The long-awaited FDA deeming regulations of May 2016 took the vaping industry by storm, and now the federal agency is seemingly using copycat strategies to target the dietary supplements industry. The game-changing Dietary Supplement Health and Education Act of 1994 (DSHEA) is some 22-years old, but there has always been a great deal of confusion surrounding compliance issues for retailers and manufacturers. Finally, and without any warning, the FDA released an updated Draft Guidance just last week that appears to be bad news for the supplements industry.
Unfortunately, many of the new provisions tend to favor Big Pharma, much like the FDA deeming regulations. One of the major points of contention regarding the wording of DSHEA is the included new dietary ingredient (NDI) provisions. In layman’s terms, “new dietary ingredient” is simply FDA jargon for “new dietary supplement.” And as the vaping industry is well aware, the FDA has a strong dislike for grandfather clauses that favor existing products. The new DSHEA Draft Guidance appears to be no different.
Key Highlights of the new DSHEA Draft Guidance for the supplements industry:
- New dietary supplements must submit an NDI notification to the FDA. The NDI notification process is costly and time-consuming, which is strikingly similar to the Pre-Market Tobacco Application (PMTA) process for the vaping industry.
- The FDA will then provide a list of safety studies that the manufacturer must also submit for final FDA approval at a later date.
- Some of these “safety studies” are not even required for pharmaceutical drugs.
- Another provision of the DSHEA Draft Guidance states that new safety studies many be required in the future if the target consumer demographic of the supplement changes. For example, if the NDI notification is approved for adult consumers and then teenagers all of a sudden begin buying the product, then the NDI notification process starts all over again.
- Dietary ingredients that were marketed or contained in dietary supplements before 1994 are grandfathered and do not require an NDI notification.
- This 22-year old grandfather date is also very similar to the predicate date of February 15, 2007 for the FDA deeming regulations, largely considered the initial start date of the entire vaping movement.
The newly released DSHEA Draft Guidance also discusses investigational new drugs (INDs) which only adds to the confusion of the regulations even more. INDs refer to new drugs while NDIs refer to new supplements. The remarkable parallels between the newly released DSHEA Draft Guidance and the FDA deeming regulations is uncanny. And coincidentally, they both tend to favor Big Pharma over the vaping or supplements industries. This is copycat corruption at its most devious.
(Related Article: FDA RESPONDS TO NICOPURE LABS AND R2B SMOKE-FREE LAWSUITS)