What Are The Compliance/Enforcement Considerations For Gluten-Free Products
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The Gluten-Free Rule allows food free of gluten by nature to bear a gluten-free labeling claim provided it meets all FDA requirements for a gluten-free food. The rule also allow manufacturers to place the voluntary gluten-free claim anywhere on the food label as long as it does not interfere with the mandatory labeling information.
Compliance/Enforcement Considerations for FDA
Any food product bearing a gluten-free claim must meet the rule’s requirement or be subject to FDA’s enforcement. For FDA-regulated foods that have an outdated gluten-free claim on the label, the length of time given to such product to be cycled off grocery store shelves will vary depending on inventory, product shelf-life, consumer popularity of the product and other variables. FDA ensures compliance by using its routine post marketing monitoring activities such as: Sampling, periodic inspections of manufacturing facilities, conducting food label reviews, follow-up on consumer and industry complaints, conducting gluten analyses of food samples.
Compliance/enforcement considerations for manufacturers and suppliers
The pathways to accomplish compliance are as follows: Product testing to determine the gluten level but testing alone is not sufficient to ensure gluten compliance. Other measures are: Investing in quality management system that evaluates suppliers assurance, Good manufacturing practices (GMPs) and ongoing training.
Compliance/Enforcement Considerations for Retailers and Specifiers
Retailers must have confidence in their sources of gluten-free products by implementing a structured supplier qualification program. This includes verification through supplier certification or internal verification testing, applying in-store, separation and hygiene rules.
Supplier Compliance Regulations
Treat supplier compliance as an extension of your own business process. Suppliers could be third-party organizations but they are also extension of your enterprise. Therefore enforce compliance standard, policies and activities in your supply chain with same level of diligence and commitment that is applied within your organization. To create a truly compliant and risk aware supply chain, you choose the right suppliers based on a third-party risk assessment. Know who you are doing business with, beyond just your tier 1 suppliers. Learn who your suppliers’ suppliers are. Try to learn their corporate and compliance objectives and only choose those whose objectives align with yours.
Supplier Assurance Evaluation
In order to creditably support gluten claims companies must have: Control for gluten in the supply chain at every step. Suppliers must be able to deliver, produce and document a consistently gluten-free ingredient, which involves having appropriate procedures for communicating any changes in their ingredients that may affect gluten status, assessment of processes and sub-ingredients, assessing suppliers’ certification, assessing suppliers’ internal monitoring program, and pre-shipment verification testing.
Good Manufacturing Practices (GMPs)
The suppliers’ program should be supported with GMPs that prevents cross-contamination and co-mingles gluten-free ingredients with others. This includes separation and segregation, managing and limiting people and equipment traffic across the site, dedicated and easily distinguishable equipment, appropriately validated cleaning regimes, sufficient space around equipment and between production lines to ensure cleaning is effective and to facilitate adequate inspection and maintenance, and prevention and/or mitigation of the potential for airborne impacts.
If a manufacturer uses a gluten-free claim on its packaging, but do not meet the requirements of the FDA, the product could be deemed misbranded. The regulatory actions of FDA against misbranded products include: Monetary penalties, no-sale orders, product seizures or injunctions. All companies looking to export requires to be aware of other region’s requirements for gluten-free claims. In general, the 20ppm requirement of the FDA rule is consistent with international standards including Codex Alimentarius Commission’s revised Codex Standards for Foods for Special Dietary Use of Persons Intolerant to Gluten. European Commission Regulation No 41/2009 that concerns the composition and labeling of foodstuffs suitable for people intolerant to gluten. Codex Standard, European Commission Regulation. Australia New Zealand Food Standards Code and Health Canada included oat as gluten- containing grains whereas the US final rule does not.