Dietary Supplements Ingredient and Labeling Compliance

Why Should You Attend:

• What is the risk exposure from product ingredients?
• What risks typically stem from labeling and marketing dietary supplements?
• How to distinguish conventional foods from liquid dietary supplements?
• What is the boundary between the FDA and the FTC?

The expansion of product offerings in the Dietary Supplements 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.

This webinar will cover 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. You will learn what claims are permissible, what constitutes a disease or drug claim, the implications of making impermissible claims and how to remedy challenged claims. We will also look at ingredient reviews and factors to distinguish conventional foods and liquid dietary supplements, like energy drinks.

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.
• Ingredient Review
• What is GRAS?
• When is Pre-market approval required?
• Factors to distinguish conventional foods, like sodas, from liquid dietary supplements, like energy or melatonin drinks.

Who will Benefit:

• Food & beverage industry executives
• Dietary Supplement manufacturers/distributors
• Medical Device manufacturers/distributors
• In-House Legal Counsel
• Regulatory Affairs
• Government Affairs
• Distributors and manufacturers
• Customs brokers
• FDA/Food & Drug Attorneys

Instructor Profile:

Marc Sanchez, represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues and is considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post.

For the food industry, Marc’s practice includes working with both the FDA and USDA on compliance, recalls, and import matters. His clients rely on his ability to equally balance market opportunity with risk exposure. The result is a philosophy that utilizes a client’s strengths in adapting to regulatory issues and market limitations. Marc’s strategy is to develop smart corporate governance along with regulatory compliance.

Marc is the founder of Contract In-House Counsel and Consultants, LLC. His firm utilizes a cost effective model of adding a contact in-house attorney to small and mid-sized companies to provide expert counsel on a short and long-term basis. He currently serves clients across the US, EU, China, and Middle East.

Topic Background:

Dietary supplements are a difficult category to manage. Products straddle a line between food and medicine, which can often lead to enforcement actions and recalls. Risk exposure typically stems from labeling and marketing or product ingredients. Claims that pass a boundary for treating or mitigating diseases and conditions lead to a “new drug” label and a big regulatory headache. It can also be difficult to understand where the boundary between the FDA and Federal Trade Commission lies. Ingredient reviews are also important to ensure a product is not deemed adulterated.

Follow us :