Agenda

Breakfast + Registration

Icebreaker

Chairperson’s Opening Remarks

Ronie Schmelz

Beauty from Within – Examining the Regulatory Concerns for Ingestible Skin, Hair, and Nail Boosting Supplements

Since ancient times, beauty and youthfulness have been linked, and vanity is not reserved for individuals of any age or gender. More and more people are concerned about such things as greying or thinning hair, wrinkles and sagging skin and brittle nails; so, the thought that these things can be restored to their “former glory” simply by taking a daily dietary supplement or sipping a “beauty beverage” is appealing to many. All of which explains why so many cosmetics and supplement companies are tailoring products to meet this growing consumer market. This session will take a look at the regulatory and compliance issues that arise when providing a product that claims to improve beauty from the inside out.

Diana Morgan

Diana Morgan is Head of Scientific & Regulatory Affairs for Care/of, a Direct-to-Consumer, Personalized Nutrition manufacturer. She is a passionate wellness advocate and nutritionist who has served in the industry almost 15 years, having held previous roles at Pfizer Consumer Healthcare, The Vitamin Shoppe headquarters and Solgar Vitamin & Herb, a Nature’s Bounty company. In […]

Stan Soper

SVP, International & Chief Legal Officer | Nutraceutical Corporation  

Improved Labeling Compliance: Strategies for Identifying, Avoiding and Resolving Labeling Mistakes

Labeling has never been stricter nor have consumers ever been so knowledgeable about ingredients. This means companies need to be more aware of how their products are marketed to ensure compliance. This interactive panel will review best practices as to how cosmetics, personal care and supplement companies can ensure compliance in their labeling practices.We will:

  • Examine new regulations and strategies to avoid and resolve labeling mistakes
  • Understand how to implement mandatory labeling changes effectively and quickly to correct labeling errors
  • Determine how marketing can help during the labeling process

Jeff Brams

Garden of Life, LLC. (GoL) is a division of Nestlé Health Sciences (NHSc) and is the leading supplement and nutrition brand sold online and in the Healthy Foods Channel (VMS). GoL is uniquely focused on traceability with more 3rd Party Certified products than any other brand, including USDA Organic, Non GMO Project Verification, NSF Full-Label, […]

Lacey Act Compliance and Supply Chain Transparency – Do you have a Compliance Program?

The Lacey Act is the oldest wildlife protection statute in the United States.  It was originally enacted in 1900 to protect animal species.  In 1981, Congress expanded the Lacey Act to cover certain plants and plant parts taken in violation of US domestic law, but not foreign law.  In 2008, Congress substantially expanded coverage of the Lacey Act to include all types of plant (including lumber, wood and other plant products – including essential oils and other natural products) and animal materials.  The 2008 Amendment was the first ban on wood and plant products that sought to target illegal harvest outside the United States, and to provide better transparency into the source and species of plant and wood products being imported into the United States.  This session will discuss how this US statute affects industries utilizing plant ingredients/constituents in finished products and the push for supply chain transparency. Key points include:

  • Background on the Lacey Act and prohibitions
  • Application to natural products industry and due care standards
  • Looking ahead and approaches to developing a quality compliance program

Jessica Harris

International Trade Compliance, Young Living

Networking Break

Understanding Claims Substantiation and How Social Media Influencers & Claims Can Impact You

In today’s digital world, companies have even more marketing and advertising platforms than ever before; and social media outlets have given rise to influencers, paid promoters and celebrities using their voice to speak out on many products. In addition, companies that utilize distributor networks to market and sell their products have a larger reach than ever before through the use of social media. These individuals tend to have a lot of weight to consumers who rely on product assessments and reviews before making a purchase. In this session we will examine how to utilize these influencers and paid promoters while following the FTC regulatory guidelines. We will discuss topics such as:

  • How to create an effective marketing strategy using social media, YouTube channels and more
  • Develop ways to prevent or counteract trolls, fake review by competitors or other adverse and negative marketing
  • Examine the FTC guidelines on influencer marketing on social media including the use of hashtags
  • Understand the impact of FTC warning letters for distributors, influencers and paid promoters in social media
  • Create a policy for distributors and influencers/promoters to eliminate the potential for problems
  • Examine regulatory and compliance liability concerns as they apply to social media
  • Learn how to utilize technology to monitor your company’s/brand’s name across social media platforms

Alyse Aruch

Alyse Aruch is Senior Corporate Counsel at Pfizer, Inc. where she acts as Global Products Counsel supporting a large portion of the Consumer Healthcare Portfolio, including cosmetics, dietary supplements and monograph drug products. Ms. Aruch counsels internal clients regarding new product launches, claims, advertising campaigns and interaction with social media influencers.

