LEGAL SERVICES – MENU OF SUPPORT OPTIONS
Our Firm offers several levels of legal services support for your health and wellness business or practice. How would you like to be supported?
We will review dietary supplement or cosmetics products of Client at a flat fee of $2,500 per product.
The review will include the following, which are the most commonly requested legal services for a Dietary Supplement or Cosmetics Product:
- 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.
(Estimated Value: $1,500)
- Review of Your Claims: We will review your claims for potentially unlawful disease claims. The review will include:
- Review of claims on:
- 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 first website product page (but not additional testimonial pages).
- Research of some relevant FDA warning letters.
- Review of claims on:
(Estimated Value: $3,000)
- 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.
(Estimated value: $3,000)
- Discussion with You: Up to one full hour of discussion of our findings and recommendations with you.
(Estimated Value: $500)
(Total Estimated Value: $8,000)
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.
- Compliance with current Good Manufacturing Practices (cGMPs)
- 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 be happy to do more work for you or with you, in a way that best supports you, at usual hourly rates. Note: 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.
We will provide the following legal services at a flat fee of $10,000.
The review will include the following, which are the most commonly requested legal services for Healthcare Ventures:
- Review of Regulatory Issues affecting your business structure: We will review the key regulatory issues affecting your business structure (such as Stark, anti-kickback, fee-splitting, Medicare and other third-party reimbursement, program fees, etc.) and advise on more compliant ways to structure your venture.
(Estimated value at hourly rates: $3,000 – $6,000.)
- Written Report. The Written Report, in the form of a confidential memo to you, will contain:
- Identification of key regulatory issues and obstacles.
- Compliance recommendations.
- Legal strategies and solutions to protect and support your venture.
(Estimated value at hourly rates: additional $4,000 – $6,000.)
(Estimated value at hourly rates: $5,000 – $7,500.)
- Discussion with You: Up to three hours of discussion of our findings and recommendations with you.
(Estimated value at hourly rates: $1,500.)
Total estimated value: $13,500 – $21,000
We do not include corporate formation and related documents, employee handbooks, merger agreements, or other documents outside the above scope. As well, we will not exceed 25 attorney hours of work; we will be happy to do more work for you, in a way that best supports you, at usual hourly rates.
The Gold plan (one-time payment of $7,500 or 3 payments of $2,500 monthly over a Term of 3 months) gives you up to 18 hours of access to Attorney time, including phone calls and emails/responses to emails, legal research and analysis, and drafting and written reviews. The normal cost for Partner-level time at this level of support would be approximately $9,000. You can use the block of hours anytime during and over the 3-month period. Please see our Automatic Renewal Disclosure, if you sign up for an automatic renewal of the Gold Plan.
The Platinum plan (one-time payments of $15,000 or 3 payments of $5,000 over a Term of 3 months) gives you up to 50 hours of access to Attorney time, including phone calls and emails/responses to emails, legal research and analysis, and drafting and written reviews. The normal cost for Partner-level time at this level of support would be approximately $25,000. You can use the block of hours anytime during and over the 3-month period. Please see our Automatic Renewal Disclosure, if you sign up for an automatic renewal of the Gold Plan.