FDA Vape Regulations

FDA Vape Regulations

FDA vape regulations pose a big question for domestic and foreign manufacturers, relabelers and distributors. Vape products may not contain tobacco, instead marketing other ingredients like CBD Oil or melatonin. FDA vape regulations do not, however, focus on ingredients in classifying the product to determine what pre-market and label requirements apply. It is also important to note FDA vape regulations are changing under a new proposed rule that broadens the e-cigarette definition to include products omitting tobacco or nicotine. This extension of FDA vape regulations will make the process clearer, but more burdensome in the future.

FDA Vape Regulations – Ingredients

FDA vape regulations focus in part on ingredients. The risks, safety concerns, and warnings for traditional tobacco or nictonie e-cigarette products is well established. The inhalation of other ingredients, traditionally viewed as dietary ingredients, may not be well studied. Typically ingredients like melatonin or Vitamin C are consumed orally and absorbed through the stomach. FDA vape regulations do not address any ingredient consumed orally in this way. Neither does the definition of dietary supplement encompass the concept of inhaling dietary ingredients. By excluding vape products from the¬†dietary supplement definition a conundrum is presented. Any use of structure/function claims or the DSHEA warning (“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”) will lead to FDA enforcement action because the product is inhaled. Yet any use of a dietary ingredient in a vape product could raise safety questions that also lead to potential enforcement actions. FDA vape regulations will in-time require pre-market approval for ingredients used in vape products. Until that time careful review of ingredients is important.

FDA Vape Regulations – Label Review

As with ingredients FDA vape regulations require a careful label review prior to entering the market. It is important for vape products to avoid labeling that would lead to re-classification as a new unapproved medical device or drug. The FDA will regulate any vape product that aims to aide in smoking cessation as a medical device. It will also regulate any vape product that claims beneficial uses considered therapeutic like drugs. Drug reclassification can occur with structure/function claims, direct or indirect disease claims and ingredient listings.

It is also important to remember labeling with depictions or references to marijuana can lead to FDA enforcement. The FDA deems these products “street drug” alternatives. This can lead to the same enforcement action as with any other misbranding offense.

Finally while FDA vape regulations are in transition to the new rule there are questions about the rote elements of labeling. For example, how ingredients are listed or the need for a facility street address, are all open questions during this period of transition. Under the new rule FDA vape regulations will be much clearer on these points.

 

Please contact our Washington D.C. or Charlotte office for a complimentary consultation on your vape products.