Is there a regulation or order related to food that you would like the U.S. Food and Drug Administration (FDA) to issue, amend or revoke? Or is there another form of administrative action you think FDA should take or refrain from taking? Recently, FDA has issued several new or revised regulations and guidance documents which impact the food industry, such as revisions to food labeling (nutrition and supplement facts panels) (21 CFR 101.108(c)), current good manufacturing practices (21 CFR 117), and the Substances Generally Recognized as Safe Final Rule.1 Perhaps you would like to express your thoughts on these or other regulations or orders to FDA in the form of a citizen petition. The following is an overview of the basics and purpose of filing a citizen petition to help offer a better understanding of citizen petitions and their potential utility in the food industry.
Purpose of a Citizen Petition If an “interested person” would like the Commissioner to “…issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action” then the “interested person” may file a citizen petition in order to initiate administrative proceedings (21 CFR 10.25). For stakeholders in the food industry, the utility of a citizen petition may arise for any number of reasons, such as a request for stricter regulations surrounding the safety evaluation of substances or good manufacturing practices, new or revised nutrition facts or warning label requirements, or product recalls. For instance, a citizen petition was recently filed to request that the Commissioner of FDA take action against a product allegedly containing synthetic astaxanthin.2,3 Another example of a recently filed citizen petition, as reported in NutraIngredients.com, requests the Commissioner to exempt dietary supplement manufacturers from “100 percent identity testing,” if manufacturing products using the dietary ingredient OptiMSM®..4,5,6
Preparing & Filing a Citizen Petition Any “interested person” may prepare and file a citizen petition, even if they are not a U.S. citizen. The “interested person” may seek the assistance of attorneys or scientific experts to compile the necessary information required in a petition. If the person so chooses, “an attorney or other authorized representative” may prepare the petition on behalf of the “interested person” (21 CFR 10.20).
A trade association may also file a citizen petition to represent its members. The filing of a petition by a trade association would not prevent members from taking “individual action of a similar type, in the member’s own name” (21 CFR 10.105). For instance, the citizen petition regarding the exemption from certain identity testing requirements for a dietary ingredient was filed by the Natural Products Association (NPA) on behalf of Bergstrom Nutrition.4,5,6
Information Required for a Citizen Petition The petition must follow a certain format, in order for the Division of Dockets Management to file the petition. The required format is as follows (21 CFR 10.30):
A. Action Requested: In this section, it must be stated what action is being requested of the Commissioner. The petition may request that the Commissioner issue, amend, or revoke a regulation or an order or to take or refrain from taking any other form of administrative action.
B. Statement of Grounds: Information related to the “factual and legal grounds on which the petitioner relies, including all relevant information and views on which the petitioners relies” is to be included in this section. Even information that is “unfavorable to the petitioner’s position” is to be included. It is important that the petitioner explain why the Commissioner is being requested to take action and state specific reasons to support such action.
C. Environmental Impact: Either a claim for categorical exclusion (21 CFR 25.30; 21 CFR 25.31; 21 CFR 25.32; 21 CFR 25.33; 21 CFR 25.34) or an environment impact assessment (21 CFR 25.40) is required.
D. Economic Impact: This information is only required if requested by the Commissioner after review of the petition.
E. Certification: The following statement (and a signature and contract information from the petitioner) must be included in this section: “The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition” (21 CFR 10.30).
FDA Response to Citizen Petitions Provided that all required information is included in the citizen petition, it is filed by the Division of Dockets Management, and the petition is open for public comment. The FDA Commissioner is to make a ruling on the petition, “…taking into consideration (i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute” (21 CFR 10.30(e)(1)). The Commissioner is to issue a response to the petition within 180 days of the filing of the petition (21 CFR 10.30(e)(2)).
If the petitioner wishes to supplement, amend or withdraw the petition, they may do so at any time before the Commissioner issues a ruling, “…unless the petition has been referred for a hearing…” (21 CFR 10.30(g)). Once a ruling has been made, the petitioner needs permission from the Commissioner to supplement, amend, or withdraw the petition (21 CFR 10.30(g)).
There are four possible responses by the FDA Commissioner to the petition: 1) Approve the petition 2) Deny the petition 3) Dismiss the petition, and 4) Tentative response (including an explanation as to why a decision could not be reached) (21 CFR 10.30(e)(2)). If the ruling is to approve the petition, FDA must simultaneously take action to begin the implementation of the request and approved action. Once a ruling has been made, the petitioner will be notified and the decision will be saved in the public docket file. If the petitioner or an “interested person” is not satisfied with the ruling, a petition for reconsideration may be filed (21 CFR 10.33).
Although the commissioner is to issue a response within 180 days of the filing of the petition (21 CFR 10.30(e)(2)), it may take much longer, possibly even years, to receive a final response from the U.S. FDA.7 The final response may not always be favorable either, as the majority of citizen petitions are denied.7,8 Even so, citizen petitions provide the opportunity for persons to express their thoughts and concerns related to FDA regulations and orders.
Now that you know the basics surrounding the preparation and filing of a citizen petition, is there a request for action you would like to include in a citizen petition? If so, please contact Burdock Group and we would be happy to help you prepare and file a citizen petition.
References:
81 FR 54959. Substances Generally Recognized as Safe. Site last accessed Jan. 4, 2018.
FDA-2017-P-6631-0001. Citizen Petition From Amin Talati Upadhye LLP [Natural Algae Astaxanthin Association (“NAXA”)]. Regulations.gov. Site last accessed Jan. 2, 2018.
NAXA Attacks Cardax’s Synthetic Astaxanthin via Citizen’s Petition. NUTRAingredients-usa.com, Nov. 29, 2017. Site last accessed Jan. 3, 2018.
FDA-2017-P-6967-0001. Citizen Petition From Bergstrom Nutrition. Regulations.gov. Site last accessed Jan. 2, 2018.
NPA Files Petition for Approval fo Skip Lot ID Testing. NUTRAingredients-use.com. Site last accessed Jan. 3, 2018.
NPA Seeks New Process for Validation of Nutritional Supplements, First-Ever Request of Its Kind Submitted on Behalf of Bergstrom Nutrition. NPA.org. Site last accessed Jan. 4, 2018.
Chen, B.K.; Yang, Y.T.; Cheng, X; Bian, J.; Bennett, C.L. (2016) Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis. Plos One, 11(5).
Carrier, M.A.; Wander D. (2013) Citizen Petitions: An Empirical Study. Cardozo Law Review, 34.