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August 4, 2011
SALT LAKE CITYFDAs New Dietary Ingredient (NDI) Draft Guidance shakes up what is considered a dietary ingredient, at least in the minds of some product manufacturers. Concern over the status of probiotics and synthetic botanicals have had some questioning if their products are considered dietary ingredients, food additives or GRAS (generally recognized as safe) ingredients.
To help cut through some confusion, Claire L. Kruger, Ph.D., D.A.B.T., SPHERIX, outlined the differences in GRAS, dietary and food additive ingredients at the United Natural Product Alliances (UNPA) seminar on the NDI Draft Guidance.
An ingredient can get into the diet by being a food, food additive, drug, dietary supplement or a GRAS ingredient, she explained. The way that ingredient is used and what the finished product marketer says about it determines which category it goes into. One ingredient could go into many buckets depending on product use and marketing claims.
GRAS ingredients are intended to become a component of food. They must have general recognition of safety based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. GRAS ingredients are supported by either scientific procedures or common use in food prior to January 1, 1958. As Kruger put it, GRAS is summary of good, bad, ugly," meaning companies need to account for all available evidence, positive or negative.
GRAS requires the same safety standard as food additives, i.e., a reasonable certainty of no harm. However, unlike a food additive, the Information must be publically available. For GRAS determination, a history of consumer exposure is required, and the product labeling cant limit intake by amount or population. The intended effect or functional use also needs to be outlined in a GRAS determination.
GRAS status was a carve out of food additives group that was created in the Food Additives Amendment of 1958. In 1997, legislation allowed GRAS status to be self-determined, taking it out of the premarket-approval process. Before this, a company needed to petition FDA; however, this process caused GRAS petitions to back log in FDA offices. Companies would sometimes have to wait years to get approval.
Post-1997, companies can still petition FDA, but it is not an approval process. Once a company self-affirms an ingredient as GRAS, it can send it to FDA for review. FDA can then issue a non objection" or an objection" to the GRAS status of an ingredient.
Food additives also become a component of food, but they require premarket approval. The research on food additives dont have to be publically available or acceptable. Like GRAS, food additives cannot exclude sub populations or limit intake.
Dietary ingredients supplement the diet and were legally created with the Dietary Supplement and Health Education Act of 1994 (DSHEA). Dietary supplements are not subject to premarket approval, but do require premarket notification with a 75-day review period. Dietary ingredients can limit intake by amount and population on the label. The safety data on dietary ingredients dont need to be publically available or accepted, but DSHEA said the safety needs to be reasonably expected to be safe under the conditions used in the labeling."
The categories can seem clear, but some ingredients, such as probiotics, that industry considered a dietary ingredient may fall into the food additive category, according to the Draft Guidance. Regarding probiotics, Kruger said its up to product manufacturers to prove they were in the diet of man before they were isolated as an ingredient and used in a dietary supplement or as a GRAS ingredient. If not, they are considered food additives, she said.
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