FDA Warning Letters 2015 Summary

By Curtis Walcker, M.S.
February 4, 2016

In 2015, the FDA issued 80 Warning Letters (WLs) to dietary supplement (DS) companies. This was a 12.68% increase on the 71 issued in 2014. The increase can in part be attributed to the large number of WLs issued to companies marketing products adulterated with non-dietary ingredients such as beta-methylphenethylamine (BMPEA) and 1,3-dimethylbutylamine (DMBA).

Number of 2015 Warning Letters

 

Inspections

Because many of the WLs sent were for the non-dietary ingredient violations, and inspections for those products generally involved review of the labels for ingredients, inspection types categorized as ‘labels’ were significantly higher than other categories in 2015. This did not equate to a proportionally high number of WLs citing label violations.

Inspection types resulting in WLs expanded in 2015. Social media sites have been receiving more scrutiny. The FDA is also looking for claims on online retail sites where companies are marketing DSs, such as Etsy and Amazon.

FDA Inspection Types

 

Geographic Locations

Below are heat maps of the continental Unites States showing the prevalence of WLs received by DS companies by State, as well as which States they were sent from. In 2015, companies in Florida, California, and Utah received the most WLs. The FDA tended to send the most WLs out of the District Offices located in Maryland, California, and Colorado.

2015-FDA-warning-letters-by-state

 

Violations

Disease claims were the most cited violation in WLs for 2015. Non-dietary ingredient adulteration violations were in a distant second place due to some crackdowns on particular ingredients. Violations in current Good Manufacturing Practices (cGMPs) and labels were cited in more than 20 WLs each, indicating continued challenges for companies in both areas.

2015-FDA-violation-types

 

Disease Claims

The FDA cited disease claims violations from a variety of places, demonstrating their increasing concern about what companies are saying and where they are saying it. Product names that were disease claims topped the list along with disease claims made on Facebook. New areas in 2015 include e-books, LinkedIn, and Tumblr.

locations

 

Not much changed in 2015 from previous years in terms of the types of disease claims marketers are illegally using. The top 15 should be no surprise. Combinations of many of these showed up in several of the WLs. The FDA generally only cites disease claims violations in WLs that are clearly explicit.

cited-claims

 

cGMPs

Violations of every Subpart of the cGMP regulations were cited in the 2015 WLs. Production & process controls and quality control Subparts saw the most violations. Companies failing to have adequate master manufacturing records (MMRs) and batch production records (BPRs) continues to be a major problem.

subpart-violations

subpart-violations2

 

Labels

Of the 80 DS WLs issued in 2015, nearly 30% of them cited violations for product labels. This number is likely deceivingly low because so many of the non-dietary ingredient WLs seemingly failed to also cite label violations for the offending products. All 23 WLs citing label violations highlighted errors within the information panels; only 13 involved errors within the principal display panels.

label-violations

One of the biggest label violations of 2015 involved matching the label’s recommended usage of the product to the declared Serving Size. The majority of the top 10 violations were made within Supplement Facts panels. Failing to include proper contact information for the reporting of serious adverse events associated with product use is a prevalent problem among labels.
labels
Note: All information in this article was derived in good faith and is believed to be accurate. Data was collected from all 2015 FDA Warning Letters issued to dietary supplement companies posted on the FDA’s website as of February 3, 2016.

FDA Warning Letter Amended

By Curtis Walcker, M.S.
November 8, 2015

making-the-correctionMany professions require continuing education to keep the professionals in those fields abreast of the trends and evolving research. For us that are involved in dietary supplement regulatory affairs, one of the best unofficial methods of continuing education comes in the form of FDA Warning Letters. A careful reading of these each week not only reminds us of the regulations, but shows us how the FDA is interpreting them, and which issues might be on their radar. In addition, when we are suggesting that our companies or client’s make changes to their manufacturing practices, labels, claims, etc., it can be easier at times to get buy-in when not only the regulations, but also one or more recent FDA Warning Letters can be brought to the discussion table to demonstrate the needs and the associated risks.

This month’s article is a short story about a recent FDA Warning Letter to a Company called New Dawn Nutrition, Inc., (previously) dated 8/7/2015. An excerpt of one of the cited violations for their labels read as follows:

“Your “NDNFA Prime Pure Super Protein” (Cake Batter and Vanilla Milkshake varieties) product labels declare potassium present at “5%” of the Daily Value, phosphorus present at “9%” of the Daily Value, and calcium present at “17%” of the Daily Value~ however, according to 21 CFR 101.9(c)(8)(iii), the percentages for vitamins and minerals shall be declared in increments of 2-percent up to and including the 10-percent level and the nearest 5-percent increment above 10-percent and up to and including the 50-percent level.”

This violation would have been pretty mundane if it was cited for conventional food products, but these were dietary supplements. And for dietary supplements, there is a separate regulation from 21 CFR 101.9(c)(8)(ii), which is 21 CFR 101.36(b)(2)(iii)(C), that reads:

“The percentages based on RDI’s and on DRV’s shall be expressed to the nearest whole percent, except that for dietary ingredients for which DRV’s have been established, “Less than 1%” or “<1%” shall be used to declare the “% Daily Value” when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the “% Daily Value” when rounded to the nearest percent is zero (e.g., a product that contains 1 gram of total carbohydrate would list the percent Daily Value as “Less than 1%” or “<1%”).”