Christin DeLorme

Christine is an attorney in the FTC Division of Advertising Practices, where she investigates false and deceptive and national advertising and has particular Advisor to experience former FTC in Chairman evaluating Jon scientific Leibowitz, substantiation former Commissioner for health Terrell claims. McSweeny, Since joining and the Commissioner FTC in 2004, Christine Rebecca also Kelly has […]

Neshat Soofi

Neshat Soofi is the Head of Product Safety, Quality & Integrity at Brandless Inc., an e-commerce company that manufactures and sells food, personal care, and household products under its own Brandless label. Brandless was brought to life on July 11, 2017 with the intention of offering better-for-you products at simple, fair prices. One of the […]

Interactive Breakout Discussions

 

Examine High Impact Tools for Cosmetics Companies to Advance Regulatory Harmonization25 Years and Counting -- Revisiting DSHEAExamining New Sunscreen RulesInterpreting the USDA National Bioengineered Food Disclosure Law

Lunch

Cosmetics Breakout Session

Exploring Cosmetics’ Chemical Concerns
Some ingredients in cosmetics and personal care products are chemicals that can be hazardous to consumers’ health. Many organizations such as the EWG, European Commission, EU REACH, the EU Cosmetics Regulation, CIR, TSCA, Green Chemistry, International Fragrance Association, are evaluators of cosmetic products, but there are many, many more that need to be navigated. Cosmetic companies can save millions of dollars, if they are able to identify what chemicals or ingredients might create issues for them before using them. In this session, we will:
  • Examine various chemical concerns being faced by the cosmetics and personal care products industry
  • Discuss product contamination or concerns
  • Determine how companies are doing multiple product testing to ensure products meet standards
  • Identify various international regulations and how they may affect your brand – ie. animal testing with chemicals
  • Explore alternative ingredients can be used to banned products or to avoid problems
  • Identify what ingredients consumers are (or are not) looking for in their products

Rebecca Hamilton

Rebecca Hamilton is a second generation owner and co-CEO (Collaborative Executive Officer) at Badger, a natural and organic personal care products manufacturer known for its unique company philosophy, pioneering family-friendly benefits, and B Corp community engagement. In addition to her role as Co-CEO, Rebecca leads new product innovation and development, companywide quality assurance and regulatory […]

Supplements Breakout Session

Reducing Risk of Product Adulteration in the Supplement Industry
There have been many cases of adulterated supplements containing pharmaceuticals and products that may be harmful to consumers. Frequently adulterated supplements include those focused on weight loss, bodybuilding sexual enhancement amongst others. Manufacturers and brands within the supplement industry need to do all that they can to reduce the risk and problems that come with product adulteration. In this session we will discuss tips and practices to avoid product adulteration.

The Farm Bill Has Been Passed: How will Federal Refinement of Rules & Regulations for CBD and Hemp Oil Affect the Cosmetics, Personal Care Products and Dietary Supplements

A lot of consumers are starting to view CBD more like a vitamin, because it has been said to contain many vitamins and fatty acids and even possess anti-inflammation properties. And many cosmetics companies are exploring how to include CBD in their products. However, it is still a relatively new, unexplored and undocumented product/ingredient; in addition, there is so much uncertainty as to how it can and will be regulated. In this session, we will:

  • Reviewing the impact of the Farm Bill on hemp products that contain CBD’s
  • Interpreting the FDA laws and regulations that govern cosmetics and applying them to hemp and CBD products, in light of the pronouncements of the FDA Commissioner following passage of the Farm Bill
  • Understand the current risk hierarchy of CBD and Hemp Oil
  • Examine how states are navigating compliance as it relates to the massively scaling CBD industry
  • Explore why many cosmetic companies are and should be interested in the use of CBD in their products
  • Examine current case law related to the manufacturing and distribution of CBD
  • Determine if it is possible for CBD products to truly be free of THC

