Hello and welcome to this week’s Synutra Pure Blog! Today the focus of our attention is going to be on turmeric and recent rumors surrounding the supplement. The primary rumor is that turmeric has been banned by the FDA, but this is not the case. Some turmeric and curcumin products have been issued FDA warning letters or bans, but not turmeric as a whole. In today’s blog we’ll talk about how all this started getting discussed, and what it all means.
To get us started, let's talk a little about the internet and search engine results. When you Google the phrase “Turmeric FDA Ban” the first article that comes up is from medicine.net, a resource that is both written by medical professionals and reviewed by medical professionals. It is a great potential resource for people looking for information. The Google results are where things get weird. Google shows the results with the line “Is Turmeric FDA approved?” and then follows up with an excerpt from the medicine.net article on the issue. Google presents it as an answer, and the excerpt says “This supplement has been banned by the United States Food and Drug Administration (US FDA) due to its role in increasing the heart rate and blood pressure and the potential to cause cardiovascular side effects, such as heart attack and stroke.”1
That statement is pulled right from the article, yes, but has nothing to do with turmeric. The article is a well written and informative piece on the use of turmeric and other supplements while taking a cholesterol medication. In summation, it pretty much says always talk to your doctor before starting new supplements as there may be drug interaction or health concerns. What the quote is actually in reference to, having nothing to do with turmeric, is the supplement bitter orange. Bitter orange is an alleged weight loss and athletic performance product with no science to back it up. It is the substance that the above quote is in direct reference to, however, bitter orange is also not banned by the FDA, going to show that fact checking is even more vital when searching online. Ephedra, another supposed weight loss supplement, is a supplement that is actually banned due to health concerns. Bitter orange contains synephrine, a chemical similar to ephedra, and is on some watchlists and is banned by some private organizations like the NFL. Someone better versed in the internet may be able to answer why Google shows results like this, but the takeaway, no matter what, should be to always read the article and always double check.
This does not mean that all turmeric products are FDA approved. Like many supplements, there are turmeric products that have received FDA warning letters or full bans. So what is an FDA Warning Letter? There are multiple types, but the kind most common to the dietary supplement industry are General FDA Warning Letters.2 A General FDA Warning Letter is sent out to a manufacturer when the FDA finds significant violations of FDA regulations. The letter will clearly identify the violations such as problems with product claims (ie; this cures cancer! That is a false claim), problems with manufacturing processes (ie; doesn’t meet cGMP standards), or even incorrect information on usage.2 The warning letter will also include directions and a time frame for the company to to let the FDA know how they are going to fix the issue. If things aren’t fixed, enforcement action will be taken by the FDA.
If changes and fixes mandated by the warning letter are met, the FDA will do a verification of all of the necessary changes. A Warning Letter Close-Out Letter may be issued if the manufacturer has fixed everything outlined in the original warning letter and has been verified by the FDA as meeting the outlined corrective action.2 The whole thing is a fascinating process that gives manufacturers the opportunity to fix mistakes, instead of just being shut down from the get-go.
What does all of this look like in practice? A good, relatively recent, example of the process involves a product from Natures Boost LLC. On November 20th, 2020 Natures Boost LLC had a warning letter issued to them by the FDA regarding claims made about two products, Blood Boost Formula, and Turmeric Curcumin.3 For Blood Boost Formula, the company’s website made claims such as "ingredients inside the Blood Boost Formula have been studied for their effect on healthy cholesterol levels without the nasty side effects you see with statins."3 According to the Warning Letter issued, found in our references as #4 If you want to get an idea of what they look like, establish that the product is a drug instead of a supplement.
