How does the US regulate food contact materials?
Q&A with Dennis Keefe, Director of the Office of Food Additives, US FDA
Ahead of this year's Food Contact Regulations USA conference, we caught up with Dennis Keefe, Director of the Office of Food Additives, US Food and Drug Administration (FDA). He explained how the US regulates and controls substances in food contact materials, and offered some tips for companies that are required to comply with the regulations.
Dennis will be speaking on day one of the conference about the regulation of food contact materials in the US. Click here to find out more and take a look at the programme for the event.
Q: How does the US regulate and control substances in food contact materials (FCMs)?
In general, all substances used in food contact materials are regulated as food additives and are subject to premarket approval by the FDA prior to market entry. The Office of Food Additive Safety is responsible for administering the FDA’s robust premarket review programme for food ingredients, including food contact substances. The premarket approval requirement was established by the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act.
Between 1958-1997, our regulatory oversight of substances intended to come into contact with food was primarily through our food additive petition process. This resulted in many food additive regulations listed in Title 21 Code of Federal Regulations (CFR), describing the safe conditions of use for specific food contact substances.
Then, in 1997, the FDA Modernization Act established a definition and a premarket notification process for most food contact substances, effectively replacing the petition process as the primary means for authorising new uses of food contact substances. Since 1997, we have reviewed nearly 2,000 food contact substance notifications (FCNs), and the effective ones are listed in our inventory of effective FCNs.
Q: What are the US FDA's main aims in terms of controlling the use of substances in FCMs?
Our main objective is to ensure food safety by making sure the FCMs are safe under their intended conditions of use. We do this by having a robust premarket review programme for food contact substances. This allows the FDA to evaluate the safety of a substance before market entry.
During the premarket review process, FDA scientists review the scientific evidence to determine whether the information provided by the notifier meets the safety standard of “reasonable certainty of no harm” under the intended conditions of use. The agency has streamlined its FCN programme to conduct scientifically rigorous, timely reviews of complete FCNs without compromising food safety.
Q: What are the main provisions within the FDA's FCMs programme (specific to the substances used)?
Generally, the regulatory status of an FCM depends on its individual components. If any substance in the material is reasonably expected to become a component of food as a result of its intended use, even in tiny amounts, then it must be authorised for the intended use by one or more of the following:
• a food additive regulation listed in Title 21 Code of Federal Regulations (CFR);
• an effective food contact substance notification (FCN);
• a threshold of regulation (TOR) exemption;
• Generally recognised as safe (Gras) status (for example, by a Gras notice, a select committee on Gras substances (SCOGS) conclusion, a listing in 21 CFR 182 (Substances generally recognised as safe), a listing in 21 CFR 184 (Direct food substances affirmed as Gras)), or a listing in 21 CFR 186 (Indirect food substances affirmed as Gras); and,
• a prior sanction letter, issued by FDA or the US Department of Agriculture prior to September 6, 1958, or a listing in 21 CFR 181 (Prior-sanctioned food ingredients).
If a substance is not already authorised for its intended use by one or more of these mechanisms, then it requires premarket authorisation.
Additional information is available on our web page on Determining the Regulatory Status of Components of a Food Contact Material.
Q: How are these regulations/provisions enforced?
As provided for by the Federal Food, Drug, and Cosmetic Act, the FDA has several tools by which it protects consumers from adulterated food. These include inspection, voluntary destruction, sampling, recall, seizure, injunction, and criminal prosecution. You can read more about FDA’s compliance and enforcement activities on our website.
Q: What tips can you give companies that are required to comply with the regulations (ie the FDA's FCN programme)?
We recommend companies review our web page on Determining the regulatory status of components of a food contact material to better understand our regulatory framework. If a company is considering submitting an FCN, we recommend they review our chemistry, toxicology, environmental, and administrative guidance to better understand the information contained in a complete FCN. If, after reviewing our website, or in the course of preparing a regulatory submission there are questions, they may be sent through this portal on the FDA’s website. We are here to help.
Q: What are the biggest challenges the FDA faces in implementing and managing this work?
To achieve our mission to protect and enhance consumer health by ensuring the safety of substances added to food and FCMs, our biggest challenge is to administer a premarket approval programme that integrates the best available science within the constraints of our statutory authority in a manner that enables the development of safe, innovative products without compromising food safety.
Q: Where do you see the US FCM programme going in the next two to three years? Are there any next steps or plans, in relation to controlling and regulating FCM substances, on the horizon that companies should be aware of?
The agency will continue optimising our premarket review processes for food contact substances in support of innovation in the FCM area without compromising food safety. We are exploring more targeted approaches for monitoring emerging scientific information about the safety of FCMs. We are always seeking to improve our programme and welcome stakeholder input.
Q: Why are you looking forward to attending Food Contact Regulations USA?
We are looking forward to attending Food Contact Regulations USA and engaging with stakeholders by sharing views on our respective roles and responsibilities for ensuring the safety of FCMs.