A Letter To Our Customers
Here at Cape Fear Naturals,
We want to explain our FDA Warning Letter to our Old and New Customers to address any confusion, concerns or questions. We would like to apologize for all the NEGATIVE postings the FDA has caused us by coming to Inspect our facility. We are still in business and the FDA currently has no issues with our products or operations. The FDA has never told us that we could not sell any of our products or that they were dangerous or unsafe. Our products are 100% true to what they are used for and they work. We have been selling our products on Amazon and our Cape Fear Naturals website for over 9 years now. We have never had any major customer complaints about our products being bad or having adverse side effects. We have reviewed any and all issues that customers may have had and worked hard with those customers to fix any problems.
The FDA routinely investigates all companies, small and large, selling Dietary Supplements to make sure that they are in compliance with the Current Good Manufacturing Practice Guidelines (cGMP) Regulations. After visiting the companies, they post the “Warning Letter” which outlines all issues found during the inspection. Without specifically referencing the cGMP and not understand the legal jargon this can cause public confusion and misunderstanding regarding the outcome of the company inspection. The FDA also posts “Close Out Letters” when all things have been resolved however these letters are not posted as frequently or as promptly which also leaves the public uninformed of the outcome of the inspection. Throughout this entire process we have never been told that we are doing incorrect business practices, selling bad products or suspended as a business from operating and selling our products.
The FDA first came by to check on Cape Fear Naturals on September 13 and September 15, 2016 to inspect our facility, our products and our paperwork. On March 2, 2017 we received our Warning Letter which outlined the issues they found so that we could address and correct these issues to maintain cGMP compliance. Basically, we were told that there were some minor labeling issues with our products, some issues with what we were and were not allowed to say regarding our product claims on our website and our amazon store and our Standard Operations Procedure Manual was considered inadequate. The FDA has been back two times since our first visit and has helped us greatly in ensuring our Standard Operations Procedure Manual complies with all guidelines.
The FDA did not find any direct issues with our actual products regarding our manufacturer, the ingredients or their product safety. All of our Supplement products are made by a pharmaceutical company in New York. Our supplement manufacturer is a reputable company that has been in business for around 30 years, meets all the requirements for cGMP guidelines and voluntarily maintains numerous certifications and registrations with the leading industry organizations to further emphasize their mission of producing the highest quality dietary supplements. All of our ingredients for our creams and deodorants come from reputable vendors and have also been reviewed and determined to be acceptable by the FDA.
In the warning letter, our supplements were said to be misbranded. This was only because of some minor labeling issues. For example, we had to add the disclaimer “**These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease” to all of our labels. We also had to add our phone number 910-319-7392 to the labels. There were other minor adjustments such as changing supplement facts panels to reflect the technical name rather than the common name and some adjustments to some of the % daily values.” All of the product labels were adjusted and submitted to the FDA for re-review. According to the FDA our labels now satisfactorily meet all the required guidelines listed in Subpart G of the cGMP.
The warning letter referenced our products as Unapproved New Drug Violations and Misbranded Drugs because of the original claims that were made regarding the products on our website and our Amazon store. The FDA does not regulate or review the effectiveness of dietary supplements but they do regulate what you can and can’t say about a dietary supplement. You cannot make claims that would imply they “diagnose, treat, cure or prevent any disease” because these claims would mean the product is classified as a drug rather than a dietary supplement. Some of our original claims, although backed by clinical studies and research, fell into what would be classified as drug claims and we were informed we could not make such statements. We removed all such claims from our website and Amazon store. The FDA allows you to make claims about dietary supplements that are classified “Structure Function Claims.” To meet FDA guidelines structure function claims the manufacturer must have substantiation that the claim is truthful and not misleading. We submitted our new structure function claims to the FDA for review and approval. The FDA approved our structure function claims and we then updated our website and our amazon store to only reference those approved structure function claims.
The largest issues the FDA had with Cape Fear Naturals was that our Standard Operations Procedure Manual (SOP) was inadequate because it did not fully cover everything that is required for written procedures and required records, (Part 4 and Part 5 of cGMP). Our originally SOP submitted before we received our warning letter was accurate but it was not elaborate enough. Since then, we have been diligently making all corrections that the FDA brought to our attention as to what is required and in our SOP and adjusting the wording of some sections to reflect the proper “legal jargon” rather than the common wording. This was not a simple task. Our Standard Operations Procedure Manual now addresses everything listed in Part 4 and Part 5 of the cGMP including but not limited to labeling, storage, the facility, record keeping, and complaints and is over 200 pages long.
We just completed our annual FDA visit on April 9, 2019, which lasted 3 days. Our facility and products were re-inspected and re-reviewed and everything went well. We still must adjust the wording of a few small sections of our SOP using some of the specific terms and language they want to see. These adjustments are very minor and will be addressed promptly. I hope this will help ease the minds of those that may speak out against Cape Fear Naturals.
Here at Cape Fear Naturals we want to remind you that we strive to have great customer relationships and customer service with everyone. If you have questions or concerns please reach out to us by phone 910-319-7392 or email us at firstname.lastname@example.org rather than posting lengthy bad reviews that can seriously affect our livelihood as a small family run business. Over the last year our Amazon sales have dropped to less than half of what they were and we were not able to figure out what had changed. We discovered an inaccurate, ranting review dated March 1, 2018 from “AMAZON CUSTOMER” that we felt that could be very misleading to our customers. This is the only negative review we have ever had for Beta Glucan. It was not even a review from a verified purchase and it never mentioned the product Beta Glucan. Beta Glucan 400mg is one of our best selling products. We have so many repeat long time customers that love our Beta Glucan 400mg. Before that, in April 2017, a blogger who is not fully informed about our company or products, posted a negative blog post regarding our company and the FDA warning letter on their personal website. This person took our FDA letter and twisted around a lot of facts to make an inaccurate portrayal of our business and what our issues were with the FDA. Things like the false reviews and uninformed, negative blog posts in today’s world can be a serious business killer and that is just not right. If these people would have just taken a moment to contact us we would have been happy to talk with them first about any of their concerns.
We want to assure all our customers once again that we only offer supplements produced by a large, reputable GMP manufacturer in the dietary supplement industry. We only sell quality products that have been reviewed for their safety by the FDA. We keep our prices very reasonable prices so that you, our customers, can afford the health supplements that you need and want. We have been in business since 2009 and hope to continue as this is something that we fully believe in and are truly passionate about.
Jack and Lyn Whitley
Owners of Cape Fear Naturals