types of intellectual property (IP).

The United States Patent and Trademark Office (USPTO) grants patents and registers trademarks. Trademarks are an essential part of your business. If a name or logo is being used to advertise your business, you very well might have a trademark. If that’s the case, you should protect that name or logo through the federal registration process. According to the United States Patent and Trademark Office (USPTO), a trademark is defined as any word, phrase, symbol, design, or a combination of these things that identifies your goods or services. It’s how customers recognize you in the marketplace and distinguish you from your competitors. The word “trademark” can refer to both trademarks and service marks. A trademark is used for goods, while a service mark is used for services.

The U.S. Copyright Office at the Library of Congress registers copyrights. According to the U.S. Copyright Office, a copyright is a type of IP that protects original works of authorship as soon as an author fixes the work in a tangible form of expression. Original works can include books and research. It’s what businesses generally think of first when an item of IP has been created that they want protected from use by others.

In this webinar, our expert presenters:

• Provide suggestions for acquiring, protecting, and enforcing your IP rights

• Share effective ways to differentiate between copyrights and trademarks

Presenters:

• Nancy Del Pizzo, Partner, Rivkin Radler, LLP

• William Rava, Partner, Perkins Coie, LLP

• Erica Stump, President/Owner, Erica W. Stump, P.A. Law Firm

January 2022 | Access on Demand (AHPA Members: $199; Non-Members: $399)

California’s Proposition 65 ("Prop 65"), officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to inform Californians about exposures to chemicals known to cause cancer, birth defects or other reproductive harm, and requires the State of California to maintain and update a list of these chemicals on a yearly basis. The Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of Prop 65, and is authorized to assess health risks posed by environmental contaminants.

Pursuant to Prop 65, companies conducting business in California must provide a clear and reasonable warning to consumers about exposures to any of the approximately 900 chemicals on OEHHA’s list, unless the exposures do not exceed established threshold levels. The warning message must be available to the consumer prior to exposure.

AHPA recently published an update to its Guidance on California Proposition 65 and Hemp Products to recognize the impact of the passage of California AB 45 Industrial hemp products, which was signed into law by Governor Gavin Newsom on October 6, 2021. The AHPA document provides guidance to the hemp industry about the regulatory and liability implications of Prop 65 for hemp and hemp-derived products, including cannabidiol (CBD), sold in the State of California. Following the passage of AB 45, certain hemp-derived products are now recognized as lawful foods, dietary supplements, and cosmetics, and may now be able to utilize Prop 65’s provision for naturally occurring constituents that are Prop 65 listed chemicals, such as delta-9 tetrahydrocannabinol and β-myrcene. This provision recognizes that if a listed chemical is naturally occurring in a food, human consumption of that food does not constitute an “exposure” for the purposes of Prop 65.

In this webinar, our expert presenters:

• Provide an overview of the clear and reasonable warning regulation, including recent changes and amendments that impact the cannabis industry

• Identify the specific warning requirements placed on marketers of products sold in the State of California, and the legal ramifications for failure to comply

Presenters:

• Carol Monahan Cummings, Chief Counsel, Office of Environmental Health Hazard Assessment (OEHHA)

• Chris Koepsel, General Counsel, Papa & Barkley

• Will Wagner, Senior Associate, Arnold & Porter Kaye Scholer LLP

• Jane Wilson, Director of Program Development and Cannabis Committee Staff Liaison, American Herbal Products Association (AHPA)

October 2021 | Access on Demand (AHPA Members: FREE; Non-Members: $99)

Doug Gansler, the Chair of the state Attorney General practice at Cadwalader, Wickersham & Taft and the former two-term Maryland Attorney General and President of the National Association of Attorneys General, will present an exclusive update to AHPA members on relevant enforcement and policy priority updates of the state Attorneys General in regard to supplements. State Attorneys General are the primary state regulators of our industry, enforcing individual state consumer protection acts and marketing regulations. In particular, General Gansler will touch on pertinent topics such as COVID-19 claims, weight loss, muscle enhancement, CBD and hemp products, and other state regulatory legal issues.

