If DMAA is Banned, Will Your Brand
Be Ready?

by Christine Hronec

Recently, the FDA has issued warning letters to several dietary supplement companies for marketing pre-workout products including 1,3-dimethylamylamine more commonly referred to as DMAA [1]. The Food and Drug Administration challenged the marketing of these products due to insufficient safety studies and long term data to fully evaluate the long term risks of this ingredient.

This organic compound was originally patented in 1944 by pharmaceutical company Eli Lilly as a nasal decongestant [2]. It wasn’t until many years later that its benefit as a natural stimulant to the central nervous system was realized. By 2006, a company by the name of Proviant Technologies introduced this ingredient to the sports nutrition market under trademarked name Geranamine®[3].

The functional benefits of this ingredient were captured in an array of new products containing Geranamine ® after ephedrine was banned in 2005. The last 6-7 years revealed hundreds of new products with DMAA as the main ingredient such as pre-workout supplements, weight loss products, and a variety of energizing supplements. The main question to be answered now is, “what’s next?” The likelihood of consumers purchasing the same commercial products known to be tried and true sans DMAA is slim. Sports Nutrition companies are turning back to researchers to seek guidance for the best combination of ingredients that doesn’t raise any red flags with the FDA while delivering an effective product that satisfies the market demand. As of 2012, the market is simply waiting for an invention, however until that occurs, several companies are evaluating the following options:

  • Re-launching dietary supplement formulations without DMAA. This appears to be the most straightforward approach, where the primary thing that is needed is a new product label. However consumers may not be as likely to continue purchasing the product with concerns of reduced effectiveness.
  • Increasing dosages of the remaining actives in their existing pre-workout formulations without DMAA. Slight reformulations may be necessary to prove to the consumers that the product they are consuming is safe while still effective. This may prove to be slightly more complicated as product pricing may change and a new product label will be needed. This approach would be most effectively managed by launching a new product altogether.
  • Identifying alternative stimulants or like ingredients (i.e. synephrine, diethylamine, fucoxanthin). Starting from scratch may actually be the easiest approach; however it may be more time consuming than other options. This will involve product efficacy testing, however the end result of substantiated data will definitely be worth the wait.
  • Private-Label a proven formulation from a contract manufacturing company. There are several companies that offer this service enabling sports nutrition marketers to do what they do best- MARKET! Just be sure to hire your own regulatory attorney to perform the final label review to ensure that the formulation does not have any red flags before commercializing a new product.

While the verdict is still out as to when DMAA will be effectively removed from the market place, there are still many effective ingredients that are safe to use while delivering real results. The key to success at this stage in the game will go to the companies that have done their homework, conducted efficacy studies, and can back their findings with substantiated data to proving to all that safety truly is always first.

[3] http://www.baseballprospectus.com/article.php?articleid=11761

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