Foods and Dietary Supplements
HPM's practice includes advising and assisting marketers of conventional foods, medical foods, dietary supplements, food and color additives, food contact substances, and novel food ingredients in complying with the regulatory requirements for these products and their components.
HPM attorneys provide assistance in evaluating, developing, and if necessary, defending, labeling and advertising for conventional foods, medical foods, and dietary supplements. We assist clients with issues such as:
HPM was involved in the Congressional debates and enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), and closely follows FDA's implementation and enforcement of the requirements of this amendment to the Federal Food, Drug, and Cosmetic Act, as well as the implications of these developments for the regulation of other types of foods and food ingredients.
- Health claims
- Nutrient content claims
- Nutrition labeling
- Statements of nutritional support and other labeling for dietary supplements
HPM assists clients in the preparation of:
HPM attorneys advise on the regulatory status of specific ingredients for use in foods and dietary supplements, and assist in the development of global regulatory strategies for the introduction of new food ingredients.
- Generally recognized as safe (GRAS) self-affirmations
- GRAS affirmation petitions
- GRAS notifications
- Food additive petitions for direct and indirect food additives (including food packaging materials)
- Threshold of regulation exemption petitions for indirect food additives (including food packaging materials)
- Color additive petitions
- Food contact notifications
- Notifications of "new dietary ingredients" for dietary supplements
HPM attorneys advise food and dietary supplement companies on compliance with the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, including facility registration, prior notice for imported products, administrative detention, and recordkeeping.
A. Wes Siegner, Jr.