The Turmeric Curcumin product has similar issues relating to reviews and testimonials on the site that potentially recommend the product as a cure, mitigation, treatment, or preventative for a disease.4 It is also declared to be a misbranded drug without adequate directions for use.4 Since it is not a product that has been approved for any of the uses implied, there is no legal way to properly give directions for use and this is a big problem. It is impossible to write appropriate directions for use, and so it is in violation.4
This isn’t the first supplement warning letter in the world, and it won’t be the last. Turmeric as an ingredient has had its own share of problems over the years, and the FDA is investigating as issues arise. There is no blanket ban on turmeric, but some suppliers and manufacturers of the substance have been banned or issued warnings. A common concern in the industry is financially motivated adulteration of spices as a public health concern.5 The adulteration of turmeric sourced from India and Bangladesh is a growing concern. You may have noticed that turmeric is a bright yellow powder when you buy it as a spice. Well, so is lead chromate.5 At the time the research paper was written, 13 large turmeric brands including both spices and supplements had been recalled voluntarily due to excessive lead levels being found in the products. The FDAs response, to reduce and prevent future issues, was to announce an import alert that allowed detainment in ports on turmeric shipments being brought in from certain locations in India and Bangladesh.5
One of the concerns regarding turmeric is that the roots are being treated with lead chromate during the boiling and polishing process in an effort to make the product appear high quality and hide pest or spot damage and attract big buyers. At the time of the research paper’s writing, the FDA had no maximum allowable lead levels information for spices, so the researchers used the .1 parts per million (ppm) maximum allowable levels for candy products. 32 turmeric samples were purchased and tested, with 16 samples exceeding the .1 ppm of lead chromate content were found. Two samples exceeded the maximum levels by over a magnitude of 2.5
What this all means is that when looking for a dietary supplement, due diligence is important. Talk to your doctor before starting any supplements, and if you have further concerns do your own research. FDA Warning Letters are publically available, so a quick Google search of “Brand Name X FDA Warning Letter” can be a quick way to check something out. As we discussed earlier though, reading the article is vital to making sure you get all the information you can out of it. Just reading a headline may lead to incomplete conclusions.
What all of this boils down to is that the rumors are partially incorrect. There are turmeric products, both spices and supplements, that have been recalled by the FDA and the manufacturer’s that own them. They have been pulled from the shelves and the FDA is maintaining a close watch on turmeric over lead chromate level concerns. There is not, however, a blanket ban on turmeric. As long as the product makes no drug claims, has sufficient directions for use, meets good manufacturing practice standards, and meets a whole other variety of FDA checklist items, it is safe and marketable. So the big thing is to keep an eye out for warning letters related to products you buy, and keep an eye on them regularly once you have chosen a brand.
We hope that you found this week’s blog to be informative! With some of the rumors going around, even our team had to take a step back and take a look at the issue. We had heard nothing from the FDA in regards to our turmeric product, our Synthritis formulation, so we did a deep dive into the issue and found some of the problems relating to the rumors. It just highlights how important it is to double check information found on the internet. It's interesting what can spread from a poorly set up search engine result! We hope to see you again next week for our next blog!
As always, this information is not intended to diagnose or treat any illness or disease. No information in any of our blogs should ever be used as a substitute for medical advice from your doctor or another qualified medical professional.
References
1) “Can You Take Turmeric if You Take Blood Pressure Medication” May 27th, 2021
Shaziya Allarakha, MD
MedecineNet
https://www.medicinenet.com/can_you_take_turmeric_if_you_take_blood_pressure_m/article.htm
2) “About Warning and Close Out Letters”
U.S Food and Drug Administration
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters
3) “FDA Warns Seller of Curcumin and Cholesterol Supplements” Dec, 11th. 2020
ConsumerLab
https://www.consumerlab.com/recalls/14506/fda-warns-seller-of-curcumin-and-cholesterol-supplements/#:~:text=On%20November%2020%2C%202020%2C%20the,Curcumin%20to%20be%20drug%20claims.
4) “Warning Letter Natures Boost LLC MARCS-CMS 609846” Nov. 20th. 2020
U.S Food and Drug Administration
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natures-boost-llc-609846-11202020
5) “Ground Turmeric as a Source of Lead Exposure in the United States” 2017
Cowell, W., Ireland, T., Vorhees, D., & Heiger-Bernays, W.
Public health reports (Washington, D.C. : 1974), 132(3), 289–293.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415259/