Presenter:

• Douglas Gansler, Partner, Cadwalader, Wickersham & Taft LLP

September 2021 | Access on Demand (AHPA Members: $99; Non-Members: $199)

The Federal Trade Commission (FTC) enforces against false, misleading, and deceptive advertising in any medium. For example, under these authorities, the agency requires that advertisers have adequate substantiation for their claims and provide appropriate disclosures. 

As technology has have changed how and where firms advertise products, the FTC has developed principles for applying its authorities to new media and marketing practices. 

Learn how testimonials and social media can trip you up if you are not paying attention to these principles, which govern not only FTC enforcement but also the approaches taken by state law enforcement agencies (e.g., attorneys general offices), plaintiffs’ lawyers who seek to put your money in their pockets, self-regulatory bodies, and competitors challenging your marketing. Ignorance is no excuse, so why learn the hard way? 

To assist in complying with the law while maximizing effective marketing in the digital world, watch this webinar to learn the requirements and how to avoid the potholes of noncompliance. The panel includes an industry attorney and a scientist, who will address legal standards, today’s regulatory environment, and the lawsuit risks and liabilities marketers face if claims are not adequately substantiated. The panel also includes an FTC representative, who provides the agency’s perspective, updates on recent enforcement actions, and a discussion of the level of substantiation respondents in those actions possessed or did not possess.

Presenters:

• Rich Cleland, Assistant Director, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission

• Douglas Kalman, Ph.D., R.D., Vice President of Scientific Affairs, Nutrasource

• Will Woodlee, Partner, Kleinfeld, Kaplan and Becker, LLP / AHPA General Counsel

September 2021 | Access on Demand (AHPA Members: $99; Non-Members: $199)

AHPA has published a Hemp Lexicon intended to support the standardization of the terminology used in the cultivation, processing, manufacturing, and labeling of hemp and products derived from hemp as defined in U.S. federal law. The lexicon is a reference tool for the hemp industry as well as federal, state, tribal, and other jurisdictions that oversee the hemp industry to provide guidance and encourage clear, consistent communication. The definitions in the lexicon also provide consumers with a common understanding of the diverse terms used in the description, marketing, and labeling of hemp products as well.

The Hemp Lexicon was developed by a working group of the AHPA Cannabis Committee and included hemp growers, manufacturers, processors, and product marketers who use this terminology in their operations and communications. Many of the terms in this lexicon have been long established in other AHPA documents, and were developed and implemented by AHPA in consultation with a group of global botanical experts, and are harmonized with or have been adopted by other national governments and regulatory bodies. Where current hemp industry usage of specific terms for marketing purposes differs from the long-established botanical industry definitions, the lexicon acknowledges those differences and recommends alternate terminology that may be integrated by the hemp industry as it matures. These alternate terms are provided with the long-term goals of achieving consistency within the industry and of establishing a common consumer understanding of hemp product labeling. AHPA strongly encourages the hemp industry to utilize terminology consistent with established botanical industry usage whenever possible.

In this webinar, our expert presenters:

• Provide historical background on the long-established use of botanicals as it relates to the Hemp Lexicon

• Speak to the importance of establishing standardized terminology as new hemp regulations emerge

• Provide FDA’s perspective on standardized terminology

Presenters:

• Michael McGuffin, President, AHPA

• Patricia Kim, Legal Counsel, Papa & Barkley 

• Debby Miran, Consultant, Miran Consulting, Inc.; Former Commissioner on Maryland Medical Cannabis Commission

July 2021 | Access on Demand (AHPA Members: $199; Non-Members: $399)

With Amazon leading the charge as the industry leader in e-commerce, your brand’s customers are likely on Amazon. So, if you’re bypassing the Amazon marketplace as a means of distribution, you’re not meeting your customers where they shop. For many dietary supplement companies, especially small businesses, navigating the Amazon marketplace hasn’t been an easy venture. From uncontrolled third-party sellers re-selling your products on Amazon with no obligation to follow the standards your brand is known for, to having to continuously compete with counterfeiters who sell unverified dietary supplements to shoppers, growing the value of your brand via the Amazon marketplace is a lofty and often unattainable goal for many companies.

