I start this column with a simple question: Is the natural products industry under assault by Congress and FDA? To many in the industry it certainly feels that way. There is no doubt that Congress is looking to strengthen FDA’s authority over dietary supplements by providing the agency with stronger enforcement tools, such as mandatory recall authority, and requiring that FDA give industry guidance regarding what constitutes a “new” dietary ingredient (NDI).
 
In addition to these efforts, FDA has stepped up its use of warning letters to get companies to comply with its interpretation of the Federal Food, Drug, and Cosmetic Act. In one warning letter, for example, FDA told a fruit juice company that it was using an impermissible nutrient content claim when comparing the level of sugar in its product to a competitor’s product. In another warning letter, the agency called out a popular cereal company for using what it considered an unapproved drug claim for its multigrain cereal.
 
With regard to mandatory recall authority, which will impact both food AND dietary supplements, the industry needs to make a better effort to change the language in the food safety legislation currently making its way through Congress. Aside from this, there are some good aspects to the mandatory recall provisions. In particular, it will give companies more due process protection compared to the voluntary recall system currently in place. Moreover, there are specific procedural safeguards designed to protect a company if a mandatory recall is ordered. From a legal standpoint this is a positive, but from a business standpoint those safeguards will have little value because FDA will be able to hold product it believes is adulterated and poses a serious health risk—and then issue a press release about it. Thus, once the 24/7 news cycle kicks in, it won’t matter whether a product is truly adulterated; this product will be judged to pose a serious health risk by the media and the public, essentially destroying the brand’s reputation.
 
Moving on to NDIs, in the event a company does not notify FDA of its new dietary ingredient, it is deemed adulterated and therefore subject to the proposed mandatory recall provisions. More specifically, a “new” dietary ingredient is considered adulterated as a matter of law if FDA was not notified of its introduction into interstate commerce 75-days in advance of the ingredient being marketed.
 
Let’s add another layer to this. FDA has generally taken the position that an NDI is not only specific to the submitter, but also the product formulation. In other words, under this interpretation, every time a new dietary ingredient is combined with different ingredients, a new submission is required. Otherwise, the new product formulation is considered adulterated as a matter of law from an FDA perspective and would be subject to mandatory recall if the legislation passes.
 
With that said, at a minimum, industry should insist on adding language that makes it clear that failing to file an NDI with FDA does not give the agency the right to conclude that an ingredient poses a serious risk of harm. Rather, FDA should have to demonstrate that the ingredient does in fact pose such a risk of harm. Further, the burden should be on FDA to demonstrate that the notification provisions were violated and not the marketer. Otherwise, as it stands today, many innovative ingredients could be considered an NDI if FDA takes the position that a new form or different standardized level of an old dietary ingredient is so novel that it causes the old dietary ingredient to be turned into a new dietary ingredient subject to the notifications provisions.