CRN, CHPA call for NDI draft guidance withdrawal

The Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) called for FDA to withdraw the New Dietary Ingredient (NDI) Draft Guidance and replace it with a new draft guidance that "reflects the statutory language and legislative intent of DSHEA (the Dietary Supplement Health and Education Act of 1994)."

In joint comments filed to the docket, CRN and CHPA said the Draft Guidance, as written redefines the NDI notification process, contradicts the spirit of DSHEA and conflicts with nearly two decades of agency practice and policy. "It would impose significant and unnecessary new burdens on the dietary supplement industry without conferring safety benefits to consumers," the trade groups said in the comments.

The Draft Guidance would essentially undo nearly two decades of agency practice and policy that began with DSHEAs passage," said CRN president and CEO Steve Mister. "CRN and others in the industry have been calling on FDA to provide clarity through this Draft Guidance, and responsible industry fully supports a reasonable guidance that provides directions for filing NDI notices within the legal framework of DSHEA. However, this guidance does not answer that call."

The comments lists five ways the groups believe the Draft Guidance undermines DSHEA:

1. Supplement-focus

CRN and CHPA said the requirement for each new supplement with an NDI to file a notification is contrary to DSHEA's language and legislative history. "Such a policy is not grounded in practical realities or science," they wrote, "And it would result in industry members submitting burdensome and duplicative notifications that waste both industry and agency resources without providing any consumer safety benefit." They recommended FDA permit ingredient manufacturers or distributors to submit NDI notification (NDINs) for new ingredients, rather than requiring supplement manufacturers to submit NDINs for each supplement with an NDI.

2. Chemical alteration

CRN and CHPA said FDA's view that a product would be considered chemically altered unless it used a limited number of processing techniques (Minor loss of volatile components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension") is too narrow. When these processes were outlined in DSHEA, CRN and CHPA argued that Congress did not mean this to be an exhaustive list, rather, Congress intended this to be a few examples. Further, they argued this policy is not grounded in science as doesn't have anything to do with safety. They ask FDA to take a "flexible, science-based approach" that allows for a case-by-case determination of chemically altered.

3. Industry burden to show non-NDI status

While the Draft Guidance places the burden of proving an ingredient is not an NDI on industry, CRN and CHPA argue DSHEA places the burden on FDA to prove an ingredient is an NDI, and thus requires an NDIN.  Therefore, the comments said industry should self-determine whether ingredients are old dietary ingredients (ODIs, on the market before the passage of DSHEA and thus not requiring an NDIN) or NDIs, and FDA should bear the burden to proof if it wishes to argue the determination.

4. Synthetic botanicals

CRN and CHPA said the Draft Guidance is not clear on whether synthetic botanicals are considered dietary ingredients, but the comments said it appears FDA takes the position that synthetic botanicals are not dietary ingredients. The organizations say FDA is proposing a ban on nature-identical synthetic botanicals in the absence of statutory authority. Further, the comments said FDA has a long history of recognizing synthetic ingredients as long as they are identical to natural ingredients, so refusing to consider synthetic botanicals is contradictory to regulatory history.

5. Food-additive safety requirements

The Draft Guidance requires the same safety standards as food additives, CRN and CHPA said, which Congress did not intend. In fact, Congress deliberately removed dietary supplements from the food additive regulatory regime in DSHEA. CRN and CHPA take issue with FDA's references to the Redbook, which was designed to assess the safety standards applicable to food additives, in the Draft Guidance. Instead, they request FDA formulate a safety standard that meets the statutory requirement applicable to NDIs, i.e., the reasonable expectation of safety.

The organizations conclude by arguing that the Draft Guidance constitutes unlawful rulemaking by guidance because FDA uses it to announce new policies that contradict existing law and agency regulatory history. "In its attempts to upset the balance of DSHEA and to impose new substantive obligations on the dietary supplement industry, FDA has far exceeded the permissible boundaries of a guidance document," according to the comments.