FDA is finally addressing requests for a definition of “Natural”

The agency has avoided the issue for years but on November 12, 2015 the FDA published a “Request for Information and Comments” on the use of the term “Natural” in the labeling of human food products (http://tinyurl.com/ngvxw9a).  Note that the general term "food" includes dietary supplements. While cosmetics and pet foods are not part of this request for comments, it is highly likely that any definition of “natural” for use in food labeling will influence the labeling of other FDA-regulated products.  

The Federal Register Notice provides a brief history of FDA’s stance on the term “natural” and lists a number of questions the agency would like respondents to the request for information and comments to answer. From the brief history: Three Federal district courts hearing cases on natural labeling for foods containing genetically engineered ingredients and a fourth with a case on natural labeling for high fructose corn syrup have made referrals or requests to FDA for a definition of natural. There have also been several citizen petitions regarding use of the term “natural” in food labeling, including one from Consumers Union that asked the agency to prohibit the use of the term “natural” in food labeling since consumer expectations of the meaning of the term differs so much from how the term is used in the marketplace.

Previously FDA regulations have only defined natural in terms of colors and flavors (21 CFR 101.22).  The agency considers any added color to be artificial even if derived from fruits, vegetables or other natural sources.  (Compare to dyeing hair with henna—even though henna is a plant extract, it still alters the hair’s natural color.) 

According to FDA, natural flavors are substances used to impart flavor that are derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.

[Note that FDA provides this definition in a backhanded way since 21 CFR 101.22 actually only defines artificial flavors as “any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.” The definition of artificial flavor also includes any lab synthesized versions of flavor molecules.  It is interesting to note that European countries allow use of the term ‘natural identical’ for lab-synthesized flavors but FDA deems them artificial.]    

The USDA Food Safety and Inspection Service (FSIS), which oversees the labeling of foods containing meat and poultry, defines a natural food as one that “contains no artificial ingredients and is only minimally processed.”  The FSIS’s Food Standards and Labeling Policy book (see link on this page: http://tinyurl.com/nqbbutn) provides details on the meaning of ‘artificial’ and minimally processed:

(1) the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and (2) the product and its ingredients are not more than minimally processed. Minimal processing may include: (a) those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or (b) those physical processes which do not fundamentally alter the raw product and/or which only separate a whole, intact food into component parts, e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices.

As a matter of policy FDA has stated that they consider natural to mean, “that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there.”  This policy comes from FDA’s 1991 proposed rule for nutrient content claims in which the agency also proposed defining fresh and natural. http://tinyurl.com/odllnwj

While the agency did define fresh (21CFR101.95) they were unable to define “natural” because, “none of the comments provided FDA with a specific direction to follow for developing a definition regarding the use of the term ‘natural.’  Clearly it is up to concerned citizens, including industry and anyone who eats to help FDA arrive at a meaningful definition of “natural”,

The recent request for comments includes a long list of questions FDA has on the topic including, whether the food preparation or manufacturing processes should be considered; whether agricultural practices should be considered and whether genetically engineered foods should be allowed to be labeled as natural. (Scroll down to see FDA’s full list of questions.)

You may submit comments on “natural” labeling by visiting http://tinyurl.com/qdqr9b9). Or if you prefer, send us your comments and we will collate them into a submission to FDA.

Please use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time.

All the best to you!
Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com

Here are the questions FDA is seeking input on as they develop a definition for natural in food labeling. (You do not have to address all of the questions in your comments.)

:

• Should we define, through rulemaking, the term ‘‘natural?’’ Why or why not?

• Should we prohibit the term ‘‘natural’’ in food labeling? Why or why not?

• If we define the term ‘‘natural,’’ what types of food should be allowed to bear the term ‘‘natural?’’

• Should only raw agricultural commodities be able to bear the term? Why or why not? Section 201(r) of the FD&C Act defines the term ‘‘raw agricultural commodity’’ as ‘‘any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.’’

• Should only single ingredient foods, e.g., bottled water or bagged spinach, be able to bear the term? Why or why not?

• If multi-ingredient foods should be able to bear the term, what type(s) of ingredients would disqualify the food from bearing the term? Please explain why such disqualification would be warranted.

• We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term ‘‘natural’’ with ‘‘organic’’ (the USDA Agricultural Marketing Service administers the National Organic Program, which enforces laws and regulations regarding certified organic foods). We are interested in data and other information about consumers’ understanding of foods labeled ‘‘natural’’ versus ‘‘organic.’’ Is the term ‘‘natural’’ on food labels perceived by consumers the same way as ‘‘organic?’’ Or is ‘‘natural’’ perceived by consumers to be ‘‘better’’ (or not as good as) ‘‘organic?’’ Please provide consumer research or other evidence to support your comment.

• If we were to revise our policy regarding the use of the term ‘‘natural’’ or engage in rulemaking to establish a regulatory definition for ‘‘natural,’’ should certain production practices used in agriculture, for example, genetic engineering, mutagenesis, hybridization, the use of pesticides, or animal husbandry practices, be a factor in defining ‘‘natural?’’ Why or why not?

• We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term ‘‘natural’’ with ‘‘healthy.’’ We have a regulation that defines the term ‘‘healthy’’ when used as an implied nutrient content claim with specific conditions related to the food’s nutrient profile that must be met in order to use the term on the label or in labeling of a food (see § 101.65(d)). We are interested in data and other information about consumers’ understanding of foods labeled ‘‘natural’’ versus ‘‘healthy.’’ Is the term ‘‘natural’’ on food labels perceived by consumers the same way as ‘‘healthy?’’ Or is ‘‘natural’’ perceived by consumers to be ‘‘better’’ (or not as good as) ‘‘healthy?’’ Do consumers view ‘‘natural’’ and ‘‘healthy’’ as synonymous terms? Please provide consumer research or other evidence to support your comment.