Selling dietary supplements has become increasingly more difficult on the Amazon marketplace. Please join us for a webinar on July 7 for guidance on how to navigate your brands through, and maximize your potential on, the Amazon marketplace. Robert Principe of Netrush, an Amazon agency that provides services to companies that sell products via the Amazon marketplace, will discuss the latest insights on Amazon’s policies and best practices (and practices to avoid) for successfully leveraging the marketplace platform. Shawn Fenton, a global ecommerce strategist with Natural Factors Nutritional Products, will provide perspective on how his company has successfully navigated Amazon, including by implementing an OmniChannel approach, while protecting the company’s brand and adapting to evolving Amazon policies. AHPA General Counsel Will Woodlee will discuss recent changes to Amazon’s dietary supplement policies, and their intersection with federal regulatory requirements.

If you’re struggling with your online presence, you don’t want to miss this webinar.

Presenters:

• Shawn Fenton, Global Ecommerce Strategist, Natural Factors

• Robert Principe, Director of Business Development, Netrush

• Will Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP / AHPA General Counsel

July 2021 | Access on Demand (AHPA Members: FREE; Non-Members: $99)

webPOISONCONTROL® is a free online tool and app that provides immediate triage recommendations and automated follow up for acute, unintentional exposures to a vast array of products and substances. It was created for those who cannot or will not call Poison Control but still need its help for suspected poisonings, bringing the expertise of Poison Control to consumers where they want it – online.

webPOISONCONTROL® has managed more than 548,000 exposures to common substances like personal care products, cleaning products, medicines and homeopathic remedies, pesticides and insecticides, plants, bites and stings, recreational substances, and more. Join us if you are curious about the data that drives the recommendations provided to consumers by the tool, and how you can work with us to conduct product safety surveillance.

In this webinar, our expert presenters:

• Briefly describe the U.S. Poison Control System

• Demonstrate the consumer-facing side of webPOISONCONTROL®

• Explain how the tool determines the potential toxicity of consumer products and advises users, and how companies can help us make sure our information on their products is correct

• Show trends and descriptive statistics in the webPOISONCONTROL® data set using a real-time exposure surveillance dashboard

Presenters:

• Kelly Johnson-Arbor, M.D., FACEP, FUHM, FACMT, Medical Director of Hyperbaric Medicine, MedStar Georgetown University Hospital; Co-Medical Director, National Capital Poison Center

• Krista Osterthaler, MPH, Director of Strategic Partnerships, National Capital Poison Center

June 2021 | Access on Demand (AHPA Members: FREE; Non-Members: $99)

The Lacey Act of 1900 (the Lacey Act) was originally passed to prohibit the interstate sale and transportation of game killed in violation of local laws. It was modified by the Food, Conservation and Energy Act of 2008 to also address illegal international logging practices and trade. As a part of these modifications, the Lacey Act requires importers of all plant products to submit an import declaration at the time of importation.

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has been charged with the oversight of the Lacey Act’s import declaration requirement, which it has implemented for different imported plant product commodities according to a phased schedule. Certain common food crops and cultivars are excepted from the Lacey Act’s import declaration requirement; APHIS maintains a non-exhaustive list of these commodities.

Import declarations under the Lacey Act are collected by the Agency in an electronic format and include a variety of information, including, of particular note to the herbal product industry, the country of harvest for all imported products. The latest phase of Lacey Act import declaration requirement implementation will go into effect on July 1, 2021, and will for the first time require import declarations for certain essential oil commodities.

Attend this webinar for a discussion about the import declaration requirements and how to comply to those requirements.

Presenters:

• Dorothy Wayson, National Policy Manager, Lacey Act Program, USDA, APHIS, PPQ

• John Schoenig, Partner, Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP

• Elizabeth Baldwin, Environmental Compliance Officer, Metropolitan Hardwood Floors, Inc.

