Top Supplement Label Errors of 2020

By Curtis Walcker, M.S.
January 24, 2021

In 2020, we saw 20 FDA Warning Letters posted citing label violations for dietary supplements. We tallied up all of the violations cited and put them into a single chart. For the most part, these are the same violations we see year after year. However, there were a few things worth taking note of. Here is what we found:

What was familiar?
We do tracking and compiling of FDA Warning Letters each year, and with regard to label violations, everything was pretty familiar. FDA was able to grab the same old low-hanging fruits that brands still find challenges with. As with years previous – incorrect common or usual names, missing plant parts for botanicals, missing ingredient declarations, and incorrect use of bars and hairlines topped the chart with very high numbers. Things like zero claims, intervening material, and the use of footnotes that should not be present can typically be traced back to brands trusting the templated system-generated Supplement Facts panels supplied to them by their manufacturers, or worse – copying competitor labels. No matter what the reason behind errors, the Warning Letters get addressed to the brand on the bottle, and not manufacturers or competitors. Shoring up label compliance is definitely one of the fastest and easiest risk-reducers for any brand.

How did our client labels compare?
New client labels were very similar in terms of what issues we resolved, and frequency in which they occurred. The great thing that occurs with returning or existing clients is that within a few labels together, the client begins removing template errors across all of their labels proactively, so our reviews become more streamlined and focused on product-specific errors. For instance, once a client figures out that they were missing serious adverse event reporting information on a couple of labels, they go back and put it onto all labels.

What stuck out?
More than anything, this is why we track Warning Letters and violations the way we do. You can go read the laws and regulations all day long, but Warning Letters shed light on what the FDA is focusing on, and how they are interpreting things. While nothing was really new here, beyond the usual violations, these three stuck out:

  1. Trade names are not permitted within the Supplement Facts panel.

    This may come as a big surprise to virtually all brands…and manufactures…and raw material suppliers. However, it is the case. The information panel of a label generally bears the Supplement Facts panel, ingredient statement, and name/place of business, and major food allergen labeling when applicable. All of these items are regulated in terms of their contents, placement, and formatting. Adding anything beyond what is required, becomes at risk of being what the regulations refer to as “intervening material”. And anything intervening and not required by the regulations is generally not allowed.

    In the Warning Letter to Market America, Inc. for instance, FDA noted to them that referencing their trademarked ingredients (SunActive® and Quatrefolic®) within the Supplement Facts panel was not permitted – referring to it as intervening material.

    This does create a bit of a conundrum. A brand invests more into their product with trademarked ingredients, and they want to let their consumers know. However, for FDA compliance, the Supplement Facts panel should not be that marketing vehicle. There are many other places more suitable on the label or in the labeling for marketing callouts.

  2. “Herb” and “aerial parts” are not acceptable plant parts to declare for botanicals.

    Again, probably surprising to a lot of brands. We see this come through on labels weekly. Plant part(s) declared for botanicals need to be specific. Understandably, FDA told R-Garden, LLC that “Cleavers herb” was inadequate, as “herb” is not a plant part. Less understandable, however, ForYou, Inc. and BHP Holdings, Inc. were told that “aerial parts” was also inadequate. The industry tends to use “aerial parts” when plant parts used consist of all parts above ground – much like “whole plant” is used when all parts are used. The challenge in labeling aerial parts one-by-one is that the lists could become long and ultimately be more misleading when parts are left out of the list. This is one we’d like to see some more clarity from the FDA on what exactly they are looking for.

  3. If a footnote in the Supplement Facts panel is not required, it is not allowed.

    This one is usually just a template error, usually passed along by a manufacturer, but a risk nonetheless. We see many Supplement Facts panels with both of the typical footnotes, “Daily Value not established” and “Percent Daily Values are based on a 2,000 calorie diet”. However, either one is only required and only allowed when it applies based on what is declared. FDA let LifeHealth Science know this, when they sent them a Warning Letter stating that their footnote was not permitted, as nothing declared required it.

If you recognize any of these errors in your own labels, or are unsure, we are here to help. We offer very affordable label compliance review service, fast turnaround times, and bulk discounting for multiple labels. Contact us today!

CFUs or Milligrams for Probiotics?

By Curtis Walcker, M.S.
September 24, 2018

It’s the age-old label debate – Marketing wants to declare probiotics with CFUs, Regulatory want to declare them in milligrams. Marketing has strong arguments for CFUs – the studies report in CFUs, CFUs make sense for comparing products, competitors use CFUs, and so on. The Regulatory argument is that the regulations require milligrams. So, who is correct? Technically, the Regulatory argument wins here, but as of late, there is more to this story.

Historically, the regulations have required that ingredients such as probiotics 1) be declared with quantitative amounts by weight per serving, and 2) that those amounts be expressed using metric measures in appropriate units, which in most cases for probiotics means milligrams. However, after 20 or so years, the FDA proposed much needed changes to the existing nutrition labels. In the comments submitted, the request was made for the FDA to consider allowing additional units of measure when metric weight is not the most appropriate. Examples given were CFUs for probiotics, and enzyme assay units for digestive enzymes. The FDA responded:

“We decline to permit the use of additional units of measure for dietary ingredients. The comment provided the examples of CFUs for probiotics and enzyme assay units for enzymes; however, the broader change suggested in the comment, by including “other appropriate units of measure,” would allow for the use of units of measure for dietary ingredients other than just probiotics and enzyme assay units.

