Dietary Supplements Labeling - Avoiding Claims that Invite Scrutiny and Penalties

Why Should You Attend:

One of the most common citations made against dietary supplement companies stands in the claims made in labeling and marketing materials. Claims that pass a boundary for treating or mitigating diseases and conditions lead to a “new drug” label and a big regulatory headache.

This session will discuss how dietary supplement companies should label their products for the US market per FDA requirements, considerations to avoid claims, building regulatory compliance into company programs for development and launch of properly labeled dietary supplements. Attend this webinar to learn what claims are permissible, what constitutes a disease or drug claim, the implications of making impermissible claims and how to remedy challenged claims.

Areas Covered in the Webinar:

• Dietary Supplement labeling.
• FDA requirements for Principal Display Panel.
• FDA requirements for Supplement Facts box.
• Other statutory and regulatory labeling requirements.
• Types of dietary supplement claims.
• Unqualified health claims.
• Qualified health claims.
• Structure-Function claims.
• Nutritive value claims.
• Claim substantiation.
• Clinical and nonclinical studies.
• Truthful and non-misleading advertising.
• FDA and FTC standards.

Who will Benefit:

• Food & beverage industry executives
• Dietary Supplement manufacturers/distributors
• In-House Legal Counsel
• Regulatory Affairs
• Government Affairs
• Distributors and manufacturers
• Customs brokers
• FDA/Food & Drug Attorneys
• Packaging and labeling service providers/ manufacturers
• Marketing, advertising and content professionals

Instructor Profile:

Marc C. Sanchez, practices medical device and food law and is best known for working to build regulatory strategies for start-up and small to midsize companies in the US, Europe and China. His educational and work portfolios are rooted in law and business management. He began his career with the legal division at Nike’s European headquarters, heading up product recalls, pricing and digital privacy in the EU, US, China and Japan. He later began his own practice in Seattle, focusing on product recalls, regulatory compliance and employment law.

In 2011, Marc founded Contract In-House Counsel and Consultants, LLC to offer a broad range of services to the medical device and food industry. He currently serves clients across the US, EU, China and Middle East. Marc received a masters in international commercial policy from Valparaiso University and earned his JD from Lewis and Clark College. He is a member of the Washington Bar Association and the Regulatory Affairs Professionals Society.

Topic Background:

Dietary Supplements are one of the fastest growing food product categories in the United States, especially with a growing number of consumers seeking natural and holistic remedies. While the product category was created and defined by Congress, the US Food & Drug Administration (FDA) has the authority to oversee claims and labeling of dietary supplements. The expansion of product offerings in this category has been met by an increase in FDA monitoring and enforcement. It is therefore important for dietary supplement companies to ensure their product labels and accompanying claims are fully compliant with applicable statutes and regulations.

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