We will review dietary supplement or cosmetics products of Client at a flat fee of $2,500 per product.

The review will include:

• Markup of Your Product Label: We will mark up your label to reflect key FDA and FTC labeling requirements for your supplement or cosmetics product.
• Review of Your Claims: We will review your claims for potentially unlawful disease claims.  The review will include:
  • The proposed label and packaging you send us.
  • The website product page you send us (one page, not including: pages included by hyperlinks, or videos).
  • The testimonials showing on the website product page (but not additional testimonial pages).
  • One website information page that you send us.
• Written Report.  The Report will contain:
  • Recommendations for compliance with FDA rules.
  • An overview of FTC substantiation requirements relevant to the product
  • A brief identification of ingredients that may be problematic or require research.
• Discussion with You: Up to one full hour of discussion of our findings and recommendations with you.

The review will not include the following items (as we expect that you will either task your team with working on these issues, or engage us at hourly rates per our Legal Services Agreement):

• Specialized compliance tasks:
  • A review of your proposed evidence, to assess substantiation.
  • Review of the legal status or safety of specific dietary supplement or cosmetic ingredients, or preparation of an NDI (new dietary ingredient) or another ingredient submission to FDA
  • Identification or analysis of customs/import issues, if any.
  • Preparation of the 30-day premarket notification to FDA for supplements.
  • If you are a cosmetics establishment, voluntary registration with FDA.
• A more comprehensive, super in-depth review of lots of marketing material:
  • Review of videos, video testimonials, or social media pages other than as indicated above.
  • Review of additional client amendments to labels and website or other marketing content.
  • Line edits on website or other marketing content.

Also, we do not include any other issues or types of review or analysis other than as indicated in what we will include.  FDA compliance is an ongoing project and as mentioned, we will happy to do more work for you or with you, in a way that best serves your needs.  Disclaimer: This fee structure is not a guarantee, warranty, or transfer of enforcement risk, and is subject to all other terms in our Legal Services Agreement.