Dietary Supplement Health Education Act Tutorial
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President William Jefferson Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. [Source]
From DSHEA came a series of rules, and guidelines on how dietary supplements should design their labeling and any other publications in support of a given dietary supplement. Many TCM practitioners have begun to sell herbal products online. The vast majority of which rely on copying label conventions from each other.
Last modified: September 1, 2009 · 
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Tags: Claims, DSHEA, Labeling · Posted in: DSHEA
DSHEA Tutorial: Designing Your Label
Introduction to designing a label consistent with Dietary Supplement labeling guidelines.
The DSHEA Statement of Identity is essentially the name of the product. For our purposes, we’re going to use Shen Ling Bai Zhu San (Ginseng, Poria, Atractylodes Powder). This is a formula for diarrhea due to Spleen qi deficiency if we just want to give it to our patients. For the general public, we’ll have to water that claim down a bit. More on that when we’re talking about claims.
Last modified: August 31, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Statement of Identity
The DSHEA approved label Statement of Identity is the name of the product. Should it be in Chinese characters? Pinyin? English? Morse code?
The DSHEA Statement of Identity is essentially the name of the product. For our purposes, we’re going to use Shen Ling Bai Zhu San (Ginseng, Poria, Atractylodes Powder). This is a formula for diarrhea due to Spleen qi deficiency if we just want to give it to our patients. For the general public, we’ll have to water that claim down a bit. More on that when we’re talking about claims.
Last modified: August 30, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Dietary vs. Herbal Supplement
You can label your product “herbal supplement” if you prefer that over “dietary supplement”.
Next we need to identify this product as a dietary supplement as part of the statement of identity.
According to the FDA guidelines on this topic, you can actually delete the word “dietary” and replace it with an appropriately descriptive term such as “herbal supplement” though I favor “Chinese herbal supplement”.
Last modified: August 29, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Net Quantity of Contents
This article describes the best way to display the quantity of the contents of your dietary supplement.
The “Net Quantity of Contents” is a statement of how much powder or how many capsules will be found inside the container.
So again we’ll want to make sure that the words are level and upright as we would view the product on a shelf like in your front office if you’re a typical TCM practitioner or Rite-Aid if you like to think big, or Target if you like to think bigger, or Wal-Mart if insanely obsessed with becoming a household name.
Last modified: August 28, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Supplement Facts
How and when you have to list your supplement facts on your dietary supplement label.
If your company is making less than $500,000 per year then you don’t have to include the “Supplement Facts” on your label. If you are making more than $500,000 annually, you’ll probably want to go ahead and spend a few bucks on legal experts in package labeling and stop trying to save money by getting this information online here at gancao.net.
Last modified: August 27, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Ingredient Listing
How does one list herbal supplement ingredients? This tutorial answers that question.
This is another rather easy part, it’s simply a list of your ingredients.
This list of ingredients is supposed to be found on the panel to the right of your primary display panel (from the perspective of the consumer looking at the label.) This panel is called the “information panel”.
Last modified: August 26, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Business Name and Address
This article describes the DSHEA requirements for one’s business name and address in regards to a dietary supplement label.
You should put that on the information panel which if you don’t remember is located to the right of the principal display panel. The direction of “right” is based on the perspective of the consumer looking at the bottle on a shelf. Now, if your ingredients have filled up that entire information panel, you can continue on to the right on the ingredient panel. Because we’re basically working with a cylinder here, if you move over to the right one more panel, you’re actually on the panel to the left of the principal display panel. Think of it like there’s only three panels. What doesn’t fit on the principle display gets moved over to the right one panel, the information panel.
Last modified: August 25, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Dosage, Directions For Use
How to label the suggested use or dosage on the label of a DSHEA complaint herbal supplement.
On some of the FDA labeling guidelines, this is required, on others it is not. However by including this information you not only help the consumer derive a successful response from the herbs, but you can also protect yourself from liability should the consumer misuse the product.
Last modified: August 24, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
DSHEA Tutorial: Label Requirements Review
Everything you need for your DSHEA compliant herbal supplement label.
Statement of Identity
Net Quantity of Contents
Nutritional Information
Ingredients
Name and Place of Business
Suggested Use
Country of Origin (if from outside US)
Expiration Date
Structure/Function Claim (optional)
Last modified: August 23, 2009 · al · No Comments
Tags: DSHEA, Labeling · Posted in: Labeling
