HPM advises clients on regulatory requirements applicable to food products, including conventional foods, medical foods, dietary supplements, food and color additives, food contact substances, and novel food ingredients.

Labeling & Advertising

We help evaluate, develop, and if necessary, defend, food labeling and advertising. We help clients with issues such as:

  • Health claims
  • Nutrient content claims
  • Nutrition labeling
  • Structure/function claims
  • “Non-GMO” and “natural claims”

Ingredients

We advise on the regulatory status of specific ingredients for use in foods and dietary supplements, and help develop global regulatory strategies for the introduction of new food ingredients. HPM helps clients prepare:

  • Generally recognized as safe (GRAS) self-determinations
  • GRAS notifications
  • Threshold of regulation exemption petitions for indirect food additives (including food packaging materials)
  • Color additive petitions
  • Food contact notifications
  • New dietary ingredient notifications

Dietary Supplements

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. We advise clients on:

  • Statements of nutritional support and other labeling for dietary supplements
  • Good manufacturing practice requirements
  • Requirements applicable to dietary ingredients and new dietary ingredients

Food Safety Modernization Act

We advise on interpretation and implementation of the FDA Food Safety Modernization Act of 2011 and its implementing regulations, including those pertaining to current good manufacturing practices and preventive controls for human and animal food, foreign supplier verification program requirements, produce safety, and sanitary transportation.

Bioterrorism Act

We 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.

To view the range of enforcement and advertising matters frequently handled by our attorneys, click on Enforcement and Advertising and Promotion

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