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)

RASFF recurrent alerts notified by Italy – Mercury in fish

During 2014 the EU Rapid Alert System (RASFF – Rapid Alert System for Food and Feed) recorded a relevant number of 62 notifications – sent only from Italy – for large size fish containing heavy metals, mercury in particular.

The countries of origin of the fish are different, but with a clear predominance of Spain, closely followed by Portugal and Vietnam.

This is a useful information for food business operators which purchase fish products from these countries: in order to avoid contaminated lots and the potential sanctions from the controlling authorities, it is strongly suggested to adopt reinforced sampling and testing activities.

Swordfish, tuna and mako shark, are among the main species involved and the values ​​of mercury found by the authorities were very different from one case to another (from 0.7-0.8 mg / kg to 5.4 mg / kg and above): from this risk are exempted canned foods, usually derived from fish of medium size, less exposed to this kind of contamination. It must also be pointed out that the risk arising is not of immediate/acute type, but is more likely a cumulative toxic effect.

Following a request from the European Commission, in 2014 EFSA (European Food Safety Authority) released a Scientific Opinion to assess health benefits and risks associated with the consumption of fish and the potential presence of mercury. The Panel concluded that consumption of about 1‑2 servings of seafood per week and up to 3‑4 servings per week during pregnancy has been associated with better functional outcomes of neurodevelopment in children compared to no consumption of seafood. Such amounts have also been associated with a lower risk of coronary heart disease mortality in adults and are compatible with current intakes and recommendations in most of the European countries considered. These associations refer to seafood per se and include beneficial and adverse effects of nutrients and non-nutrients (i.e. including contaminants such as methylmercury) contained in seafood.

So, there is no need to panic, but certainly the high number of RASFF notifications is suggesting to be a bit careful in consuming too much of those species and to strengthen the official controls in this sector. Despite the presence of a real risk for human health, however, it is quite strange the total absence of news about this situation in the main newspapers, often very quick to raise excessive awareness in cases where there is not any risk (i.e. blue mozzarella).

The Italian Ministry of Health advised through its website a moderate consumption of predatory species of large size (1 serving per week of about 100 g, 2 servings for tuna), especially with regard to children and pregnant women, and pointed out that a reason for the peak of notifications to the RASFF is a consequence of the reinforced controls on the market.