FDA Warning Letters this week 11/2/17: A gift from FDA to QA staffers reviewing product labels

The week goes by and new letters come out. Below I’ve selected a few of the food-oriented warning letters and discuss/explain some of the more interesting findings.

Don’t know what warning letters are? Check out this post for a brief overview of what they are and why FDA sends them out.

WL# 17-ATL-12

Subject: Food Labeling/Misbranded/False and Misleading

The labeling requirements for food are so complicated, that the guidance documents for them are in the hundreds of pages. It’s the responsibility of those folks involved in compliance to review labels and claims to ensure that their company doesn’t end up in trouble, but that can mean being the bearer of bad news. While QA/regulatory folks get buried in the details, other stakeholders only understand labels from what they see in the market from products they buy or competitor products.

Oftentimes, QA folks have the fun job of saying “that’s not technically what the law says”. This is the risk assessment version of label review. The next step then, is risk management, in which other folks may ask the question of whether FDA/FTC are actually enforcing these rules, some of which are nestled in very grey areas and/or not commonly followed!

Often when evaluating the enforcement side of the law, good QA personnel turn to warning letters to see which portions FDA is actually enforcing. Unfortunately when labeling is enforced on the food side via warning letter, it’s never for the soft grey area stuff. FDA mostly enforces misrepresentation of product, health/function/unapproved drug claims, having components straight up missing (e.g. “you didn’t have an ingredient statement“), or allergen mislabeling (which is a food safety issue). We get very few examples where FDA has actually verified nutrition values (for which there wasn’t a claim), corrected serving size errors, or identified other interpretation issues.

So, in a blog that offers plenty of criticism, let’s take a moment to say:

Thank you FDA!

Visible enforcement actions on labeling deviations help everyone keep their marketing teams in check. Regulatory professionals have so much more ability to push for accurate and fair labeling  when they can actually demonstrate that it’s being enforced elsewhere.

Okay, so exposition over, let’s get into the actual findings of this warning letter:

In June, 2017, FDA actually collected a sample of this product (crackers) from a retail store and tested it for nutrition against the values in the nutrition facts panel.

This is super cool. And while FDA is clear in the regulations that it has this power (and explains to manufacturers how these samples are collected) you never really hear about it happening.

 The product label states one serving is one package/ 6 crackers and contains 10% of the Daily Value for iron. However, the sample analysis performed by FDA found the product to contain 51.7% (original) and 57.2% (check) of the declared amount….Based on these findings, your product is misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading. Specifically, the iron content is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)].

Okay, so real quick and dirty discussion about nutrition labeling and how far your numbers are allowed to be off.

How far off from label is too far?

Basically, while still operating within “good manufacturing practice”, FDA created three groups of ingredients.

Class I ingredients  are vitamins and minerals that are added to “fortified” foods. These are ingredients that consumers see as beneficial, that you’ve now made marketing claims about, and that you would have a economic incentive to over declare. So  when your food is tested, these nutrients need to be present at 100% of the labeled level or higher. If you say it has 40mg of vitamin C, you better have at least 40mg. It can contain 50 or 60 with no problem, but it shouldn’t ever be below what you’re claiming, which would be interpreted as misleading your customer to sell more products without adding the ingredient.

Class II ingredients are the “good” stuff in normal foods that aren’t claiming to be “fortified”. Things like vitamins, minerals, protein, total carbohydrates, dietary fiber, unsaturated fat, and potassium that people like to see in their food (e.g. “I’m looking for a high protein snack“). These again are “beneficial” ingredients to consumers, so you would have an economic incentive to say they were higher than they actually are (or over declare them). When your food is tested, these nutrients need to be present at 80% of the labeled level or higher. If you say it has 8g of protein per serving, FDA gives you a little wiggle room since values will vary between crop years etc. (potatoes will change a little year to year based on rain etc.), but would rather you under declare to make sure no one is misled by the label.

Class III ingredients are the “bad” stuff that people are trying to avoid. Things like calories, total fat, saturated fat, cholesterol, and sodium (and sometimes carbohydrates/sugars). These you would have an incentive to under declare or say there was less of the bad stuff than there really was (40 fewer calories per serving than our competitors!). When your food is tested, these nutrients need to be present at 120% of the labeled level or lower.

