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FDA Issues Draft Guidance Relevant to Use of Nanotechnology in Food and Food Packaging

The FDA recently issued a draft Guidance titled, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives.” Although broader in scope, this draft Guidance covers the use of nanotechnology in the manufacture of food ingredients, including color additives and food contact substances, e.g., packaging. Similar to the message of a simultaneously issued draft Guidance on the use of nanotechnology in cosmetics, the message of this draft Guidance is that food or packaging manufacturers who incorporate nanoscale ingredients into their products should be prepared to prove that the resulting products are safe and that appropriate tests were used to validate their safety.

The draft Guidance includes a review of the statutory and regulatory provisions governing food, food additives, and food contact substances. Food is considered adulterated if it includes a poisonous or deleterious substance or an unsafe food or color additive. In this context, “unsafe” means “not pre-approved by FDA” unless the additive is generally recognized as safe (“GRAS”) by experts in the field. In general, color additives must also be pre-approved and there is no GRAS exception for color additives. FDA’s approval of food products assumes that they are manufactured according to good manufacturing practices (“GMP”).

The draft Guidance then describes FDA’s process for assessing the safety of a food substance. In connection with the manufacturing process, the draft Guidance notes that the manufacturing process can affect the identity of the food, the conditions of its use, and the level of impurities it contains. The draft Guidance then states:

As with any other manufacturing technologies applied to food, nanotechnology and other emerging technologies may introduce issues that warrant additional or different evaluation during a safety assessment of a food substance. For example, so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts (Ref. 13). . . . When a food substance is manufactured to include a particle size distribution shifted more fully into the nanometer range, safety assessments should be based on data relevant to the nanometer version of the food substance. Where nano-engineered food substances have new properties, additional or different testing methods may be necessary to determine the safety of the food substance...Thus, as with any studies to support the safety of food substances, studies to establish the safety of food substances manufactured using nanotechnology should have been appropriately validated for these materials.

For food or color additives that have been approved by regulation, foods that have been identified as GRAS, or food contact substances that have been approved via a food contact notification to FDA, when there is a significant change to the manufacturing process, including the incorporation of nanoscale ingredients, the draft Guidance recommends that the manufacturer take several steps:

  • Determine what changes have been made to the food substance, including its physicochemical structure and properties, purity and impurities
  • Conduct a safety assessment for the food substance, including the factors set forth above, bioavailability, and toxicity
  • Consider whether the substance is within a relevant regulation, GRAS determination, or food contact notification
  • Consult with FDA about your conclusions 
  • Make a regulatory submission if warranted

The draft Guidance states the FDA’s view that it is unlikely that nanotechnology applications in food substances will qualify as GRAS, so formal premarket review and approval will be necessary.

In short, manufacturers of foods, food or color additives, and food contact substances who plan to incorporate nanoscale materials into their products will have to consider conducting safety testing of their products, according to tests that are validated for use with nanoscale materials, and obtain the FDA’s approval prior to marketing the products, or risk FDA enforcement action.

As always, it is important to recall that FDA Guidance documents do not have the force of law, but rather simply represent the FDA’s current thinking on a topic. 

© 2020 BARNES & THORNBURG LLPNational Law Review, Volume II, Number 123


About this Author

Philip J. Faccenda, Jr., Barnes Thornburg Law Firm, South Bend, Corporate and Finance Law Attorney

Philip J. Faccenda, Jr. is the Managing Partner in the South Bend, Indiana office of Barnes & Thornburg LLP. He concentrates his practice in the areas of municipal finance, corporate transactions, and state and local taxation.

Mr. Faccenda regularly counsels and assists clients in financing transactions and general corporate matters, and he also assists clients in the acquisition and disposition of businesses. Mr. Faccenda serves as bond counsel in a variety of taxable and tax-exempt financings, including transactions for local government capital projects, non-profit facilities...

Glenn Killoren, Barnes Thornburg Law Firm, Elkhart, Corporate and Real Estate Law Attorney

Glenn E. Killoren is a partner in Barnes & Thornburg LLP’s South Bend and Elkhart, Indiana offices, where he is a member of the firm’s Corporate Department and co-chairman of the firm's Nanotechnology Group.

Mr. Killoren concentrates his practice on general corporate matters including mergers and acquisitions, corporate finance, succession and tax planning, among other areas. He also has experience counseling clients on estate planning and commercial real estate matters, as well as considerable experience working in the recreational vehicle industry. He counsels RV manufacturers on a variety of issues including dealer financing, intellectual property, regulatory compliance, warranty claims and product liability. He was selected for inclusion in The Best Lawyers in America® 2011 in the field of corporate governance and compliance law.

In his work with the nanotechnology industry, Mr. Killoren is active in the University of Notre Dame’s Innovation Park (technology commercialization), Irish Angels (venture capital) and the Nano-Business Alliance.

Lynn C. Tyler FDA Compliance Attorney Barnes & Thornburg

Lynn Tyler helps innovative companies secure and preserve their market position and competitive advantage. He advises on FDA compliance, helps protect clients with patent infringement and validity opinions, helps and enforce intellectual property rights — which often must be asserted against imitators who seek to reap where they have not sown.

An accomplished advocate, Lynn litigates and represents clients involved in virtually all stages of the dispute resolution process, including pre-litigation counseling, alternative dispute resolution, formal and informal...

Todd Vare IP lawyer Barnes Thornburg

Todd G. Vare is a partner resident in the Indianapolis office of Barnes & Thornburg LLP. Mr. Vare represents clients in the protection and enforcement of intellectual property rights in trial and appellate courts around the country, and was listed in the 2012 edition of Best Lawyers in America.

Mr. Vare has litigated patent disputes covering a wide variety of technologies, including herbicides/pesticides, dielectric fluids, genetics, pharmaceuticals, medical devices, telecommunications, microprocessor and integrated circuit designs, software programs...