This notification must be presented to FDA at least 75 days prior to the marketing of a dietary supplement containing such ingredients. FDA has been reviewing these notices within 90 days of receipt and responds to the submitter if the data submitted is insufficient or non-compelling. This is a list of most, not all, of the botanicals and botanically derived substances submitted by industry as new dietary ingredients to the FDA since October 1994. Evening primrose seed oil, expressed from the seed, has been sold in the U.S. before 1994. Presumably, the manufacturer submitting this ingredient based the submission on the fact that an extract is chemically distinct from the expressed oil.
Oleander is a plant containing cardioactive glycosides.
The company submitting this to the FDA claims to have produced a nontoxic extract. Inc. He had 30 years of Food and Drug Administration experience before joining the staff of AAC in 1994. He has been influential in developing AAC into one of the nation s leading regulatory consultants to the dietary supplement industry. AAC Consulting Group, Inc., provides support and assistance to companies whose products are regulated by the Food and Drug Administration, including those in the dietary supplement industry. The Bethesda, Maryland, consulting firm is staffed with former FDA compliance and inspection officials.