We recognize that manufacturers are using a number of different units of measure for probiotics, enzymes, and other dietary ingredients. We need to fully evaluate each unit of measure for dietary ingredients to determine if it is appropriate for use on the Supplement Facts label, and if there are any implications to allowing for the use of such units of measure on the label. Because of the complexity of these labeling concerns, we plan to issue information related to this subject at a later date. We have, therefore, finalized § 101.36(b)(2)(ii)(A) without change.”

In early September 2018, the FDA released its Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials. In this document, the FDA states that they intend to exercise enforcement discretion for companies that choose to declare CFUs in addition to weight for probiotic ingredients if the following seven conditions are met:

  1. The quantity is first listed in terms of weight;
  2. The declaration of quantity in CFUs is expressed in a manner that is clearly separate and readily distinguishable from the weight, e.g., as a parenthetical or in a subset line;
  3. The declaration of the quantity in CFUs is formatted in clear terms that can easily be understood by a common reader, e.g., 10 billion or 300* (where the unit that “*” is intended to represent is a typical measurement of CFUs and is clearly indicated elsewhere in the Supplement Facts label);
  4. The declaration of quantity in CFUs is accurate and not misleading, does not render misleading other aspects of the Supplement Facts label, or other aspects of the product label;
  5. The declaration of quantity in CFUs measures only live microbial ingredients and does not include inactive, dead, or nonviable organisms;
  6. Live microbial dietary ingredients in a proprietary blend are listed in descending order of predominance by weight; and
  7. The product label otherwise complies with all applicable laws and regulations.

Moving forward, it seems that both Regulatory and Marketing groups get what they want for Supplement Facts panels now when it comes to probiotics. The question that remains is how should a compliant label look with both CFUs and milligrams declared? Here is our interpretation for single and dual line declarations:

How Much Does Dietary Supplement Label Review Cost?

By Curtis Walcker, M.S.
February 22, 2018

Since 2013, we have set our fees based on what we feel is fair to the client. FDA label compliance review was actually the very first service we offered, and remains among the most popular. Our fee for label review has been a flat $399 per label, with usually one to three days turnaround time for years. For the vast majority of labels, this works out well for the client, but also for us. We do not experience many hagglers or complainers. In fact, we more often have people asking us why we charge so little!

This is a good question, especially as we set our fees without surveying the competitors or trying to undercut anyone. Honestly, we really did not have a clue what exactly others are charging for this service until recently. A client that chose us to review their labels shared what they found when they priced the project out with every label review company they could find with Google searching. The results were in most cases shocking, and borderline sickening in others. The insight was valuable enough that we want to share with you what was shared with us.

Comparative Pricing for Single Dietary Supplement FDA Label Compliance Review:
Competitor #1: $3,500
Competitor #2: $2,500
Competitor #3: $1,495
Competitor #4: $1,200
Competitor #5: $995
Competitor #6: $950
Competitor #7: $750
Competitor #8: $750
Competitor #9: $725
Competitor #10: $500
Dietary Supplement Experts: $399

It makes sense now why clients ask us why our prices are so low – given that we charge $399, and 10 of our competitors range from $500 to $3,500. Here are a few thoughts on what creates these discrepancies.

  1. We do not outsource or subcontract to other firms. This is a dirty little secret of the dietary supplement consulting business. We are a close knit team with very niche skills, and are very careful about who we let on the team. However, you might be surprised to know that we are subcontracted by several of our competitors for all of our services. The rates we charge them are the rates we charge you directly. Our consulting firm clients generally charge you 2-3 times that price. Ever pay $1,200 for a label review? We probably did it for your firm for $399. We won’t name names, but does you current firm have a tradeshow booth or advertise heavily? Let us quote your projects at a fair value first.
  2. Tradeshow booths, Google, and trade publication advertising is not cheap. Neither are office spaces or massive headcounts. To a large extent, we have grown by word of mouth. We invest very little in advertising, and our team works remotely. We simply do not create the overhead costs that our competitors have. We focus on making you the client satisfied, which in turn has allowed us to consistently grow year after year.
  3. We have all worked for dietary supplement companies. We know what it is like to be a start-up with a small budget. We know what it is like to receive a regular hourly wage. We trade time for money as consultants, and it is difficult to justify billing clients some of the rates we see out there. We try to balance the cost to benefit ratio to create win-win situations and clients for life.
  4. We are not lawyers! When you have legal issues, we will be the first to direct you to a legal professional that we know and trust. However, the vast majority of dietary supplement formulations, compliance, and other project types do not require a lawyer to do the work for you. And guess what, sometimes even they subcontract to consultants anyway.

Whether it be label review or any other compliance service you are looking for, we hope this article will give you some context of pricing discrepancies. Of course price should not be your prime consideration. Make sure your chosen experts know what they are doing. We always appreciate the opportunity to earn your business.