2013: The Year FDA Got Serious

As the dietary supplement industry approaches 2014, we might characterize 2013 as the year FDA got serious about regulating this marketplaceand thats a good thing in my book. Here are my top five regulatory hot issues:

GMP Inspections: Full steam ahead

In 2013, we saw FDA seriously ramp up GMP inspections of dietary supplement facilities under Part 111. Its been a harsh lesson for some, and a learning experience for others, but its clear that companies that want to avoid the embarrassment of a warning letter, and potentially seizures or prosecution, need to be familiar with the nuances of the regulations and fully comply with these requirements. FDA has demonstrated its muscle by calling out companies that dont know a batch record from a master manufacturing record, and responsible firms are applauding the crackdown. Ultimately, that means better quality products for our consumersand we want more of this in 2014.

Putting a Label on Caffeine

We started 2013 with a flurry of media reports on the dangers of too much caffeine in too many products, from energy shots and drinks, to chewing gum and even waffles. Dietary supplements, as well as conventional foods, got wrapped up in the controversy. At CRN, we took a proactive approach and developed recommended guidelines for the industry on labeling the total amount of caffeine in its products. Since our board adopted the program in March, other supplement associations have followed suit. Now consumers can make informed decisions about the amount of caffeine they are ingesting from their supplements, which is more than you can say for most coffeehouse drinks.

Waiting for a Beverage Guidance

Related to the caffeine situation, FDA has promised a final guidance in early 2014 that addresses the distinction between dietary supplements and beverages. This distinction is more than just the decision whether to put a Nutrition Facts or Supplement Facts box on your label. That determination (food or supplement) should help marketers determine what ingredients they can use and how they market their products to consumers. FDA, were waiting...

More Waiting for the NDI Guidance

Speaking of waiting, 2014 should be the year we get a revised draft guidance on new dietary ingredients (NDIs). This past year, the industry completed a series of productive discussions with FDA where we presented our concerns about the previous draft and had thoughtful conversations with the agency on how to balance the statutory requirements for NDIs that appear in DSHEA and the agencys safety concerns, on the one hand, with the need to promote innovation and new product development in the industry. Im optimistic that FDA listened to our concerns and our recommendations for balancing these tensions in a way that serves everyones interests. Stay tuned for the outcome.

FDA has Badges and Guns

For companies that have wondered whether noncompliance has consequences, the FDAs actions on dimethylamylamine (DMAA), dendrobium and ageline should send the message that when public safety is at stake, the agency is learning to use all the hammers it has in its toolbox. We saw seizures, recalls, and destruction of products all used to address the agencys concerns for safety regarding these ingredients. This year has truly shown that FDA has started to appreciate and to use the enforcement capabilities it has when consumer health is involved.

As I look into my regulatory crystal ball, we should expect an active FDA in 2014 as well. Federal budget issues will continue to limit FDA resources, but this year has illustrated that FDA has the ability to regulate the industry under the authority it already has.