Area of focus

Medical Foods and Dietary Supplements

Medical foods and dietary supplements are technically foods, not drugs. But different rules around safety, labeling, and manufacturing apply. It can be challenging to keep up.

Certain foods and ingredients have been shown to be effective in managing disease and health related conditions and supporting overall well-being....

Representative experience

Represented dietary supplement companies in successfully responding to FTC inquiries on nutrition-related claims, resulting in closure of the investigations or consent orders to resolve threatened enforcement.

Assisted clients in developing health claim petitions that would authorize the use of various health claims on dietary supplements and conventional foods.

Successfully represented several importers of dietary supplements and other products in obtaining release of FDA-detained shipments, enabling the importation of commodities and minimizing marketing disruptions.

Conducted due diligence investigations for companies subject to takeover or merger activity, assisting with identifying serious regulatory deficiencies to stop a company from acquiring another’s problems.

For dietary supplement companies planning to undertake clinical research, we are providing counsel as to whether Investigational New Drug (IND) applications are required or prudent.

Counseled dietary supplement and other companies on product classification issues and the regulatory pathway (e.g., food, dietary supplement, medical food, drug) most likely to meet desired objectives.

Helped clients assess the status of proposed claims and ingredients (especially new dietary ingredients) and prepare any necessary notifications to the FDA.

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