Ronie Schmelz
Daniel Malman

Chief Risk Officer, Integrated CBD, LLC

Rachael Pileggi

Assessing Clean, Green, Natural and non-GMO: Examining the Regulatory Soundness and Potential Liabilities for the Beauty & Supplements Industry

As the market continues to evolve, buzz words like “clean”, “green”, “natural”, “non-GMO”, “vegan”, “anti-cruelty” become that much more important to beauty and supplement brands and manufacturers to meet consumers demands for a healthy lifestyle. However, this has caused cosmetics, supplement and functional food companies a variety of headaches as they try to understand and navigate the new challenges that using these terms create. In this session, we will look into such things as:

  • Understanding what the implications and risks associated with labeling supplements, cosmetics and personal care products as “natural”
  • Examining the status of the new labeling requirements, and assessing whether your company is ready for the compliance deadlines
  • Understanding new regulations requiring labeling for bioengineered products
  • Analyzing the use of claims with ambiguous or changing definitions, such as “natural” and “healthy”, as well as interpreting FDA’s current position on these terms
  • Assessing the challenges with labeling products as preservative-free and natural or vegan, gluten free, peanut free, etc.
  • Deciphering the current standard for USDA requirement for “organic” and how does this apply to cosmetics and supplements?
  • Lessons learned from FDA requirements for natural versus synthetic flavors and how the cosmetics & supplements industries adapt to these standards

Tracey Barth
Paul Konney

Paul E. Konney is Executive Vice President, General Counsel & Head of Global Regulatory Affairs at Metagenics, Inc. in Aliso Viejo, CA. Mr. Konney received his bachelor’s degree with honors from Harvard University and his law degree from the University of Pennsylvania, where he was an officer of the Law Review. Following law school, Mr. […]

Kristi Wolff

Kristi Wolff’s practice focuses on food, drugs, dietary supplements, medical devices, personal care and consumer health products, as well as wearable technology and health privacy issues.  She has extensive experience advising clients whose products are within the overlapping jurisdictions of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Kristi handles matters […]

Networking Break

Collagen Infused Products: Is Enhancing Skin Elasticity and Bone Quality Creating Confusion?

This session will take a look at how collagen enhanced foods, beverages and health care products are creating confusion in terms of marketing claims and consumer usage. 

Waleed Gamay

Crisis Management: You’ve Received a Warning Letter, Now What?

A warning letter from the FDA or FTC is basically an instruction cease & desist whatever conduct they think is necessary until you can show compliance with regulations. Common reasons for warnings are misbranding, mislabeling, noncompliance with quality manufacturing procedures, product adulteration, and more. This session, will walk through what can and should be done upon receipt of a warning letter. We will look at things such as:

  • Understanding the various reasons for a warning letter
  • Determining the thin line between compliance and noncompliance
  • Discussing the need for an FDA/FTC lawyer
  • Examining practical solutions that help you comply respond to the warning and continue in business
  • Communicating changes to customers to not only stay in compliance but to repair or retain brand reputation

Varsha Nainani

Corporate Vice President Quality & Regulatory | Dhaliwal Laboratories  

The World is at Your Fingertips: Determine Which National and Global Markets are Best & Easiest to Enter and Methods to Ensure Compliance in Marketing to these Markets

This interactive panel discussion will share insight from leaders in the dietary supplements and cosmetics industries as to which markets are currently on the leader-board for product expansion. As we look at markets such as Japan, Korea, Brazil, China, and across the Americas and more, we will try to determine why these markets make sense, potential obstacles to be faced in each market and manners to secure marketing compliance in each market.

Martine Bertrand

Customs Compliance Manager at Sephora Beauty Canada

Debbie Laverty

Debbie Laverty, Director of Regulatory Affairs & Americas R&D, has been with Amway since 2004 and is currently reporting to the Vice President of Technical Regulatory Affairs and Quality Assurance.  Prior to this role, Debbie has held a variety of leadership positions within Regulatory Affairs covering all business lines, including a 3-year assignment in California […]

Chairperson’s Closing Remarks

Ronie Schmelz

Cocktail Reception

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