DSHEA Labeling Requirements

For many private practitioners of TCM, the sales of dietary supplements makes up an important tool for the health of our patients as well as the financial health of our practice. However there are federal regulations that describe what we can and cannot say on our labels.

When we prepare to bring our labels up to code or accordance with DSHEA requirements, we must first understand that labeling doesn't just apply to the words and graphics affixed to the bottle or container of the actual product. Any words that are printed on papers inserted with the product are also regulated as labels. In fact any publication, advertisement, or even website that provides a purchase opportunity to your product are all regulated as labeling.

For this reason, bringing your labeling up to code requires that one assess two separate areas of the business. The product's label, and all the words wherever they may appear that support that product. The law actually talks about publications available at the site of purchase. In the case of a website, this would include the webpage to which a purchase opportunity is linked.

Bottle Labels

When it comes to the labeling of your supplements' bottles the most current thinking from the FDA on this topic is found in a "guideline" document for "small entities" which are small businesses. Here's the URL:
http://www.cfsan.fda.gov/~dms/dslg-toc.htm

A quick list of what each label needs to include:

Finally, if there is a structure-function claim made, a disclaimer must be added. (i.e. "Supports the healthy function of the large intestine") Then the disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

This guideline document goes into very clear detail as to how large or small the type can be, where it must be placed and what it must say. Please note that if you're grossing less than $500,000/year in sales, you're exempt from the "supplement facts panel" on the side of the bottle or box.

So, what's okay to say and what isn't? This is quite interesting. You can talk about any herb or formula as treating anything you want. Presumably, it will be a well-referenced article or at least favor traditional uses of the formula/herb that is backed up by text books, peer-reviewed journals, etc. This is not a problem, however the moment you include a "buy now" button on a webpage or some other means by which a purchase can be made that favors one brand, manufacturer, distributor, then you've got labeling.

Notice how Margaret Naeser's article on laser acupuncture at gancao.net went to such lengths to list ALL of the outlets where the discussed laser devices could be purchased. If you list them all (or none, or a link to a google search that is random) you're not favoring any outlet and thus avoiding any claims that would be considered labeling.

So, this topic of website labeling now becomes one of "claims". There are a few different types of "claims" that can be found on labels and/or supporting documents of Chinese herbal supplements:

Health claim (aka disease claim): this is a statement that a particular supplement will have a direct effect on a disease. What's a disease? Anything that needs to be fixed is a disease. One page at the FDA site says that if it appears in a medical text, it's a disease. Does that means that Spleen Qi deficiency is a disease? It certainly doesn't appear in too many Western medicine texts. I believe that the answer will end up being "yes". The litmus test of "health claim" is if there's a problem that is being fixed. So, if your materials say that Shen Ling Bai Zhu San treats, cures, mitigates, or otherwise improves a Spleen Qi deficiency, that is a health or disease claim and guess what? Only drugs can do that! Drugs, and a few vitamins and minerals that have gone through rigorous scientific examination. Examples of dietary supplement health claims that can be made include "calcium for osteoporosis" and such. Since this law was passed in 1994, there have only been less than 15 approved health claims!

Now these health claims do not require explicit claims to be made. There are plenty of opportunities for implied claims such as the name of the product. If I wanted to make the formula name "Shen Ling Bai Zhu San" easier for a consumer to remember, I might chose a name like "diarrhea begone" in which case I am making an implied health claim.

Structure-Function claim: There are a few other classes of claims, but the one that we have to pay attention to under DSHEA is the so-called "structure-function" claim. This is where we get in to those "promotes healthy bowel movements" type statements. We can't fix diarrhea, but we can promote healthy bowel movements. Say it loud, say it proud, we can promote healthy bowel movements! But don't forget to say it to the FDA too, before 30 days have passed.

They want to know what structure-function claims are being made. You don't have to prove your claims are true, but they do require that you can maintain some sort of proof on file just in case the subject should come up at a later date. Specifically the "substantiation" that needs to be kept on file is that your claims are truthful and not misleading.

