NNFA Northwest Region

Understanding Third Party Literature

By Kathy Constantine

This article is a summary from a presentation sponsored by NNFA last March in Washington, D.C.

 

Do you remember how hard the industry worked to pass the Dietary Supplement Health and Education Act of 1994 (DSHEA)?  If you were working in the industry at that time, there is no way you wouldn’t.  After struggling to find our way to effective action, the industry pulled together and mounted one of the most powerful grass-roots campaigns this country has ever seen.   We won some important freedoms that are granted under DSHEA, but many in the industry are not taking full advantage of them. 

 

One of the very important rights that is spelled out in this legislation is the “Third Party Literature” Provision (Section 403B).  Many manufacturers and retailers have only a vague idea what this section of DSHEA is all about.  Very few have read the legislation and most have not even seen a summary. 

 

This article, therefore, is an attempt to remedy this situation by presenting a simple definition of third party literature and explaining the ways that it can be used in conjunction with a sale.

 

Prior to the passage of DSHEA, retailers couldn’t give out any product information.  As a matter of fact all printed information had to be kept in a separate literature section a certain number of feet away from the products.

 

So what is different about third party literature?  The most important difference is that it provides an opportunity to give consumers information about the advances in research and it can be given to a customer in conjunction with a sale.  But before you get too excited, you have to understand specifically what it is that you can give away.

 

To qualify as third party literature your handout must be a publication that meets the following criteria:

 

1)      It is not false or misleading;

2)      It doesn’t promote a particular manufacturer or brand;

3)      It is balanced (meaning that it presents the pro and con, the state of the science, and its summary says where the science stands);

4)      It is kept physically separate from the product;

5)      There are no company identification stickers or stamps applied to it;

6)      It uses official abstracts of single studies, or summarizes a group of studies.

 

If your publication meets these criteria, you may hand it to a customer in conjunction with a sale, but you still can’t talk about it.  For instance, you still can’t say, “Vitamin E may cure your heart disease.”  If it meets these standards you don’t have to keep it in a separate literature section, though as previously stated, it should not be kept right next to the product.  There is no specific ruling in the law about how far away from the product the literature should be, but it obviously needs to be far enough away that there is no direct association, or it can be called “product labeling.”

 

Third party literature is distinctly different from structure function claims and it should not be considered a back door to making such claims.  For instance, it would not be proper to use third party literature on ginkgo and Alzheimer’s as a way to say ginkgo improves memory.  Third party literature also should not be considered an opportunity to sneak in drug claims about products.

 

The question about whether literature is balanced can be very subtle.  Some questions you can ask yourself when evaluating literature for balance are:

 

   Do the statements tell the whole truth?  For instance, if the article cites positive studies, it must also discuss negative studies, if any.

   Does the publication cite both positive and negative (if any) studies? 

   Does the publication fully describe the state of the science?

   Is the article non-promotional?

   Are the studies peer-reviewed? This is not required, but is a good indication of balance.

 

When using third party literature it is advisable to apply high quality standards, just as you would when selecting products to sell.  Low quality literature makes you an easy enforcement target. 

 

When the Congress passed DSHEA they underscored the findings that:

 

1)      There is a growing need for emphasis on the dissemination of information linking nutrition to long-term good health; and

2)      Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements.

 

With these findings in mind, Congress gave labeling exemption to a “publication” if it is one of the following, and is reprinted in its entirety:

1)      An article;

2)      A chapter in a book;

3)      An official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the authors or the editors of the publication.

 

The labeling exemption, however, does not apply to a summary of a publication, other than an official abstract of a peer-reviewed scientific publication.   

 

Point of Purchase Claims

Point of purchase (POP) brand specific literature is distinctly different from third party literature and is regulated as labeling.  All POP claims must be supported by scientific evidence and do not need to be balanced. POP literature can promote a particular brand or manufacturer, but, as with third party literature, the claims cannot be false or misleading.  

 

Point of purchase claims can only be made for:

   The prevention of nutrient deficiency diseases;

   Structure & function claims (the role of or mechanism by which the nutrient supports the structure or function in the body);

   The promotion of general well-being;

   Must include the disclaimer: “This statement has not been evaluated by the FDA.  The product is not intended to diagnose, treat, cure or prevent any disease.”                                                                                   

 

Consumers Are Looking for Information.

It is clear that consumers are hungry for reliable, science-based information in order to make informed decisions and purchases.  In surveys, consumers generally cite pharmacists as the #1 source of reliable information about health and nutrition.  Cheryl Bottger, past president of the NNFA Northwest Region, encourages retailers to become information gatekeepers.  In order to do this she recommends that they do the following:

   Understand the differences between point of purchase literature and third party literature;

   Train their staffs to use third party literature in conjunction with a sale;

   Establish a resource center in the store (such as a retail kiosk with information software, books, peer-review journals and Internet access).

 

When Answering Consumer Questions

Cheryl Bottger recommends that when retailers answer customer questions they always listen carefully to the customers’ questions and, if necessary, repeat the question back to them in your own words.  She stresses that retailers should never diagnose or recommend a product based on a personal health experience.  Rather, they should help the customer by referring them to the appropriate third party literature source.

 

What Does the Third Party Literature Exemption Mean to Retailers?

The third party literature provision gives retailers a new opportunity with mainstream customers.  It offers a powerful tool that is reliable, referenced and scientific.  If you haven’t put third party literature into your staff training and implemented its use as part of your sales strategy, you should put this on your priority list.