We frequently receive inquiries about what steps are required to launch a dietary supplement, sell a raw material or functional food into the U.S. marketplace. LDI Group has created a new client checklist of issues which require evaluation before a foreign company should launch a dietary supplement or functional food into the U.S.

LINKS
LDI Group maintains a worldwide network of affiliates and alliances to better serve our clients. We recommend the following organizations and websites as qualified and reliable sources of information, education and industry news on dietary supplements and functional foods :
NEW CLIENT CHECK-LIST
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1. Regulation requirements
o Confirm ODI/NDI status under DSHEA.

o If an NDI, prepare and file NDI submissions to FDA.

2. Confirm nutrition content, or, for non-nutrients:
o Confirm all ingredients by plant species, identity or other means.

o Evaluate strength, purity, potency and identity of all ingredients.

o Evaluate stability and shelf-life in the proposed dosage form.

o Evaluate safety data under the proposed conditions of use.

o Establish whether the substance is GRAS affirmed or an approved food additive.

o Review the proposed label format.

o Review and develop structure/function claims as appropriate.

o Review and develop labeling and advertising claims which are subject to FTC regulation and policies.

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