Complying with Allergen Controls:
An Interview with FSVP Agent, Brigitte Lehat
HACCP Certification and Allergens
Q: Why is allergen control a critical component of the FDA’s food safety standards?
Allergen control is vital because allergens are a leading cause of FDA food recalls—40 to 50% of recalls are related to undeclared allergens. This makes allergen management not only a regulatory requirement but a public health priority. Failure to control allergens can result in serious health risks, including fatal reactions, especially in people with severe allergies like those to peanuts.
Q: How does allergen control fit within broader food safety systems like HACCP?
Allergen control is part of a company’s Hazard Analysis and Critical Control Points (HACCP) system. It reflects a facility’s overall commitment to food safety. Neglecting allergen control may indicate broader lapses in safety practices.
Q: How do allergen regulations apply to importers under the Foreign Supplier Verification Program (FSVP)?
Importers are held to the same allergen standards as domestic producers. However, importers face additional challenges like the risk of cross-contamination during international transportation. For example, a product could be exposed to allergens during shipping if it’s not properly sealed or if it’s stored near allergenic products.
Common Allergens
Q: What are the most common food allergens U.S. importers need to monitor?
The U.S. currently recognizes nine major allergens:
- milk.
- eggs.
- fish.
- shellfish.
- tree nuts.
- peanuts.
- wheat.
- soy.
- and sesame.
These differ slightly from international standards—some countries (like those in the EU) may include allergens like celery or mustard.
Q: Does the U.S. accept EU allergen standards for imported products?
Generally, yes. If a product meets EU allergen regulations, it’s likely to meet U.S. standards as well. However, the FDA requires documentation to verify compliance.
Allergen Verification
Q: How can importers verify that their foreign suppliers are meeting U.S. allergen labeling requirements?
Importers should request a Certificate of Analysis (COA) from an independent, certified third-party lab. These certificates are based on the analysis of a specific product sample and should not be self-issued by the supplier. Alternatively, importers can request samples to send to a certified lab themselves. However, it’s important to note that COAs are only valid for the tested sample, not the entire production batch—so trust in the supplier’s practices is key.
Q: Does FDA registration of a foreign facility mean it is approved or endorsed by the FDA?
No. FDA registration is not an endorsement or approval—it simply allows the FDA to track and respond to safety issues. Registered facilities should not advertise themselves as “FDA approved,” which is a term the FDA reserves primarily for drugs.
Q: Will the FDA inspect foreign facilities for allergen compliance?
The FDA does sometimes inspect foreign facilities, but registration alone doesn’t guarantee an inspection. Inspections are more likely in response to issues such as recalls, non-compliance, or gaps in FSVP documentation.
Noncompliance
Q: Are importers responsible if their foreign suppliers are non-compliant?
Yes. Under FSVP, importers are responsible for verifying that foreign suppliers meet U.S. food safety standards, including allergen labeling. Failure to do so can result in import detentions, recalls, or even the loss of import privileges.
Q: What should importers do if a supplier has a history of allergen-related recalls or non-compliance?
If a supplier repeatedly has allergen-related recalls, the FDA may place them on an import alert or detention list. Importers should avoid working with suppliers who are not proactive about allergen control, or who appear frequently on FDA recall or detention lists. Supplier approval questionnaires (SAQs) should include detailed questions about prior recalls and certifications.
Q: Can a supplier with a past allergen-related recall still be approved?
It depends on the context. Some companies can recover from a recall if they demonstrate corrective actions and compliance. For instance, in one case involving saffron imports from Spain, all Spanish suppliers were initially banned due to contamination. However, after government and legal intervention, compliant suppliers were removed from the list and allowed to resume exports.