Why You Need to Actively Oppose the FDA’s NDI (New Dietary Ingredient) Draft Guidance

By Dr. Jen Morganti / NEEDS Education Director

Your access to dietary supplements is at risk! The FDA is proposing changes that could significantly limit the availability of many herbs and vitamins, and potentially increase the cost associated with manufacturing, thus putting supplements out of financial reach for the average American. We need YOU to take action and help stop this unnecessary and unjust regulatory devastation. Please see the link to the petition at the bottom of this article and take 2 minutes to help make a difference!

In 1994, the FDA instituted guidelines for marketing and manufacturing dietary supplements called the Dietary Supplement Health and Education Act, otherwise known as “DSHEA”. Within DSHEA, there is a requirement that every “new” dietary ingredient brought to market after 1994 must file as a “New Dietary Ingredient” or NDI to prove their safety. Up until now, every ingredient that was already on the market prior to 1994 was grandfathered in and did not require any additional documentation to be sold in theUS.

The NDI guidelines have been quite vague ever since DSHEA was instituted, so the FDA is finally attempting to “clarify” the NDI requirements in a document now known as NDI (New Dietary Ingredient) Draft Guidance. Unfortunately, this supposed “clarification” of the NDI sounds much more like a total revision. It significantly raises the requirements to bring a new ingredient to market, and more importantly it disqualifies many of the grandfathered ingredients that are currently being sold and used by consumers. The likely results, if this is passed, is that  many dietary supplement ingredients and formulas will be pulled off the market, many small manufacturers will go out of business because they can’t meet the stringent, expensive, time consuming new requirements, and that innovation for new ingredients will virtually cease due to the excessive expense.

Required Testing

The safety testing requirements for NDIs have been raised to a level well above what was suggested originally in DSHEA. The new NDI will require the manufacturer to submit extensive information about “new” ingredients, including expensive research on safety in humans and animals. It will require toxicology studies, human studies, and other safety studies in order to allow an ingredient to be brought to market. This will apply to many ingredients that are already on the market, which have already proven to be safe by extensive human use for many years. In addition, the current list of “grandfathered” ingredients that was created by dietary supplement industry associations and referred to by manufacturers will no longer be acceptable, thus putting the burden on each manufacturer to provide evidence that their ingredients were sold and used prior to 1994, in that exact form, using exactly the same technology. These requirements will be harder for manufacturers to meet, inevitably leading to fewer new products in the marketplace.

Redundancy in NDI Documentation Process

Beyond the fact that the FDA will require manufacturers to conduct practically drug-level research studies on perfectly safe ingredients, they will also require EVERY manufacturer to provide documentation on every ingredient in every product, even if those exact ingredients have already been approved through the NDI procedure by another manufacturer. And every time an ingredient is added to a different formulation, or used in a different dosage, it will need a new NDI to prove its safety in combination with other ingredients, i.e.: different forms of minerals will each need their own NDI, and a change in the ratio of EPA to DHA in a fish oil would require an NDI. This level of documentation is redundant and wasteful of the manufacturers’ resources and the FDA resources required to review each NDI. NDIs must be submitted 75 days prior to releasing a product to the market. The 75-day wait period can be suspended indefinitely if the FDA deems the application is not adequate, thus causing additional financial stress on the manufacturer. Furthermore, it is clear that the FDA doesn’t have adequate resources to handle the expected influx of NDI applications and it is inconceivable how this process could be managed without a significant and costly increase in FDA resources.

The Potential Downfall of the Dietary Supplement Industry

In the spectrum of food regulation to pharmaceutical regulation, dietary supplements are currently viewed more like foods rather than under the category of drugs. This proposed legislation will slide dietary supplements much closer to the category of drugs. The enormous expense of this procedure will put many nutrition companies out of business, and for those that can afford the process, they will have to increase prices closer to drug prices, without the benefit of being covered by health insurance to help absorb the cost (as drugs are). If this guidance document went into effect, it is expected to significantly cripple the dietary supplement industry to the detriment of consumers who rely on supplements to maintain their health and wellbeing.

Our current call to action is to sign the petition sponsored by Citizens for Health, “calling for Congress to withhold FDA appropriations until this unaccountable agency is held accountable: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial reinterpretation of the laws governing dietary supplements.”

This link will direct you to the petition.









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