DSHEA Tutorial: Disease Claim in Product Name
Non-Compliant Workaround #3: implying a disease claim through the name of the product.
Summary: You can’t hide a disease claim in the name of a product. However, hiding a claim to treat a non-disease state is okay. Using those allowed structure/function terms is also compliant.
Helps maintain non-lumpy tissues
So you can’t go implying that you’re going to cure cancer with a product name such as “Tumor Shrink”. However that doesn’t mean you can’t use words like “heart” in your product’s name.
if, in the context of the labeling as a whole, the name does not imply disease treatment or prevention. The agency reiterates that it will view the name in the context of the entire labeling to determine whether a disease claim is being made.
We can also use the word “prescription” or “Rx.” in the name of a formula, but you’ll still have to be careful…
Although these terms imply that the product is a prescription drug, some prescription drugs are intended for nondisease conditions. Therefore, if nothing else in the labeling suggests a disease use, the agency will not consider the use of “prescription” or “Rx” to be an implied disease claim.
There are ways in which practitioners have labeled their Chinese herbal supplements in order to get around making a disease claim, but on further examination of the guidelines, these “implied claims” such as naming a product “Tumor Shrink” is no more legal than the explicit claim of curing cancer.
Now, there is a problem that I believe is going to eventually be addressed in regards to some of the formula names in the TCM formulary that, when translated into English do exactly what DSHEA prohibits. An example of this would be the traditional formula “Tong Xie Yao Feng” which translates to “Important Formula for Painful Diarrhea”. Now, as described on another page in this DSHEA feature at gancao.net, we can likely get away with describing something as used for “occasional diarrhea”.
I actually talked to an FDA compliance officer recently to ask about this situation. She said the following:
- The name of the formula must be translated into English.
- The name of the formula cannot be a disease claim.
So this is a bit of a problem for us that may ultimately need to be addressed by FDA guideline changes. Until then, if I were marketing Tong Xie Yao Feng, I’d just change the translation a bit to bring it into compliance. As all of us TCM folks know there isn’t a central industry-wide list of accepted translation choices. In other words, one man’s vacuity is another man’s deficiency.
So, my thinking is that we should just fudge the translation a bit and get over it. So, this:
Tong Xie Yao Feng
(Important Formula for Painful Diarrhea)
Tong Xie Ya Feng
(Important Formula for Occasional Diarrhea That In No Way Suggests Anything Dangerous)
Something along those lines, perhaps less wordy.
The FDA often uses the terms “in context” to describe how they’ll approach the issue of disease claims in labeling. For instance if it is clear that the intent is to imply a disease claim, you’ll be out of compliance, but if the translation is more a statement of fact, you may be safer. This is going to come down to the size of the type used, its positioning on the label etc.
Let’s say we want to promote the use of Guo Qi Yin. Let’s look at the difference between two ways of presenting its name:
GUO QI YIN
(Delayed Menstruation Decoction)
for occasional menstrual cycle irregularity.
DELAYED MENSTRUATION DECOCTION
(Guo Qi Yin)
for occasional menstrual cycle irregularity.
See the difference? I believe that the FDA would see that too. I wouldn’t assume that there is too much of a difference here, but if we were looking for a non-compliant claim, we’d certainly focus on the bottom example rather than the top.
There are oodles of TCM formulas in which disease claims are found in the translated names of the formula. Many of these may need to be re-translated in order to maintain DSHEA compliance. They include:
- Bai Tai Zi Sheng Wan - Protect the Fetus and Aid Life Pill
- Dan Dao Qu Hui Tang - Drive Roundworms from the Biliary Tract Decoction
- Dao Tan Tang - Guide Out Phlegm Decoction
- Ding Chuan Tang - Arrest Wheezing Decoction
- Ding Xian Wan - Arrest Seizures Pill
- Er Long Zuo Ci Wan - Pill for Deafness that is Kind to the Left [Kidney]
- Gan Lu Xiao Du Dan - Sweet Dew Special Pill to Eliminate Toxin
- Gui Pi Tang - Restore the Spleen Decoction
- Gun Tan Wan - Vaporize Phlegm Pill
- Guo Qi Yin - Delayed Menstruation Decoction
- Hua Ban Tang - Transform Blotches Decoction
- Ke Xue Fang - Coughing of Blood Formula
- Ming Mu Di Huang Wan - Improve Vision Pill with Rehmannia
- Pai Qi Yin - Discharge Gas Decoction
- Qing Dai Tang - Clear Discharge Decoction
- Qing Gu San - Cool the Bones Powder
- Qing Re Zhi Beng Tang - Clear Heat and Stop Excessive Uterine Bleeding Decoction
- Qing Zao Jiu Fei Tang - Eliminate Dryness and Rescue the Lungs Decoction
- Qu Tiao Tang - Expel Tapeworms Decoction
- Run Chang Wan - Moisten the Intestines Pill
- Sheng Mai San - Generate the Pulse Powder
- Si Ni San - Frigid Extremities Powder
- Wen Dai Tang - End Discharge Decoction
- Wu Lin San - Five Ingredient Powder for Painful Urinary Dysfunction
- Xiao Yan Jie Du Wan - Reduce Inflammation and Relieve Toxicity Pill
- Xue Fu Zhu Yu Tang - Drive Out Blood Stasis from the Blood Mansion Decoction
- Zan Yu Dan - Special Pill to Aid Fertility
- Zhi Sou Wan - Stop Coughing Powder