Help Me Comply with FDA regulations
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.
At this point, we have completed the documentation systems and they are in use. We have made significant progress with relabeling, including renaming all products that were problematic, developing new labels and relabeling bottles on the shelves. There are only a few products left with old labels which we will sell out of before switching to new labels. We continue to work with customers to help them figure new names for familiar products.
The largest component left to complete is the website. Work is ongoing shifting all the language to a version which will not trigger FDA concerns. We hope to have this done in the next few months.
It's been a six month haul, and I'm feeling the effects of working straight through. Usually January and February are slow months--downtime for me. This year, they continued at a breakneck pace of 8-12 hours per day, leaving me somewhat tired going into the craft fair season. However, it's a good tired knowing that I will be able to continue to produce these products that you and your family depend on with the same very high standards.
I've spent nearly all the funding on the expected expenses listed in the early updates--label redesign and printing, web site revisions, developing manuals and documentation systems and lawyer fees. There are still some FDA related expenses that continue to stretch our resources and we could still use funds so please do share this request. We will let you know when we received a closing letter from the FDA signifying that this process is truly complete.
I could not have done this without your support. Thank you from the bottom of my heart. I am truly humbled by the outpouring of kindness and financial support that allow me to continue serving the community.
It's been a busy few weeks since last we posted here. We've got language for changing the label template, and sent it to the designer.
Some wonderful people have stepped forward. Some of the offers we haven't been able to take peole up on so far, but two have proven very helpful. One was from a couple who used to be FDA agents. They were able to answer a number of pressing questions, and have agreed to help again. We also had an FDA food lawyer step forward and offer his help pro bono, as well as that of an extern to do appropriate research, draft claims and help determine all the components that need to be completed. We'll be working with the extern in earnest next year, but in the meantime the lawyer has been very helpful and has saved us some significant funds.
The FDA has communicated with us. Essentially, they acknowledged the work that had been done, pointed out a few other things they wanted to see like registration as a dietary supplement company, and--this is the big one--made it clear that there would be no exceptions due how small a business we are. The FDA's idea of a "small business" is one with fewer than 500 employees!!! Wow. They then made a suggestion for a petition or ombudsman intervention. This we are consulting with both lawyers on to determine the best course of action.
We are very close to the goal of $20,000 and extremely grateful for your support, financially, emotionally and in sharing this request. Please continue to share it! We'd like to make it to $20,000 as the funds are going fast to pay for lawyer and designer fees. Your help is much appreciated.
Last week we had an amazing benefit with huge turn out. The community support and love was overwhelming. It was a great time with wonderful performances and a lot of time for people to talk and be in community. Thank you to everyone who came and made it a success, and a special thank you to all the performers.
Progress-wise: we have a plan for the new labels which are in process. We have partially updated the website so the oils and salves are now renamed, etc. The tinctures are next--expect to see a lot of name changes here as well. We are also in the process of rewriting our recipes into different formats and various forms which are required. All this takes time, energy and money which would not be possible without your generous support.
We spent nearly $3000 for the lawyer in October, something we were only able to do as a result of this support. Other qualified consultants have now offered help so we hope to focus the other funds on critical web updates, new labels, and other required changes.
Thank you so much for your continued support! We are very close to making the goal. Please continue to share this! Have a very happy thanksgiving.
Artis the "Spoon Man"
Henge and Friends
Live Music and FUN SURPRISES!!!!
Bring your friends and family!
I am so sorry to hear so much has to be changed (and likely the very information that made your cataloged such treasure, so i will be holding onto my last one for always! I'm so glad that the herbal community, customers, an friends have rallied around you with support to resist so grandly the forces that would limit our healing wisdom and plant allies Love and blessings, Judith
May be able to help, please look at my site: http://www.VitaminConsultancy.com -- I've worked with natural product companies for over forty years.