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Will the Anticipated NDI Guidance Hint at IP Protection?

That’s not the only question Dr. Corey Hilmas, NPA’s senior vice president, scientific and regulatory affairs, has.

In the 20-plus years since the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the federal government has not provided additional protections to dietary supplement firms that file pre-market safety notifications with the Food and Drug Administration (FDA).

What incentive do firms have to file New Dietary Ingredient (NDI) notifications, especially considering there is no federally granted market exclusivity for dietary supplement firms?

Filing NDI notifications to the FDA and conducting clinical trials represent a significant investment of capital, time, and resources for any manufacturer and distributor. Unfortunately, dietary supplement firms will never recover those investments by way of market exclusivity, which occurs in the pharmaceutical industry, granted by the FDA. Instead, dietary supplement firms must rely on patents and trade secrets to protect their growth portfolio.

DSHEA requires a manufacturer or distributor of a NDI to submit a scientific dossier to the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) on the chemical identity, history of use, or other evidence of safety under the proposed conditions of use of the dietary ingredient contained in the dietary supplement.

The NDI notification, akin to the approval process for drugs, must be submitted for dietary ingredients that are new and have never been on the market prior to October 15, 1994 within 75 days of going to market.

While firms that submit a premarket notification are taking the appropriate steps to ensure consumer safety prior to going to market, are they actually just hurting themselves in the end?

While NDIs are not required when a dietary ingredient was on the market before October 15, 1994 or when an ingredient is deemed to be identical to one that has already been introduced to the market through the NDI process, some folks rely on previously submitted notifications from competitor firms as the basis of their assurance for reasonable expectation of safety to the FDA.

In short, the copycat firm never files a notification when its competitor has paid the price for notifying the agency with an NDI. This is certainly a strong reason not to file. The issue is that the FDA can enforce simply on the basis of a failure to file an NDI. Typically, the agency likes to have a reason such as a safety concern in order to call the product adulterated under 402(f)(1)(B), but theoretically it could use the charge in the future if it finds a lack of safety data in the public domain.

Dietary supplement firms are also being forced to conduct randomized, double-blind, placebo-controlled clinical trials (RCTs) to substantiate their claims in the same manner as drug companies. The Federal Trade Commission (FTC) is trying to force dietary supplement companies to substantiate structure/function claims according to the drug standard for competent and reliable, which equates to performing two RCTs. In the absence of market exclusivity rights how does a firm recoup its return on investment for the NDI notification and clinical trial substantiation? While drug companies are subject to the two RCT rule for substantiation of drug claims, pharmaceutical intellectual property (IP) enjoys far greater protection.

Protection of IP, invested by dietary supplement firms, has not been addressed by the FDA. The agency is unaware as to whether an ingredient is derived from an identical ingredient supplier as indicated in the competitor’s NDI notification, is sourced the same way as the notifying firm, or is processed in the same manner.

IP protection starts with elimination of that practice by the FDA. A firm’s reliance on borrowed science not actually performed on its own ingredient or product is not something the FDA should tolerate. Patenting ingredients, paying the freight for NDI safety studies and claim substantiation efficacy studies, and preparing the NDI notification are all costs incurred by firms to protect their IP from theft. Defending the patent alone is a costly venture where the cost of defending the patent can be greater than the total sum for products at risk to IP theft.

The FDA fails to discourage the practice at present. Will the agency address the issue in the much anticipated NDI Guidance? The Natural Products Association hopes industry media outlets will continue to provide a platform to increase awareness of IP infringement occurring in the marketplace, which impacts product quality, safety, and efficacy. When the manufacturing process is not identical and therefore the product not the same, IP infringement should not be permitted by the FDA on any level.

How can anyone take NDI submission seriously if FDA does not take IP protection seriously?

TAGS: Regulatory
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