Today, food and color additives are more strictly studied, regulated and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition.
When evaluating the safety of a substance and whether it should be approved, FDA considers: 1) the composition and properties of the substance, 2) the amount that would typically be consumed, 3) immediate and long-term health effects, and 4) various safety factors. The evaluation determines an appropriate level of use that includes a built-in safety margin – a factor that allows for uncertainty about the levels of consumption that are expected to be harmless. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect. Because of inherent limitations of science, FDA can never be absolutely certain of the absence of any risk from the use of any substance. Therefore, FDA must determine – based on the best science available – if there is a reasonable certainty of no harm to consumers when an additive is used as proposed.
If an additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used, and how it should be identified on food labels. In 1999, procedures changed so that FDA now consults with USDA during the review process for ingredients that are proposed for use in meat and poultry products. Federal officials then monitor the extent of Americans’ consumption of the new additive and results of any new research on its safety to ensure its use continues to be within safe limits.
If new evidence suggests that a product already in use may be unsafe, or if consumption levels have changed enough to require another look, federal authorities may prohibit its use or conduct further studies to determine if the use can still be considered safe. Regulations known as current Good Manufacturing Practices (cGMP) limit the amount of food ingredients used in foods to the amount necessary to achieve the desired effect.
In 1997, the Food and Drug Administration Modernization Act (FDAMA), amended the Food Drug and Cosmetic Act (FD&C Act) to streamline the way in which the FDA conducted business. One of the new procedures established to accomplish this goal was a notification process for food-contact substances. The amended FD&C Act (United States, 1998a) defined a food-contact substance as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.”
This notification process is intended to replace the petition process as the primary means for authorizing new uses of food additives that are food-contact substances. However, discretion is given to the FDA for deciding when the petition process is more appropriate for evaluating data to provide an adequate assurance of safety.
The FDA attorneys and consultants of C. Humphrey & Associates, P.A. represents domestic and international companies who manufacture and utilize Food Ingredients and Food Packaging. Our FDA law firm provides regulatory representation regarding a range of regulatory food law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of food ingredient and food labeling matters.
Our FDA law firm counsels clients regarding compliance with a variety of statutory and regulatory requirements and guidance documents covering Labeling and Food Packaging including:
- Packaging Materials Evaluations
- FDA Approval Processes (Food Contact Notifications; Food Additive Petitions; GRAS Evaluations & Notices)
- Development & Implementation of Compliance Strategies
- Analysis of Compliance Deficiencies
- Labeling Review & Compliance
- Crisis Management
- FDA Inspection Preparation
- FDA Import Alerts
- Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls
- Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA criminal and civil penalties)