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)

4 thoughts on “FDA Warning Letter – “Healthy” products

  1. What is interesting is that the FDA is out of date in terms of the whole “saturated fat” issue. The epidemiological studies originally used to say that saturated fat was a driver of heart disease have been debunked. In fact, the mistaken demonization of saturated fat and cholesterol that drove the “low fat,” “non-fat” sectors lead to expanded use of both transfers and added sugars, both of which were counter-productive for societal health. I’m no fan of unfounded health claims, but we would be better off without any of them than with a system that doesn’t even keep up with our state of knowledge. FDA should also be pointing out that although anti-oxidants are good things in our diet, they are not magic and eating tons of them is not automatically a good idea.

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  2. Grapedoc, you may not know but a few years back some Ph.D. enologists did not believe 19th century research and made a good start on destroying the California grape (wine) industry. They declared that American roots were not required on European grapes. Of course, Phyloxera took over all of those vineyards. Your moniker looks a little like you were one of those University of California goof balls.

    I have been one of the biggest critics of FDA on LinkedIn. However, your accusations seem to be totally without any supporting evidence. While we have known for at least 75 years that fat is determined primarily by species and then by organ. Yet it is secondly determined by environment. However, that does not prove that diet does not affect accumulation. Clearly, an absolute vegetarian can suffer from malnutrition while eating plenty of calories, but plants produce fats and oils and humans produce their own cholesterol.

    To me the noun “transfer” is something (paper) that gives you the right to pay for a ride on a public conveyance, get off and get on another public conveyance without an additional fare. They generally taste unpleasant! The links of excess sugar to both obesity and tooth decay are also on the order of 75 years old. So, what new information are you refering to? Can you cite the scientific references – certainly enologist expect that in their journals.

    Finally, it was long ago that FDA approved antoxidants. It was BHT, they did it because the vegetable fat industry wanted it and found that some plant produced it. That is, at that time they said, if a plant produces it, you can put it in food. So, by that logic, strychnine can be put in food. I could add others to make a long list, but I think most can get the idea. Now BHT is considered bad, Crisco no longer contains it. Antoxidants are a very large group of chemicals which are in general not related to one another. You can be certain that somemore will be found undesirable in a few years.

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  3. Grapedoc, you may not know but a few years back some Ph.D. enologists did not believe 19th century research and made a good start on destroying the California grape (wine) industry. They declared that American roots were not required on European grapes. Of course, Phyloxera took over all of those vineyards. Your moniker looks a little like you were one of those University of California goof balls.

    I have been one of the biggest critics of FDA on LinkedIn. However, your accusations seem to be totally without any supporting evidence. While we have known for at least 75 years that fat is determined primarily by species and then by organ. Yet it is secondly determined by environment. However, that does not prove that diet does not affect accumulation. Clearly, an absolute vegetarian can suffer from malnutrition while eating plenty of calories, but plants produce fats and oils and humans produce their own cholesterol.
    
    To me the noun “transfer” is something (paper) that gives you the right to pay for a ride on a public conveyance, get off and get on another public conveyance without an additional fare. They generally taste unpleasant! The links of excess sugar to both obesity and tooth decay are also on the order of 75 years old. So, what new information are you refering to? Can you cite the scientific references – certainly enologist expect that in their journals.
    
    Finally, it was long ago that FDA approved antoxidants. It was BHT, they did it because the vegetable fat industry wanted it and found that some plant produced it. That is, at that time they said, if a plant produces it, you can put it in food. So, by that logic, strychnine can be put in food. I could add others to make a long list, but I think most can get the idea. Now BHT is considered bad, Crisco no longer contains it. Antoxidants are a very large group of chemicals which are in general not related to one another. You can be certain that somemore will be found undesirable in a few years.
    

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