WASHINGTON—In a jointly issued press release, dietary supplement industry’s trade associations—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA)—called for an overhaul of FDA's Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient (NDI) Notifications and Related Issues, which the organizations say undermines both the letter of the law and the intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
“We are all committed to seeing a substantial overhaul of the draft guidance and are united in our common belief that the document is overreaching and contravenes DSHEA," the five associations announced jointly.
The trade groups said the Draft Guidance, issued by FDA in July, as written, would burden industry, placing unreasonable requirements on business, especially smaller firms, and create unreasonable barriers of entry for newer market entrants, without any related benefits for consumers.
While the groups submitted separate comments to reflect their own membership priorities, the five associations stressed FDA should focus on the common themes in their respective submissions, rather than look for points of disparity as indicating any substantive differences of opinion among the groups.
Common key issues identified in the Draft Guidance by the trade groups representing the dietary supplement industry, if implemented and enforced by FDA, include:
Supplement-focus—All trade groups 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," CRN and CHPA wrote in their jointly filed comments.
Chemical alteration—All the trade organizations also 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, the organizations argued, Congress did not mean this to be an exhaustive list, rather, Congress intended this to be a few examples.
Old dietary ingredient lists—In its comments, NPA called for the agency to recognize a consolidated list of Old Dietary Ingredients (ODIs) created by industry trade organizations. They noted ODI lists were developed by the AHPA, CRN and NPA, which were later consolidated by UNPA. While the Draft Guidance places the burden of proving an ingredient is not an NDI on industry, CRN, CHPA and APHA argued DSHEA places the burden on FDA to prove an ingredient is an NDI, and thus requires an NDI notification (NDIN).
Synthetic botanicals—Even though synthetic botanicals are not a constitute of an herb or botanical, they should still be considered a dietary ingredient, according to the trade groups. CRN and CHPA said FDA is proposing a ban on nature-identical synthetic botanicals in the absence of statutory authority. NPA argued that FDA has allowed synthetic forms of vitamins, minerals and amino acids.
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. NPA requested FDA be more flexible when it comes to showing safety data of NDIs when they have little history of use.
Multiple NDI filings for the same dietary ingredient—AHPA said it believes separate notifications are not required, per DSHEA, when the initial NDIN provides a description of a dietary supplement or a range of dietary supplements that would include the NDI. NPA pointed out FDA's seemingly contradictory views on the matter, with in-person communication with FDA staff being at odds with what is written in the Draft Guidance.
The trade associations called on FDA to consider the comments and to issue a new guidance that addresses these concerns. The associations also urged for a timely response from the agency to provide industry with clarity and direction as the industry attempts to comply with the requirements of the law, and the associations offered to work with FDA to achieve that goal.