Further, the Dietary Supplement Labeling Guide provides the following:

What rounding rules must I use for expressing the % DV?
You must express the percentages to the nearest whole percent, except that “Less than 1 %” or “< 1 %” must be used when the amount present is big enough to be listed, but so small that the % DV when rounded to the nearest percent is zero. For example, a product containing 1 gram of total carbohydrate would list the % DV as “Less than 1 %” or “< 1 %.”

So why is any of this important? Because the labeling regulations and FDA guidance say that the Daily Value percentages used on the labels above should be rounded to the nearest whole percent, as they appear to have been. However, the FDA Warning Letter was holding them to the rounding used for conventional foods. And if you are a label reviewer that has been doing it one way or the other, this FDA Warning Letter might have led you to believe you have been doing it incorrectly, or worse, reinforced your incorrect rounding.

Because we review hundreds of labels each year, getting the issue clarified was extremely important. Even though it clearly looked like a mistake on the FDA’s part, there is too much on the line to make that assumption. As such, we sent a letter to the FDA District Office with the question. Although it took a few weeks to get a response, their re-review recognized the error. So if you happened to have had a feeling of déjà vu when you again saw the New Dawn Nutrition, Inc. FDA Warning Letter in late September, it was because it was amended to not include the Daily Value rounding violations and reposted on the FDA’s website.

In the end, all is fixed. Anyone that felt their stomachs drop or lost nights of sleep thinking that all of their Daily Value percent declarations were off can rest knowing that it was all just a minor mistake. There are so many label regulations to keep track of, so it is understandable. At Dietary Supplement Experts, we appreciate the FDA’s swift recognition and correction.

If you are interested, the link to the amended FDA Warning Letter is at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458141.htm. In addition to the above item of interest, this one is very insightful on cGMP issues, misuse of the FDA logo, proper units of measure, and the findings of the FDA analysis of some of the products will make you wonder how those violations were not in the mainstream news.

First Seven FDA Warning Letters for Supplement Labels in 2015

By Curtis Walcker, M.S.
March 29, 2015

fda-warningOnly three months into 2015, the FDA has already issued 19 Warning Letters to dietary supplement companies, seven of which cited product label violations. This is the same number of Warning Letters citing cGMP violations. Five companies were cited for both label and cGMP problems. It is not only clear that the FDA is gathering and reviewing labels during facility inspections, but also that companies continue to struggle to label their products compliantly.

In the seven Warning Letters citing label violations, the FDA managed to find problems with every mandatory label component:

Statement of identity: One company did not identify their product with the term “dietary supplement” as part of a statement of identity.

Net quantity of contents statement: One company neglected to include one. Another stated their net quantity of contents in U.S. Customary terms only.

Supplement Facts panel (SFP): All seven companies had issues with their SFPs. These violations included: no SFP, missing or incorrect Serving Sizes and Servings Per Container, zero amount claims, missing dietary ingredients, missing plant parts for botanical ingredients, and declaring (b)(2)-dietary ingredients out of order.

Ingredient statement: One company was missing ingredients in their statement.

Name and place of business: One company failed to include their name and/or place of business on their label as required.

Other: Two companies neglected to include a domestic address and/or domestic telephone number through which serious adverse events associated with the products could be reported. One company was using two languages on their label, but did not repeat all of the required label information in both languages.

In all of 2013 and 2014, the two most common label violations cited in Warning Letters involved inadequate statements of identity and missing plant parts for botanical ingredients. In 2015, the most common one (three of seven companies had this problem) is having the wrong Serving Size in the SFP. Take notice and review this aspect of your own labels. Here is what you need to know:

  • One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or in the absence of recommendations, one unit (e.g., tablet, capsule, packet, teaspoonful, etc).
  • If you recommend one capsule with a meal up to three times per day, your Serving Size is one capsule.
  • If you recommend one to three capsules per day with a meal, your Serving Size is three capsules.
2014 FDA Warning Letters Summary

2014 FDA Warning Letters Infographic

By Curtis Walcker, M.S.
January 20, 2015

In 2014, 31 of 71 (44%) of FDA Warning Letters sent to dietary supplement companies cited label violations. Compared to 2013, the number of label Warning Letters, as well as the percent were virtually the same (30 letters and 45%, respectively). The Supplement Facts panel, ingredient statement, and statement of identity were the label components holding the most violations. Specifically, the most cited violations (by number of Warning Letters) were improper statements of identity, failing to include the plant parts from which botanical ingredients were derived, and failing to declare ingredients in the ingredient statements, such as the ingredients of capsules.

2014 FDA Warning Letters Summary

Share this Image On Your Site

2013 FDA Warning Letters Summary

By Curtis Walcker, M.S.
May 1, 2014

2013 Infographic

 

Share this Image On Your Site