FDA Warning Letter – “Healthy” products

This is an interesting example of warning letter issued by the FDA. It gives not only some indications about the use of the term “healthy”, but examines also other profiles of non compliance about allergens (“Contains…”).
“The Food and Drug Administration (FDA) reviewed the label for your Dark Chocolate PlumSweets product in July 2014. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 343) and regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s home page athttp://www.fda.gov.
 
Your Dark Chocolate PlumSweets product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim.
 
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the labeling of a food product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
 
Specifically, the label of your Dark Chocolate PlumSweets product bears an implied nutrient content claim, because it bears statements suggesting that the product may be useful in maintaining healthy dietary practices and those statements are made in connection with claims or statements about nutrients. Specifically, the label of your Dark Chocolate PlumSweets product bears the claim “deliciously sweet and healthy diced plums…” in connection with the statements “Indulge in the Ultimate Antioxidant treat…” and “Dried Plum Whole Fruit Antioxidants + Decadent Dark Chocolate Goodness = The Ultimate Antioxidant Snack.” In the context of this label, FDA considers the claim “deliciously sweet and healthy diced plums…” to be an implied claim about the food itself. However, this product does not meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2).
 
In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) (i.e., the food has a saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of the calories are from saturated fat).
 
According to the Nutrition Facts panel, your product contains 5 g of saturated fat per 40 g serving of the food. This amount exceeds the maximum of 1 g of saturated fat per RACC for the food and the maximum of 15% of calories from saturated fat in the “low saturated fat” definition. Accordingly, your product does not meet the requirements for use of the nutrient content claim “healthy” on a food label [21 CFR 101.65(d)(2)]. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products or their labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. You should take prompt action to correct the violations. Failure to promptly correct the violations may result in regulatory action without further notice, including seizure and/or injunction. 
 
In addition, in accordance with section 403(w) of the Act, when a food manufacturer opts to use the word “Contains” followed by the name of the food source from which the major food allergen is derived, this information must be placed immediately after or adjacent to the list of ingredients. The “Contains” statement on your product label is placed at the bottom of the information panel after various printed information such as how to store the product and other non-mandatory labeling information.
 
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction”.
(Source: FDA Website)

GFSI paper on mitigation of food frauds effects

In July 2014 GFSI released a paper on mitigation of food frauds.

Inscatech applauds the Global Food Safety Initiative (“GFSI”) in their decision to include new requirements specific to food fraud mitigation in the next full revision of the GFSI Guidance Document (7th Edition) to be released in 2016. Details can be found in GFSI’s position paper, “GFSI Position on Mitigating the Public Health Risk of Food Fraud”, released on July 14, 2014.

Inscatech was a key member of the GFSI Board Sponsored Food Fraud Think Tank which was convened to further advance the Food Fraud mitigation topic, and was instrumental having its recommendations adopted by the GFSI Board of Directors. Its fellow Food Fraud Think Tank members included Eurofins, who brought perspectives on analytical testing and certification, and Michigan State University’s Food Fraud Initiative, an interdisciplinary, education and outreach organization. The manufacturers and retailers perspectives on the Think Tank were represented by Danone, Walmart and Royal Ahold respectively. Inscatech congratulates its colleagues on the Food Fraud Think Tank for collaboratively achieving this groundbreaking advancement in Food Fraud prevention.

The new GFSI requirements specify that companies perform Food Fraud vulnerability assessments and implement a Food Fraud vulnerability control plan to mitigate identified vulnerabilities (“The Think Tank recommends that two fundamental steps are taken by the food industry to aid in the mitigation of Food Fraud: firstly, to carry out a “food fraud vulnerability assessment” in which information is collected at the appropriate points along the supply chain (including raw materials, ingredients, [finished] products, packaging) and evaluated to identify and prioritize significant vulnerabilities for food fraud”, “Secondly, ‘appropriate control measures shall be put in place to reduce the risks’ from these vulnerabilities. These control measures can include monitoring strategy, a testing strategy, origin verification, specification management, supplier audits, and anti-counterfeit technologies. A clearly documented control plan outlines when, where and how to mitigate fraudulent activities.”)

GFSI formally defined a broad definition of Food Fraud to include adulteration, but also all fraud – explicitly including misbranding and stolen good (“Food Fraud, including the subcategory of economically motivated adulteration, is of growing concern.  It is deception of consumers using food products, ingredients and packaging for economic gain and includes substitution, unapproved enhancements, misbranding, counterfeiting, stolen goods or others”) and it could be linked to public health issues (“The GFSI Board recognizes that the driver of a food fraud incident might be economic gain, but if a public health threat arises from the effects of an adulterated product, this will lead to a food safety incident.”)

Inscatech is the first and only company currently providing Food Fraud vulnerability assessments and control plans. Inscatech is a Food Fraud detection and prevention company. The only company of its kind, Inscatech has established a solid reputation in the food industry as both a pioneer and the sole provider of food fraud intelligence investigations, forensically based vulnerability assessments, supplier qualification examinations, validated supply chain mapping, and food fraud vulnerability control programs. Through its work with many of the largest food producers and retail grocery conglomerates globally, Inscatech is leading the food industry towards a harmonized and systematic approach to protecting the safety and authenticity of the global food supply.

For more information, please visit: www.inscatech.com or contact me directly.