• Should manufacturing processes be considered in determining when a food can bear the term ‘‘natural?’’ For example, should food manufacturing processes, such as drying, salting, marinating, curing, freezing, canning, fermenting, pasteurizing, irradiating, or hydrolysis, be a factor in defining ‘‘natural?’’

• Should the term ‘‘natural’’ only apply to ‘‘unprocessed’’ foods? If so, how should ‘‘unprocessed’’ and ‘‘processed’’ be defined for purposes of bearing the claim? If the term natural should include some processing methods, what should those methods be? In making determinations related to processing, should one look at the process to make a single ingredient of a food, or does one evaluate the process done to the formulated finished food product (or both)?

• The current policy regarding use of the term ‘‘natural’’ hinges in part on the presence or absence of synthetic ingredients. For example, under the current policy synthetic forms of Vitamin D would not be used in a food claiming to be ‘‘natural,’’ whereas naturally sourced Vitamin D (e.g., from salmon or egg yolks) could be. Should the manner in which an ingredient is produced or sourced affect whether a food containing that ingredient may be labeled as ‘‘natural?’’ Please explain your reasoning.

• What can be done to ensure that consumers have a consistent and accurate understanding of the term ‘‘natural’’ in food labeling to ensure that it is not misleading?

• What are the public health benefits, if any, of defining the term ‘‘natural’’ in food labeling? Please provide supporting data and other information to support your comment.

• Should ‘‘natural’’ have some nutritional benefit associated with it? If so, what should be the benefit? What nutrients should be considered? What data are available to support the association between ‘‘natural’’ and a given nutritional benefit, and/or between ‘‘natural’’ and certain nutrients?

• How might we determine whether foods labeled ‘‘natural’’ comply with any criteria for bearing the claim?

Food Facility Registration and Biennial Registration Renewal

Hello!

If you are crunched for time during this end of year holiday season, this may be good news from FDA:

In 2003 food and dietary supplement facilities were required to register with FDA. Re-registration or renewal was only required when information about the facility changed. As part of the Food Safety and Modernization Act enacted on January 4, 2011, a new biennial renewal requirement was established and all facilities were to renew their registration by December 31, 2012.  FDA was slow to establish a system to handle the renewals and this week FDA extended the deadline to January 31, 2013 for all food and dietary supplement facilities to renew their registration. 

All foreign and domestic facilities that manufacture or hold food or dietary supplements for sale in the US market must submit the following information:

• Facility name, address, phone number, and emergency contact phone number;
• Parent company name, address, and phone number (if applicable);
• Name, address, and phone number of the owner, operator, or agent in charge;
• Email address for the contact person of the facility or, in case of a foreign facility, the U.S. Agent for the facility;
• All trade names the facility uses;
• Applicable food product categories, as listed on the registration form;
• Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent;
• Certification that the information submitted is true and accurate and that the person submitting the registration is authorized to do so; and
• Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

There is no fee for registration and it can be done online (at Food Facility Registration or using paper or CD-ROM (see Paper or CD Registration).

A helpful set of questions and answers regarding food facility registration is available at Facility Registration Q&A

All of us at FDALabels.com and Bioscience Translation & Application wish you a joyous holiday season and a great year in 2013.
If you would like to subscribe to our FDA update newsletters, please reply to this post.

Regards,
Evelyn

Recent insights from FDA Warning Letters

Once again I’d like to share information about FDA’s recent warning letters. This time several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling.

The first involves the use of the claim “0 grams trans fat”.  In a warning letter to David’s Cookies of Fairfield, NJ, FDA stated that “0 grams trans fat” is a nutrient content claim and is “not made in accordance with the applicable requirements.”  There are no authorized nutrient content claims for trans fat. Many of you will recall our recommendation that the statement, “0 grams trans fat per serving” be used since it is a statement of fact.  You may read the entire warning letter at:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224888.htm

There were two warning letters to large corporations regarding claims relating to green tea.

In their letter to Unilever regarding Lipton’ Green Tea, FDA took exception to claims made on the company website regarding links to green tea and heart health/cholesterol levels. The agency takes the position that Lipton is promoting the product as an unapproved new drug due to these claims.

(Read the letter at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224509.htm)

Both the letter to Unilever and a letter to Cadbury regarding their Green Tea Ginger Ale discuss the agency’s objection to the use of the term “antioxidant” in relation to green tea.  FDA only recognizes Vitamin C, Vitamin A, Vitamin E and Selenium as antioxidants. We typically suggest that our clients discuss the ‘antioxidant activity’ of nutrients other than A, C, E and selenium.  The Cadbury warning letter regarding their Green Tea Ginger Ale can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224571.htm) .

These recent warning letters are interesting because they warn about claims that are really quite common in the US grocery market.  In fact, these claims that are so common that when we have warned our clients about them, they frequently say, “but everybody says that!”  These letters demonstrate that the agency is perhaps catching up with the marketplace. This is most likely because the 600 to 800 new inspectors hired a few years ago have mostly completed their training.

There are many things to consider when writing FDA compliant claims.  Armed with 12 years of experience with FDA regulations, we at Bioscience Translation & Application stand ready to help you understand the many nuances to this task. Visit us at www.BioTransApp.com

Reportable Food Registry

Hello!

I received the following email from FDA today and wanted to pass it along to you.  Please let me know if you have any questions.

The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties.

A responsible party:

1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
2. Must submit initial information; followed by supplemental reports
3. Must work with the FDA authorities to follow up as needed

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued on September 8, 2009, announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.

For more information, please read the RFR Guidance at www.fda.gov/ReportableFoodRegistry.