Ingredient Reviews

Ingredient reviews are used to determine whether particular products, as currently formulated, may be legally marketed in the United States without further regulatory approval. Because some ingredients may only be used in products that are classified as drugs, it is important to know whether your formulation would cause your product to be regulated more stringently and require pre-approval.

Ingredient Reviews and FDA Regulations

Because the FDA typically regulates products based on both their ingredients and intended use, ingredient reviews are often the first stage in determining how products are regulated. In addition, under FDA regulations ingredients generally must be declared according to their common or usual name. These regulatory requirements are applicable to foods, dietary supplements and other FDA-regulated products. More information about FDA regulations pertaining to ingredient declarations may be accessed here.

Finally, it is important to note that certain ingredients must be listed separately in accordance with major allergen declaration requirements. These requirements dictate that major food allergens must be listed on all food and dietary supplement labels. Where major allergens are present and not listed according to the requirements under federal law, these products are deemed misbranded and may be subject to regulatory action.

Ingredient Reviews and FDA Regulatory Assistance

At Shehadeh Giannamore, PLLC, a FDA regulatory attorney can help you by conducting ingredient reviews, which typically entail the following:

  • Researching various FDA and related databases to determine marketing options for your product;
  • Determine whether it is feasible to market your product legally, as formulated;
  • Providing guidance with respect to the classification of your product based on the ingredients found therein, and
  • Helping you determine FDA-compliant ingredient declarations for use in your product labeling.