3) Percentage of your gross sales generated by the following types of operations
Your Product Sales
Annual Gross Sales - Upcoming Year
Annual Gross Sales - Current Year:
Annual Gross Sales - First Prior Year:
Annual Gross Sales - Second Prior Year:
Annual Gross Sales - Third Prior Year:
9) Percentage of total gross sales generated by the following types of products (if none, enter 0)
a. For use by children
b. Caffeine exceeding 300 mg per serving (all sources)
c. Animal & vet supplements
d. Sports nutrition - bodybuilding, muscle enhancement supplements
e. Weight loss supplements
f. Sexual enhancement supplements
g. Cannabidiol (CBD)/hemp products
NOTE: Coverage will not apply to products containing ingredients banned by the FDA, including but not limited to Steroids, including any product, supplement, additive, substance, ingredient or compound controlled or banned by the Anabolic Steroid Control Act of 1990 including amendments thereto, or the Anabolic Steroid Control Act of 2005; DMAA (Dimethylamylamine) (1,3 - Dimethylamylamine); Ephedra; Ephedrine Alkaloids; or Fenfluramine (N-Nitroso-Fenfluramine).
YOUR QUALITY CONTROL AND REGULATORY COMPLIANCE
10) Product Withdrawal/Product Recall:
11) Current practices or your specified industry equivalent:
12) Quality Assurance Program (QAP)/Quality Control Program (QCP):
Optional Coverage Enhancements
Your Claims, Losses, Demands for Damages and Similar Experience
I/We declare that I/We have reviewed this Application for accuracy before signing it, that the above statements and representations are true and correct, and that no facts have been suppressed or misstated. I/We understand that this is an application for insurance only and that the completion and submission of this Application does not bind the Company to sell nor the applicant to purchase this insurance. I/We nevertheless acknowledge that any contract of insurance issued by the Company in response to this Application will be in full reliance upon the statements and representations made in this Application.
Any person who knowingly and with intent to defraud any insurance company or other person, files an application for insurance, or statement of claim containing any materially false information or conceals for the purpose of misleading, information concerning any material fact, commits a fraudulent insurance act, which is a crime and may also be subject to civil penalty.
I/We hereby declare that the above statements and particulars are true and I/We agree that this Application shall be the basis for any contract of insurance issued by the Company in response to it.
Certain terms are abbreviated in this application. Here are a few:
- FDA means the United States Food and Drug Administration
- FDCA-21CFR Part 11 means Food Drug and Cosmetic Act
- FTC means the United States Federal Trade Commission
- QAP / QCP means Quality Assurance Program / Quality Control Program
- SOP means Standard Operating Procedure
- cGMP / GMP means Current Good Manufacturing Practices / Good Manufacturing Practices
- Cannabidiol (CBD) is a nonpsychoactive ingredient found in plant species cannabis sativa Prop 65 refers to the Safe Drinking Water and Toxic Enforcement Act of 1986
For detailed information on regulatory requirements and definitions, you may find useful references at www.fda.gov and www.ftc.gov.