• Joe O’Donnell, Director, Government & Public Affairs, International Wood Products Association

March 2021 | Access on Demand (AHPA Members: $99; Non-Members: $199)

According to the U.S. Food and Drug Administration (FDA), its Compliance Programs exist to provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. On September 30, 2020, FDA released its Compliance Program Guidance Manual (CPGM) titled “Dietary Supplements – Foreign and Domestic Inspections, Sampling, and Imports.” Per FDA, the goal of this CPGM is to ensure companies consistently manufacture dietary supplements of acceptable quality and minimize consumers’ exposure to adulterated and/or misbranded dietary supplements.

The CPGM sheds light on FDA’s inspectional approaches based on FDA resources, priorities, and dietary supplement establishment operations. It identifies factors that will lead to a company’s being classified as a “firm known to manufacture high-risk dietary supplements.” It asserts that firms with high-risk dietary supplements include, but are not limited to, firms manufacturing botanical supplements.

The CPGM also specifies what type of inspection should be conducted based on the reason for the inspection itself (e.g., full scope manufacturing inspection, limited focus manufacturing inspection). It also includes what items or areas FDA should emphasize while onsite at your facility.

In this webinar, our expert presenters share their perspectives on the CPGM. Aaron Secrist will speak from the vantage point of industry, and Justin Boyd will provide insight from FDA’s point of view.

Presenters:

• Justin Boyd, Investigator, Office of Regulatory Affairs (ORA), U.S. Food & Drug Administration (FDA)

• Aaron Secrist, Executive Vice President of Quality, Regulatory Affairs & Operations, NOW Health Group, Inc.

March 2021 | Access on Demand (AHPA Members: $99; Non-Members: $199)

AHPA has, since 1997, conducted quantitative surveys to estimate annual harvests of certain native North American herbs in commerce. A new paper reporting survey data on both cultivated and wild harvests of over 41 commodities for the years 2011-2013, and 45 commodities for 2014-2017, is the focus of an upcoming webinar featuring AHPA staff scientists and the chair of its Botanical Raw Materials Committee.

Plant species were selected for inclusion in the surveys based on their use in herbal products and their status as wild harvested commodities, for at least some part of their market. The survey has expanded over the years to include additional species and commodities, and the format continues to evolve with the incorporation of new elements. For example, for the years 2014-2017, data was solicited on certified organic quantities of each for the 45 surveyed raw material commodities.

Data reported represents aggregate harvest quantities for specific commodities provided to AHPA by primary raw material producers who are collectors, aggregators, distributors, or suppliers of botanical raw materials.

Product manufacturers, ingredient companies, and primary suppliers of raw materials have a vested interest in continuing the harvest of plants in a sustainable manner that assures their use by generations to come. According to the Fish and Wildlife Service of the U.S. Department of the Interior, AHPA’s Tonnage Survey is “a vital index of native U.S. botanical consumption."

Presenters:

• Holly Chittum, Project Scientist, AHPA

• Edward Fletcher, President, Native Botanicals, Inc.; Chair, AHPA Botanical Raw Materials Committee

• Holly Johnson, Ph.D., Chief Science Officer, AHPA

June 2020 | Access on Demand (AHPA Members: $99; Non-Members: $199)

Organizations are faced with continually identifying risks and finding solutions for key social, brand, and environmental challenges. Companies need credible and practical tools to collect metrics and facilitate analysis of policies and practices when developing sustainability goals and evaluating strategy. A critical means by which to accomplish this task is a sustainability self-assessment. A sustainability audit or self-assessment is a tool that’s used to compare your company’s practices with best practices for sustainability, and can be designed in a way that is simple and easy to use or complex and detailed.

Presenters in this webinar address different approaches to sustainability self-assessment, discuss various sustainability standards, and how to create realistic science-based targets, and present examples that will help companies of all sizes plan and execute meaningful self-assessments.

