FDA Labeling Expert

Posted last week

Only freelancers located in the U.S. may apply.U.S. located freelancers only

Summary

TITLE: FDA Dietary Supplement Label Reviewer (US): Supplement Facts + Claims Compliance Check OVERVIEW: We're a functional chocolate brand launching in the US. Our products are dietary supplements: chocolate infused with nano-emulsified botanicals, made in India and imported by our US entity. We have 8 formulas across two product lines. We prepare our Supplement Facts panels and claims in-house and are looking for a credentialed US regulatory expert to review and validate them before we go to print. We're not looking for someone to build from scratch. We want a sharp second set of eyes who can certify we're compliant, catch what we've missed, and stay on as our go-to reviewer as we add products. WHAT YOU'LL DO: - Review and validate 8 Supplement Facts panels we've prepared, against 21 CFR 101.36, including proprietary-blend declarations - Review our structure/function claims for compliance (21 CFR 101.93) and confirm the required disclaimer language is correct - Advise on the FDA structure/function claim notification (the 30-day requirement) - Catch any label, ingredient, or formatting issues before print - Deliver a clear pass or fix-list per formula YOU'RE A FIT IF YOU HAVE: - A recognized regulatory credential (RAC strongly preferred) or an equivalent verifiable qualification: an advanced degree in regulatory affairs, food science, or a related field; a PharmD or regulatory law background; or direct FDA experience - Proven, specific experience with US dietary supplement labeling (not cosmetics, not EU food, not general "FDA experience") - Working fluency in 21 CFR Part 111 and Part 101 - Enough familiarity with nutrient-labeling standards and software (Genesis R&D, ESHA, or LabelCalc) to independently verify our panels - Clear, fast communication and a partnership mindset ENGAGEMENT: We'll start with a small paid trial: review one formula's panel and claims, and deliver a marked-up pass or fix-list. If it's a fit, we move to the remaining formulas and ongoing launch support, with room for a longer relationship as we add products. IN YOUR PROPOSAL, PLEASE ANSWER: 1. What is your regulatory credential or qualification, and can you verify it? 2. Have you reviewed FDA Supplement Facts panels for US dietary supplements before? Share an example of a panel or review you've validated (redacted is fine). 3. A vendor tells you a label is "FDA approved." How do you respond? 4. What's your rate, and roughly how long would it take you to review one panel plus its claims?

  • Less than 30 hrs/week
    Hourly
  • < 1 month
    Duration
  • Expert
    Experience Level
  • Remote Job
  • One-time project
    Project Type
Skills and Expertise
Mandatory skills
Regulatory Compliance
Activity on this job
  • Proposals:Less than 5
  • Last viewed by client:last week
  • Interviewing:
    1
  • Invites sent:
    4
  • Unanswered invites:
    3
About the client
Member since Jun 20, 2024
  • USA
    Bothell10:05 AM
  • $4K total spent
    12 hires, 3 active
  • 176 hours
  • Media & Entertainment
    Small company (2-9 people)

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