DSHEA Tutorial: Website Labeling


Summary: free speech allows one to make any statement about the actions of an herbal formula that are accurate and truthful. However, when those statements are associated with an adjacent purchase opportunity such as a “buy now” button on a web page, the statement becomes a “claim”.

There are plenty of places where you can make claims that need to comply with DSHEA standards.

The first is kind of obvious, that’s the bottle’s label or the packaging in which the herbs are found.

Next we have any papers, advertisements, coupons, or other materials packaged with your supplement that you sell, mail, provide, or otherwise get to the consumer. All of these things are considered “labeling”, but it doesn’t stop there.

If you have a website on which you describe your formula or product AND that page has a “buy now” button or any equivalent, that too is considered labeling.

If you have a web page that describes your formula’s action and you’re making claims but there is no “buy now” button, you’re still not out of the woods. If you link to a website where this product is for sale, then your words have become a sales pitch and again become “labeling”.

Here is a quote from an FDA statement on the matter defining their take on what actually constitutes a label:

all labels and other written, printed or graphic matter upon any article… or accompanying such article.

In addition to a 1948 Supreme Court decision, the extension of the concept of labeling applies to the following:

brochures, booklets, … motion picture films, film strips, … sound recordings, … and similar pieces of printed, audio, or visual matter descriptive of a drug… which are disseminated by or on behalf of its manufacturer, packer, or distributor…

There are a few exceptions to this, and herein lies another sort of loophole. If you have a page extolling the virtues of Shen Ling Bai Zhu San and there is no means by which you can purchase the formula from that page, then it isn’t considered labeling. That is just educational information. You don’t even have to provide the disclaimer about “These statements have not been evaluated by the FDA…” However if there is no link to a purchase opportunity, well that just sucks all the economic fun out of it.

Here’s another option. If you have a page that talks about Shen Ling Bai Zhu San and provide links to places where you can buy it, as long as no one website, manufacturer or distributor is favored, then you’re still okay to make claims and not consider your page as labeling. A good example of this is found in an article here at gancao.net that describes locations where one can purchase laser acupuncture lasers. You’ll notice that the author does not favor any one distributor, but lists them all. In a perfect world, that list would randomly put one of the outlets on the top of the list and kind of rotate through the others each time the page is viewed. However it is clear in the article that no one resource is being favored, hence that page does not need to conform to that particular FDA requirement. Of course a laser isn’t a dietary supplement, but it is a “investigational medical device” regulated by the FDA and so there are some similar regulations at play.

So, if you want to have a page that talks about Shen Ling Bai Zhu San, include links to a bunch of outlets, favoring none in particular. If these links include coding for affiliate programs whereby you can get a commission, you’re probably crossing some line there, as you have an economic interest in the purchase and this is going to count as labeling according to DSHEA.

So what is labeling? Everything that is used in support of a sale of your product. That’s labeling and its all regulated by DSHEA.

Next: non-compliant workarounds.

Last modified: August 17, 2009  Tags: ,  В·  Posted in: Claims