In this webinar, our expert presenters:

• Highlight and define reputable solutions that will help you build leading sustainability strategies and goals for your company

• Discuss Intertek’s Total Sustainability Assurance program, how it will work, and what the future holds for its company

• Define the benefits of B Corp Certification

• Provide a first-hand account of conducting a sustainability self-audit

Presenters:

• Erin Douglas, Corporate Responsibility and Community Relations Manager, Banyan Botanicals

• Tim Greiner, Managing Director, Pure Strategies, Inc.

• Simona Romanoschi, Sr. Director, Sustainability Programs, Business Assurance Innovation, Intertek

• Lindsey Wilson, Senior Associate, U.S./Canada Business Development Team, B Lab

June 2020 | Access on Demand (AHPA Members: $99; Non-Members: $199)

Consumer demand for immune support products has dramatically increased in recent months. At the same time, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) are actively monitoring the market for products with fraudulent prevention and treatment claims. FDA and FTC are exercising their authority to protect consumers from firms selling unapproved products and making false or misleading claims, including by issuing dozens of warning letters in recent months.
These principles are followed closely by plaintiffs' lawyers and state law enforcers who are also actively looking for companies with unsubstantiated marketing claims. This webinar will help you understand effective methods for substantiating your immune support claims so you can minimize enforcement and litigation risks.
In this webinar, our expert presenters:

• Explain ways to ensure your marketing claims for herbal immune support products are substantiated, truthful and not misleading

• Industry experts review several methods they have used to ensure their dietary supplement product claims are well substantiated – including randomized, controlled clinical trials on a well-known elderberry product; in vitro testing to support the legitimacy of the product; and the relevance of use and training in substantiating the effectiveness of traditional Chinese herbal formulations

Presenters:

• Mary Bove, ND, Scientific Advisory Board, Gaia Herbs

• John K. Chen, Ph.D., O.M.D, L.Ac., Medical Consultant, Evergreen Herbs & Medical Supplies

• Stephen Turner, Vice President of Sales, US, PharmaCare US, Inc.

May 2020 | Access on Demand (AHPA Members: $99; Non-Members: $199)

Enactment of the 2018 Farm Bill fully removed hemp products containing not more than 0.3% THC from the scope of the Controlled Substances Act. As the hemp products market continues to expand in its wake, new entrants and legacy marketers alike are attempting to gain a leg up on the competition by differentiating their brands through creative marketing measures, which sometimes leads down a slippery slope of claims presenting legal and regulatory risk.

The Federal Trade Commission (FTC) enforces against false, misleading, and deceptive advertising in any medium. Under these authorities, the Agency requires that advertisers have adequate substantiation for their claims and provide appropriate disclosures. Among other factors, the claims made for a hemp-derived product can also impact the product’s classification under and compliance with the Federal Food, Drug, and Cosmetic Act. Successfully navigating both the FTC’s and the U.S. Food and Drug Administration’s (FDA’s) requirements can mean the difference between a profitable hemp-products business and an early, forced exit from this emerging market. Both agencies have consistently and sometimes jointly acted against marketers of hemp-derived CBD products based on claims issues. More recently, the private plaintiffs’ bar has emerged as a new and formidable threat to this nascent industry. 

Attend this webinar to gain guidance and practical tips on how to successfully market your hemp-derived products consistent with the requirements of the FDA and FTC. An FTC representative will provide FTC’s perspective, summarize recent enforcement actions, and discuss the level of substantiation respondents in those actions possessed or did not possess. Industry attorneys will address legal standards, today’s ever-evolving regulatory environment, and the lawsuit risks and liabilities marketers of hemp products face.

In this webinar, our expert presenters:

• Explain the level of required substantiation as dictated by the detail of the claim that you make for your product

• Discuss having claim substantiation processes in place to ensure your claims are substantiated and reviewed BEFORE they are published

• Explain how FDA regulates your hemp-derived product as well as how and when the agency’s policies for certain CBD-containing products might change

Presenters:                                                                             

• Rich Cleland, Assistant Director, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission                                                             

• Shawn Hauser, Partner, Vicente Sederberg, LLP

• Will Woodlee, Partner, Kleinfeld, Kaplan and Becker, LLP / AHPA General Counsel