Back to the letter…

So this company got in trouble for violating the rule for class II ingredients, in that the actual tested value for iron was more than 20% less than the label said. Assuming that this was an honest mistake, this company would have done well to truncate their labeled values for iron downward, as FDA says in their guidance:

Reasonable excesses of class I and II nutrients above labeled amounts and  reasonable deficiencies of the Third Group nutrients are usually  considered acceptable by the agency within good manufacturing practices.

So don’t just label your protein as zero to make sure you don’t get in trouble, but if you tested at 2 grams and decided to label just 1 gram to make sure you were good to go, FDA is okay with that.

The information panel labeling does not meet the requirements in 21 CFR 101.2(e) because the bar code is intervening material within the ingredient list.

The “information panel” is a term that refers to the section of the label you decided to place the nutrition facts, ingredient statement, and place of manufacture. Technically it appears directly to the right of the “principal display panel” which is what you see facing you on the shelf, but that rule is very rarely enforced provided you don’t deliberately hide it.

The nutrition facts, ingredient statement, and place of manufacture (signature line) have a requirement that they all need to be touching each other with “no intervening material”. This is a common one for companies trying to make their labels look pretty to mess up. Things like logos, preparation instructions, or romantic copy (things like company story or description of the product) can’t be stuck in there between your ingredients, nutrition, and contact info, they need to be in one single unit so that people don’t need to go looking for them all over your package.

Intervening material...is a crisis
See how you can’t separate out the regulatory portion with “stuff”?


The product label does not declare the street address of the firm. Under 21 CFR 101.5(d), the street address is required unless it is shown in a current city directory or telephone directory.

We don’t have the label to review here, so we can’t say what information was on the label. But I have a haunch as to what happened with this product. It’s for sale on Amazon in large multi-packs, but fda stated that their package was 1.75 oz. I’m guessing complete contact info was available on the larger, bulk package, but the retailer was selling individual 1.75 oz packages. They may not have included all info since they didn’t wholesale the individual packets, just the cases. But since the individual packets were consumer facing packaging, they are required to contain all the pertinent information just like every candy bar and stick of gum.

On a separate note, in the internet age, the 1994 standard of “shown in a current city directory or telephone directory” is absolutely an obsolete one. I can readily find this business and contact information online, and it’s silly to assume that the same access isn’t available through the internet as a phone book. The minimum standard of name/city/state/zip is still helpful to search for businesses with generic names that may be harder to find.

As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Although FDA has proposed  to extend the initial compliance dates of July 26, 2018 or July 26, 2019 (depending on the size of the manufacturer), manufacturers may begin revising labels now to meet the new requirements.

Bold, FDA….bold.

This isn’t a finding, just a comment that FDA would like to see the updates to this label include switching to the new nutrition facts panel format.  However, I take issue with them trying to rush this particular manufacturer given that FDA is supporting extension of the deadlines despite many manufacturers already having completed in the 16 months since the rule became final, and the original deadline still 9 months out for large businesses.


This is a great warning letter to keep around. It’s a clear example of FDA both performing market surveillance on single serve products for compliance, as well as actually testing products to compare to the nutrition facts panel in the absence of a nutrition claim, which is very uncommon.

For businesses evaluating their labels for risk of enforcement, I offer the following business risk approach if you find yourself making decisions in the “grey area”.

  1. Food safety issues are non negotiable. Label content must NEVER put a consumer at risk.
  2. Has this issue been enforced based on the evidence available in warning letters or class action lawsuits?
  3. Is your product at “high risk” for label scrutiny by either FDA or consumer advocacy groups? Labels that are easy targets are those that: are dietary supplements, are fortified, contain nutrition claims on the label, contain health claims on the label, is intended for children, or are connected to a brand that makes nutrition/health connections in their marketing materials or website.
  4. Does the discovery of your use of the “grey area” show that you had an economic motivation to stretch the rule? I.e. did you deliberately mislead potential customers in order to gain a business advantage over your competitors or current industry trends?
  5. Is your decision defensible within the “must/shall” of the CFR?
  6. Always ask your marketing team, why do you want this? If the answer is that not doing it would affect purchase intent, that’s an obvious sign that consumers do value the issue, and you’re intentionally misleading customers.

Use these questions to decide how hard to push for the “spririt” of the labeling regulations, which is always to protect consumers from misleading business practices, as well as encourage fair competition among food producers.

Sell your product, not the label.


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