Compliance With EU Food Regulation: What if Traceability and Food Recall are Not Enough?

Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy

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EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to food firms wish to comply with EU directives and/or individual European country food laws as well as for European firms intending to export food products for human and animal consumption into the US marketplace. Almater/LEXMA are independent consultants under contract to EAS. Their combined resources are now available through EAS Consulting Group. The White Paper, titled “Compliance with EU Food Regulation: What if Traceability and Food Recall Are Not Enough?” discusses the extent to which the EU regulatory framework on food may impact and challenge the traditional operations of food manufacturers, particularly once a crisis erupts as well as how integration of legal, regulatory and technical expertise may improve the efficacy of a food manufacturer’s crisis management plan. Case studies are included as illustrations of how traditional operational methods resulted in aggressive responses by either EU or individual European country authorities Together EAS,

The White Paper, titled “Compliance with EU Food Regulation: What if Traceability and Food Recall Are Not Enough?” discusses the extent to which the EU regulatory framework on food may impact and challenge the traditional operations of food manufacturers, particularly once a crisis erupts as well as how integration of legal, regulatory and technical expertise may improve the efficacy of a food manufacturer’s crisis management plan. Case studies are included as illustrations of how traditional operational methods resulted in aggressive responses by either EU or individual European country authoritiesTogether EAS,

Together EAS, Almater, and LEXMA provide highly technical regulatory consulting assistance with expertise in both European and US food safety laws, regulations and their enforcement by the respective government authorities. The use if this expertise will better enable firms to meet the new and changing European and American requirements for food processors, particularly those that are “foreign suppliers” from a US perspective and are required to comply with FDA’s Food Safety Modernization Act (FSMA). EAS provides technical assistance to US-based food processors and importers in becoming compliant with the FSMA Preventive Controls and FSVP while Almater and LEXMA provide assistance from the perspective of a European food processor intending to keep its US market open and available.

Understanding the Drug-Cosmetic Conundrum When Marketing Your Products

Products marketed as cosmetics can easily find themselves the target of FDA compliance action based on improper claims and statements.

FDA is charged with enforcing the laws and regulations that ensure the safety and labeling of products, including cosmetics, that account for 20 – 25 % of all U.S. consumer spending.

Cosmetics were first regulated under the 1938 Federal Food, Drug and Cosmetic Act (FFDCA). They are defined as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles…”.

By comparison, drugs are defined as articles (1) intended to treat or prevent disease or (2) that affect the structure or function of the body. Cosmetics are products that provide mostly superficial effects that do not include “nutrition” as with foods or that “treat or prevent disease or affect the structure or function of the body” as with drugs. Because of the narrow definition and generally low safety risk for cosmetics, they can be marketed, with the exception of color additives, without pre-approval by FDA.

As with all products regulated by FDA, cosmetics must be safe and properly labeled. A cosmetic is considered unsafe (adulterated) if (among other things) “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual…”. Also, cosmetics must be labeled in accordance with the applicable laws which include the FFDCA and the Fair Packaging and Labeling Act (FPLA).

Under this regulatory framework, a product can be classified as both a drug and a cosmetic. Product classification depends on the intended use which is determined based on claims made for marketing the product and whether or not the statements fit the definition for cosmetics and/or drugs. Because of the difference in the regulatory schemes for cosmetics and drugs, FDA has sought over the years to make sure that a marketed product stays within the established boundaries that apply. For example, a cosmetic may not make claims that the product will treat and prevent a disease or alter the structure or function of the body.

So how does one tell what claims pose a risk that a product will be classified as a drug and subject to FDA compliance action? This is a complicated question and there are no quick, easy answers. Product classification does not necessarily depend on the presence of a single word or phrase and FDA will typically make a determination based on all product statements and representations or “claims” taken together. FDA’s Warning Letters provide the most readily available source of information on claims.

Let’s look at what types of claims are problematic based on recent warning letters. Many problem claims relate to a structure or function of the body (skin) which is appropriate for a drug rather than a cosmetic.

A warning letter dated October 18, 2016, based on an establishment inspection and a website review, noted:

  • The product label said, “It stimulates cell-cell interaction, assists in the formation of collagen, and increases skin elasticity…”
  • The website included the claims “Stimulates cell-cell interactions, and accelerates cell renewal” and “Helps to preserve cellular energy, assists the formulation of collagen and strengthens in structural proteins”
  • The product insert included the claims “[I]nduces signal transduction…reconstructs protein structure…acts as a topical Botox…”, “[S]timulates cell respiration and increases cell turnover.”, “[A] biosafe alternative to Botox, it relaxes muscle contraction…” and “Increase Microcirculation”.

A warning letter dated September 20, 2016, based on a website review, cited the following claims:

  • “Lemon, a powerhouse of vitamin C…with its antibacterial properties, and boosts collagen production…It also lightens age spots…”
  • “By increasing blood flow…”
  • “Organic shea butter is a powerhouse… has natural anti-inflammatory properties that can take the sting out of insect bites.”

A warning letter dated April 14, 2016, based on a website review, noted:

  • The product website included the claim – “Removes Wrinkles Instantly”
  • Product Ingredient Claims – “Tests using a 0.5% concentration of the culture have shown a clear reduction of uneven pigmentation and obvious lightening if the skin.”
  • “A super anti-oxidant …eliminates age spots, contains protection from ultraviolet A and B and boosts collagen synthesis.”

As you can see from these examples, products marketed as cosmetics can attract FDA compliance action based on improper claims and statements. The FDA issued more than 29 warning letters to cosmetic firms in 2016.

EAS labeling experts are available to assist with the regulatory compliance of claims for cosmetic products.

FDA Urges Industry Groups to Develop FSMA Guidance

The Food and Drug Administration is encouraging industry groups and trade associations to develop their own guidance to help their members comply with new requirements under the Food Safety Modernization Act.

FDA laid out steps for developing guidance in a January 31 constituent update and said the agency would help by providing technical advice and by checking for any potential conflicts with federal regulations.

FDA would prefer the scope of the industry guidance be kept broad to increase its usefulness for any future FDA guidance. The agency is especially interested in guidance on topics not covered by existing or planned FDA guidances.

The recommended steps are:

  • Define the scope of the guidance – produce grown in a greenhouse, for example – and decide how much of the process will be included, whether just a single process or the entire supply chain, and whether the guidance is for regional, national or international use;
  • Establish a work group of experts from industry and academia – and invite both state and federal government;
  • Develop draft guidance;
  • Finalize the document and circulate it to stakeholders for comment – including state and federal regulators.

The agency said it may place links to final industry guidance on its website.

FSMA extended FDA’s authority to include produce all the way to the farm level. The agency issued a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption on November 27, 2015. That rule went into effect on January 26, 2016, with staggered enforcement dates depending mostly on size. Certain sprout growers were required to comply by January 2017 – because sprouts are considered to pose a higher food safety risk.

In January, the agency issued draft guidance for compliance of sprout operations with the produce safety rule. But there is plenty of room for additional guidance for other products.

FDA has said it will rely heavily on partnerships during the implementation phase of FSMA. Realistically, it has no other option. The call for industry-developed guidance is part of this strategy and it will certainly help both the agency to leverage its limited resources, and for industry groups to share best practices for safer food.