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Regulatory Assistance

When the FDA required one of the world’s largest dietary supplement companies to prove that a key ingredient was grandfathered in under DSHEA (Dietary Supplements Health and Education Act), they called Novel for help.  In a matter of hours, our in-house team of regulatory specialists delivered documentation going back nearly twenty years that proved the ingredient had, in fact, been sold prior to DSHEA’s enactment in 1994.