In the complex and evolving landscape of food and dietary supplement regulation in the United States, understanding the intricate details of regulatory classifications and notification processes is crucial for manufacturers, distributors, and consumers alike. ILDONG Bioscience is at the forefront of navigating these regulatory pathways, ensuring the highest standards of safety and quality for its products. This commitment is further bolstered by our partnership with Nutralliance, a trusted exclusive distributor known for its dedication to distributing premium quality ingredients.
Regulatory Classifications and Notification Processes in the US
The US regulatory framework for food and dietary supplements is governed by the Food and Drug Administration (FDA), which sets stringent guidelines to ensure the safety and efficacy of products entering the market. Key among these regulations are the Generally Recognized as Safe (GRAS) status, New Dietary Ingredient (NDI) notifications, and Self-Affirmed GRAS determinations. Each of these pathways serves a unique purpose in the regulatory landscape, guiding manufacturers and distributors in the compliance process.
FDA GRAS
The GRAS status is a designation that a substance added to food is considered safe by qualified experts, and therefore, is exempt from the conventional food additive tolerance requirements set by the Federal Food, Drug, and Cosmetic Act (FFDCA). To achieve GRAS status, there must be a consensus among scientific experts about the safety of the substance for its intended use, based on a history of safe use or new scientific evidence.
The FDA offers a voluntary notification program where companies can submit a GRAS notification for the agency's evaluation. This process involves a rigorous review of scientific data and information to ascertain the substance's safety. However, companies also have the option to determine GRAS status internally, without FDA notification, by conducting a comprehensive evaluation of the substance's safety through qualified experts.
Self-Affirmed GRAS
In instances where a company opts not to submit a GRAS notification to the FDA, it may still make a Self-Affirmed GRAS determination. This self-affirmation process requires the company to conduct an extensive review of the substance's safety, akin to the evaluation process for an FDA GRAS notification. The review must be carried out by qualified experts who conclude that the substance is safe for its intended use based on a thorough examination of scientific evidence.
While the Self-Affirmed GRAS process does not involve direct FDA review or approval, it mandates the same rigorous level of scientific evidence to support the safety of the substance. This ensures that companies maintain the responsibility for the safety of their products, adhering to the highest standards of consumer safety.
FDA NDI
For dietary supplements, the introduction of new dietary ingredients (NDIs) that were not marketed in the United States before October 15, 1994, requires pre-market notification to the FDA. The NDI notification process is designed to ensure that new ingredients are safe for consumers before they are introduced into the market. Companies must provide evidence that supports the safety of the dietary supplement containing the NDI under the recommended or suggested conditions of use on the labeling.
This process highlights the FDA's commitment to safeguarding public health by closely scrutinizing new ingredients for safety before they are available to consumers. It underscores the importance of continuous research and innovation in the dietary supplement industry, ensuring that new products meet rigorous safety standards.
Aspect | FDA GRAS | FDA NDI (New Dietary Ingredient) | Self-Affirmed GRAS |
Definition | A status indicating a substance added to food is safe and exempt from food additive tolerance requirements. | A dietary ingredient not marketed in the US in a dietary supplement before October 15, 1994, requiring notification before marketing. | A determination by a manufacturer or supplier that a substance is safe, without FDA notification. |
Process | Submission of GRAS notification to the FDA for evaluation or internal determination without notifying the FDA. | Manufacturers or distributors must notify the FDA at least 75 days before marketing a dietary supplement containing an NDI, with evidence supporting safety. | An internal review by qualified experts to determine safety, without FDA submission. |
Regulatory Aspect | Can either involve the FDA through notification or be a company's internal determination. | Specific to dietary supplements; requires pre-market notification and evidence of safety. | Does not involve FDA review but requires a level of scientific evidence of safety similar to FDA GRAS notification. Companies are responsible for their product's safety. |
Evidence of Safety | Scientific evidence must be widely recognized by experts qualified by scientific training and experience. | Must include evidence that supports the safety of the dietary supplement containing the NDI under the conditions recommended or suggested in the labeling. | Requires comprehensive evidence of safety, similar to the GRAS notification process. |
Market Before Oct 15, 1994 | Not Applicable. | NDIs are ingredients not marketed in the US in a dietary supplement before this date. | Not Applicable. |
Food Additive Tolerance | Exempt from the usual Federal Food, Drug, and Cosmetic Act food additive tolerance requirements. | Not applicable directly, but safety must be demonstrated for dietary supplements. | Exempt, based on the self-determination of safety. |
Intended Use | Generally for substances added to food. | Specifically for dietary supplements. | Can be for substances added to food or dietary ingredients, based on the company's determination. |
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