Apr 8, 2010

Posted by in Health, Supplementation | 0 Comments

Topical, Transdermal, Sublingual… INGESTION?

What are acceptable means of ingesting a dietary supplement?

Dietary supplements are governed by the Federal Food, Drug and Cosmetic Act (FD&CA). Within the FD&CA, we find the Dietary Supplement Health and Education Act (“DSHEA”), which provides specific guidelines for what constitutes a dietary supplement. As counsel to many sports nutrition companies, over the years we have seen this segment of the industry push the envelope of innovation, striving to bring new and more effective products to market. For example, esterification of vitamin supplements and modified versions of creatine have been introduced in order to make good products better by improving absorption efficiency. However, products that are developed to use transdermal, topical or sublingual delivery are a wholly different matter.

The sports supplement industry has seen a number of products introduced to the market that are intended to be sprayed or rubbed on the skin. Some of these products have been for a “topical” or localized effect on the affected area, while others are meant to have a systemic effect through absorption by the capillaries. This transdermal effect is one way the ingredients can bypass the metabolic process and more directly make their way into the bloodstream. This delivery method is commonly seen in transdermal “prohormone” products or in weight loss products touted to provide targeted fat loss. While this can be a very efficient way to accomplish the goal of getting active ingredients into the bloodstream, it is also considered by FDA to be a drug delivery method. In fact, prescription drugs such as Androgel®, which is used for testosterone replacement therapy (TRT) in men, or drugs developed for pain management often use some of the same “carriers” that you might find in the aforementioned sports nutrition products, such as ethanol (ethyl alcohol), isopropyl myristate, and Dimethyl sulfoxide (DMSO).

Another delivery method that has been inappropriately used in sports nutrition products is sublingual delivery. Using this method, the product is placed under the tongue where it dissolves, bypassing the “first pass” of oral metabolism, and diffusing the active ingredient(s) directly into the bloodstream through the tissues under the tongue. This is another delivery method that is commonly used for prescription medications such as cardiovascular drugs and barbiturates.

So where can we find the law that identifies acceptable delivery methods for sports nutrition products? The answer is found in DSHEA. As is the case with many aspects of the law which govern the dietary supplement industry, DSHEA provides for how a dietary supplement may be administered, as opposed to providing a laundry list of methods that are prohibited. Within the formal definition of a dietary supplement, DSHEA states that a dietary supplement “is intended for ingestion in pill, capsule, tablet, or liquid form.” The key word in this definition is ingestion, which means to “take in for or as if for digestion.” Digestion, by definition, cannot include transdermal, topical or sublingual delivery. This forms the basis for FDA’s position on these kinds of products, which has been, is, and likely will continue to be that they are not dietary supplements and that they therefore violate the FD&CA.

What are the potential consequences of marketing these products? In some instances FDA may send a Warning Letter to a company found to be marketing a product in violation of the FD&CA, identifying the violation and indicating a time frame for corrective action to be taken. An example of the kind of language included in a letter of this kind is, “only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements.” Companies that receive a Warning Letter are fortunate that FDA chose to invoke its regulatory discretion by notifying the company of the violation and providing an opportunity for the company to address the problem. Violation of Federal regulations can result in civil and criminal penalties for the company and even the individuals responsible for the violation. Companies seeking to market sports nutrition products should consult with experienced legal counsel before they introduce a product to market in order to ensure that the product is compliant with Federal laws and regulations

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