There are a few exceptions to these strict structure-function claims. Health concerns we pass through as part of life such as menopause would not be considered a disease, nor would hot flashes, night sweats, or any of the other symptoms of a normal change of life. Funny thing is, the way that the FDA limits this is by stating that if the symptom that arises occurs in a minority of the population, then it isn't considered part of a life change, but is a disease. So, if 49% of the (menopausal) population get headaches, that is a disease that we cannot claim to treat. However if 51% of the population gets menopausal headaches, it is no longer a minority and thus no longer a disease claim!

Non-Disease States: Another exception is the treatment of something that isn't necessarily related to a specific disease. The guidelines talk about a dietary supplement that "improves absent mindedness" [sic]. Because this could be considered a symptom of Alzheimer's disease, this would be an implied disease claim. However because absent mindedness is also a benign symptom of aging, the rule defaults to the ambiguity and so this statement is allowed.

A third exception deals with transitory non-disease states that are not considered a problem but more of a nuisance. An example of this would be water-weight gain during menstruation, or intermittent insomnia.

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 claims of curing cancer.

You can't market a product as "herbal antibiotic" either because the only possible use of an antibiotic is to treat infection. In this case, again we're treating a pathology and hence making a disease claim. However an herbal diuretic that could be applied to "temporary water-weight gain during menstruation" may be permissible.

A product cannot claim to augment a therapy or drug intended to treat disease. An herbal supplement marketed to treat hypertension along side beta-blockers is still making a disease claim that it will lower high blood pressure.

A product that is marketed to mitigate the side effects of drugs that are treating disease is still fixing a problem. We can't fix problems, dietary supplements can only "support normal function". So, marketing Shen Ling Bai Zhu San as a way to mop up any gastrointestinal side effects of antibiotic therapy is prohibited.

For more on structure/function claims guidelines for the small business, please see:
http://www.cfsan.fda.gov/~dms/sclmguid.html

Looking Ahead

There is currently a voluntary reporting system of adverse events for supplements and over-the-counter (OTC) drugs, however the website that is supposed to be maintaining this database has indicated that the database it built for adverse events of dietary supplements was not very workable and so the FDA's "medwatch" is not currently set up to build the necessary data needed for dietary supplements to be distinguished for their safety record. However, the Dietary Supplement and Nonprescription Drug Consumer Protection Act is a new bill in the US Senate that would replace the voluntary reporting system with a mandatory system. Under the proposed law, manufacturers, packers, or distributors of OTC drugs or dietary supplements in the United States must report to the FDA within 15 business days any reports of a serious adverse event associated with their products. Serious events include those that result in death, a life-threatening experience, inpatient hospitalization, disability or incapacity, birth defect, or medical/surgical intervention to prevent one of these outcomes.

In putting together a recent lecture on herb-drug interactions, an attempt was made to compare adverse events due to herbs and adverse events due to OTC medications. While there was no means by which one could compare the two, it quickly became evident that OTC remedies are the tool of choice among 35% of the women attempting suicide in Northern Ireland (1).

It is the opinion of the author that this bill is going to be of great value to the TCM community. Putting our products on a statistically level playing field with OTC remedies will show Americans how safe our products are compared to a class of remedies that are already trusted, namely OTC medications. The Hatch-Durbin bill, S. 3546, is as of the time of the writing of this article still being negotiated in Congress. For more, please see:
http://hatch.senate.gov/index.cfm?FuseAction=PressReleases.Detail&PressRelease_id=1598

While USA regulations remain in the Dark Ages regarding TCM herbal therapies, DSHEA has given us a place at the table to further prove the safety and efficacy of our herbal interventions. With patient respect for the law, a healthy desire to better legislate a means by which we can freely express our claims, and ongoing ethical approaches to the marketing of our remedies we can help Washington decision makers look beyond the fears of the unknown to appreciate what traditional East Asian healers have known for thousands of years.

For a more detailed explanation of DSHEA and a few regulations specific to the state of California, please see:
http://gancao.net/labeling/supplements.shtml

Al Stone is a licensed acupuncturist with a focus on TCM herbal medicines in his Santa Monica, CA practice. Al Stone can be contacted through www.gancao.net.

References:
1. Prevalence of Over-the-Counter Drug-related Overdoses at Accident and Emergency Departments in Northern Ireland - a Retrospective Evaluation
M. Wazaify et al. Journal of Clinical Pharmacy & Therapeutics
Volume 30 Page 39  - February 2005