When the FDA sits on a standards committee

A lot of what looks official was written outside the government

Many of the specifications a product page appeals to were not written by a regulator. They come from professional bodies, trade associations and international organizations.

Agency staff often sit in the rooms where those specifications are drafted. A single regulation governs how, and it is more informative than its title suggests.

It defines the territory broadly. Standard-setting activities include "the development of performance characteristics, testing methodology, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling", and other technical or policy criteria.

And the posture is positive rather than grudging. "FDA encourages employee participation in outside standard-setting activities that are in the public interest."

What the section then does is attach conditions, and those conditions are what a reader can use.

Three kinds of outside body, handled differently

The section separates standard-setting by other federal agencies, by state and local governments and international organizations, and by private groups.

The first two run on a similar model. An employee may take part after the activity is approved under internal procedures, and approval forms with background information go into a public file on standard-setting activities.

For the state, local and international category, the availability of records is governed by the ordinary public records rules.

Both carry the same fairness provision about who gets invited. A member of the public may be invited to present views to, or accompany, the employee at a meeting. Where that happens, "the invitations will be extended to a representative sampling of the public", named as consumer groups, industry associations, professional societies and academic institutions.

And in both, a liaison representative has to refer all requests for information or participation to the organization running the activity, not answer them personally.

The private-body route needs a letter, and the letter says three things

Private groups and organizations are handled with more paperwork, and this is the category most compendial and trade standards fall into.

The organization has to request official participation in writing, describe the scope of the activity, and demonstrate that minimum standards are met.

If granted, a letter goes from the Commissioner or a center director to the organization, and it must state three things.

The first is "Whether participation by the individual will be as a voting or nonvoting liaison representative".

The second is the sentence a reader of product marketing should keep. The letter must state "That participation by the individual does not connote FDA agreement with, or endorsement of, any decisions reached".

The third is a recusal. The letter must state "That participation by the individual precludes service as the deciding official on the standard involved if it should later come before FDA."

The regulation then defines the term so the recusal is not arguable. "The deciding official is the person who signs a document ruling upon the standard."

The three minimum standards an outside activity has to meet

Participation in a private standard-setting activity is conditioned on the activity itself satisfying three requirements.

The first is about method. The activity "will be based upon consideration of sound scientific and technological information, will permit revision on the basis of new information". It is also designed to protect the public against unsafe, ineffective or deceptive products or practices.

The second is about motive, and it is unusually direct. The activity and resulting standards "will not be designed for the economic benefit of any company, group, or organization", and will not be used for price fixing or hindering competition. They also "will not involve establishment of certification or specific approval of individual products or services."

That last clause is worth pausing on. A standard covered by this section is not a product approval mechanism, and an activity that certified individual products would fall outside it.

The third is about access. The responsible organization must have a procedure giving an interested person "an opportunity to provide information and views on the activity and standards involved, without the payment of fees", and those views must be considered.

How that happens, in person or in writing, is left to the organization. But the no-fee condition means a paywall around participation is not compatible with the section.

Membership is not participation

One paragraph draws a line that gets blurred in promotional writing.

"Membership of an FDA employee in an organization that also conducts a standard-setting activity does not invoke the provisions of this section unless the employee participates in the standard-setting activity."

So an agency employee belonging to a body is not, by itself, the agency taking part in that body's standards work.

The reverse is also true: participation in the activity is covered whatever the membership position is.

For a reader, the practical version is that a claim about agency involvement should be traceable to an activity, not to a roster.

The exemptions, and the list of named associations

Two exemptions exist and both are documented rather than informal.

The Commissioner may determine in writing that direct involvement in a particular activity is in the public interest and promotes the objectives of the law and the agency. That determination can exempt the participation from the endorsement disclaimer, the recusal condition, or both.

That determination goes into the public file on standard-setting activities and the relevant administrative file. The regulation gives examples of what such an activity may include: establishing and validating analytical methods for regulatory use, drafting uniform laws and regulations, and developing public health and preventive medicine recommendations.

The second exemption is a list. Because of close daily cooperation and the number of employees involved, participation in the activities of eighteen named associations of state and local government officials is exempt from the private-body procedures.

That exemption is not total. A list of the committees and other groups of those associations still goes into the public file.

The named associations are food, feed, milk, shellfish, radiation control, environmental health, public health and pharmacy bodies, among them the national association of boards of pharmacy.

The neighboring section: which documents have force

A companion section sorts the agency's own output, and one sentence in it is easy to miss.

On regulations: "Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both."

So the fact that something sits in the Code of Federal Regulations does not settle whether it is a requirement. Some codified provisions are recommendations wearing the same clothes.

On recommendations: beyond guidance documents, the agency issues recommendations on matters its statutes authorize but that do not involve direct regulatory action, model state and local ordinances among them.

Those may be handled under the guidance procedures, but kept in a separate public file and separated from guidance documents in the published notice, or published as regulations instead.

On agreements the rule is strict, and it is the sentence worth remembering. Formal agreements and memoranda of understanding go into a public file on agreements, and "A document not included in the public file is deemed to be rescinded and has no force or effect whatever."

How to use this when reading a product claim

The most useful line is the endorsement disclaimer. Where a standard was set by an outside body with agency participation, the participation letter itself has to say that taking part is not agreement or endorsement.

So a claim that a standard is government-backed because officials helped write it runs directly against the condition on which they helped.

The second useful line is the certification limit. An activity within this section does not establish certification or specific approval of individual products, which means meeting a standard is not the same as a product being approved.

The third is the fee condition. Any interested person can put views into a covered activity without paying, which makes these processes more open than they look from outside.

One limit on this article. Only these two sections of part 10 were read in full. The internal staff manual procedures the section relies on, the guidance document section, and the public file itself were not examined.

And the standards texts themselves are not described here. They are separately published and separately copyrighted, and nothing from any of them is quoted here.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 10.95, Participation in outside standard-setting activities, read in full for the definition of the activities, the three categories of body, the required contents of a participation letter, the three minimum standards, the membership provision and both exemptions — Electronic Code of Federal Regulations, Office of the Federal Register, November 2014
2. Title 21 Code of Federal Regulations section 10.90, Food and Drug Administration regulations, recommendations, and agreements, read in full for the requirement-or-recommendation distinction, the handling of recommendations and the public file rule for agreements — Electronic Code of Federal Regulations, Office of the Federal Register, November 2014