Help Me Comply with FDA regulations
Donation protected
Dear friends, new and existing,
My name is Denise Joy, and for more than 30 years I have run Mountain Spirit Herbals. Making medicine has been my passion since learning many years ago from my grandmother, who was the 3rd in a lineage of herbalists. In the last 30 years, I have built a business on selling high quality medicinal herbal products to the public.
Now, my ability to continue to make these products is threatened. The Food and Drug Administration (FDA) has taken to surfing the internet to find small business owners like me in an effort to force us to match the standards of pharmaceutical drug companies. In essence, they put me through the harrowing process of a drop-in visit, with multiple follow-up visits, during which time they informed me that I cannot continue to do business in the same way I have been. This in spite of the fact that never once has a complaint been made about my products, nor has any been found to be tainted, or to have caused harm to anyone.
My business is a sole proprietorship. I make, package and market nearly every item in my catalog myself. I take pride in the quality of my products. The herbs which form the basis of every product are grown organically or wildcrafted by myself whenever possible; otherwise I purchase only high quality organic and wildcrafted herbs, oils and other products from respected vendors. My emphasis is on small batch processing, ensuring the best possible product.
At this point, the FDA is insisting I make major changes to my business including at a minimum relabeling, changes in marketing and advertising, and extensive documentation on every product for every batch made.
They are treating me as a drug company even though I am careful always to stress that these are traditional uses for herbs and that a certified health practictioner should be consulted before use. At this point, I have not been given a deadline by when I must comply, but I am being told that it is necessary to do this as quickly as possible, preferably within a year.
This is my livelihood as well as my passion. To create herbal medicine that helps those in need is what I do best! I truly want to continue doing this in my life, but at a cost of an expected $20,000 over the next year, I don’t know if I can without your help. Costs will include:
--lawyer fees. I have found an excellent lawyer who specializes in helping small businesses like mine work with the FDA successfully. I will need to be reclassified as a non-drug entity, among other things
--consultant fees. I am looking for a consultant who can help me ensure that I am in compliance with the FDA rules
--development and printing of procedure manuals
--graphic designers to redesign all labels
--website fees for modification of the website
--catalog rewrite and reprinting fees
--loss of business costs. I expect that I will have to significantly change some products. Others will be relabeled and marketed differently, so clients will not know what they are. Some of my best selling products have been specifically targeted by the FDA. Additionally, I may have to take down my website for a period of time in order to make changes. The website represents a major portion of my business income
Why should you help me?
--If my products have helped you or a family member, this will help ensure they will be available to you for years to come!
--If you have never used my products, then consider whether it is important to you to have high quality alternative products which can be used to help you and your family maintain and achieve better health.
--Plants are the basis of nearly every medicine out there. I rely on traditional uses and experience to understand how to use them, rather than laboratory processes. In doing this, I am following a tradition that is thousands of years old. The government should not be able to take away the choice to use these traditional choices from the public.
--My business supports me and my family. Additionally, it has offered community services for all 30 years, and offered training to many apprentice herbalists.
How else can you help?
--offer services (I am looking for a web person, and possibly a graphics person)
--buy my products! Give them as gifts. Encourage others to purchase my products.
--ask your friends, family and everyone you know to support my campaign.
It has been a privilege to serve you for the past 31 years and counting, and I pray that with your help, I will be able to satisfy the FDA regulators and continue to provide these products for you and your families.
Blessed be,
Denise Joy
My name is Denise Joy, and for more than 30 years I have run Mountain Spirit Herbals. Making medicine has been my passion since learning many years ago from my grandmother, who was the 3rd in a lineage of herbalists. In the last 30 years, I have built a business on selling high quality medicinal herbal products to the public.
Now, my ability to continue to make these products is threatened. The Food and Drug Administration (FDA) has taken to surfing the internet to find small business owners like me in an effort to force us to match the standards of pharmaceutical drug companies. In essence, they put me through the harrowing process of a drop-in visit, with multiple follow-up visits, during which time they informed me that I cannot continue to do business in the same way I have been. This in spite of the fact that never once has a complaint been made about my products, nor has any been found to be tainted, or to have caused harm to anyone.
My business is a sole proprietorship. I make, package and market nearly every item in my catalog myself. I take pride in the quality of my products. The herbs which form the basis of every product are grown organically or wildcrafted by myself whenever possible; otherwise I purchase only high quality organic and wildcrafted herbs, oils and other products from respected vendors. My emphasis is on small batch processing, ensuring the best possible product.
At this point, the FDA is insisting I make major changes to my business including at a minimum relabeling, changes in marketing and advertising, and extensive documentation on every product for every batch made.
They are treating me as a drug company even though I am careful always to stress that these are traditional uses for herbs and that a certified health practictioner should be consulted before use. At this point, I have not been given a deadline by when I must comply, but I am being told that it is necessary to do this as quickly as possible, preferably within a year.
This is my livelihood as well as my passion. To create herbal medicine that helps those in need is what I do best! I truly want to continue doing this in my life, but at a cost of an expected $20,000 over the next year, I don’t know if I can without your help. Costs will include:
--lawyer fees. I have found an excellent lawyer who specializes in helping small businesses like mine work with the FDA successfully. I will need to be reclassified as a non-drug entity, among other things
--consultant fees. I am looking for a consultant who can help me ensure that I am in compliance with the FDA rules
--development and printing of procedure manuals
--graphic designers to redesign all labels
--website fees for modification of the website
--catalog rewrite and reprinting fees
--loss of business costs. I expect that I will have to significantly change some products. Others will be relabeled and marketed differently, so clients will not know what they are. Some of my best selling products have been specifically targeted by the FDA. Additionally, I may have to take down my website for a period of time in order to make changes. The website represents a major portion of my business income
Why should you help me?
--If my products have helped you or a family member, this will help ensure they will be available to you for years to come!
--If you have never used my products, then consider whether it is important to you to have high quality alternative products which can be used to help you and your family maintain and achieve better health.
--Plants are the basis of nearly every medicine out there. I rely on traditional uses and experience to understand how to use them, rather than laboratory processes. In doing this, I am following a tradition that is thousands of years old. The government should not be able to take away the choice to use these traditional choices from the public.
--My business supports me and my family. Additionally, it has offered community services for all 30 years, and offered training to many apprentice herbalists.
How else can you help?
--offer services (I am looking for a web person, and possibly a graphics person)
--buy my products! Give them as gifts. Encourage others to purchase my products.
--ask your friends, family and everyone you know to support my campaign.
It has been a privilege to serve you for the past 31 years and counting, and I pray that with your help, I will be able to satisfy the FDA regulators and continue to provide these products for you and your families.
Blessed be,
Denise Joy
Organizer
Denise Joy
Organizer
Port Townsend, WA
