Should You Register Your Labels?

By Curtis Walcker, M.S.
March 8, 2017

Four questions worth asking before participating in the Supplement OWL registry.

I review dietary supplement labels for clients on a near-daily basis – Sunday through Saturday – with very little exception. So in April of 2016, when I saw in the industry news that the Council for Responsible Nutrition (CRN) was launching its Supplement Online Wellness Library (Supplement OWL – http://www.supplementowl.org/index.html) label registry, I was interested. It did not appear to be something entirely different than the NIH’s existing Dietary Supplement Label Database (DSLD – https://dsld.nlm.nih.gov/dsld/).

Admittedly, after a brief read of a news article or two, I did not follow the developments very closely, other than to see it was in beta-testing with a handful of companies. However, this week advertising has ramped up significantly, and according to the site, the Supplement OWL is now accepting labels. As such, it seemed like a good time to try and weigh the risks and benefits of registering labels.

While some of the above sounds fine and possibly helpful, especially for consumers, I struggled to come up with really convincing reasons why I might want to register my labels as a brand owner. In fact, it was much easier to conjure up reasons that registering might not be a good idea at all. Here are four questions worth asking before participating in the registry:

  1. Will my customers find my products in the registry and gain trust in them?

    A lot of things have to line up for this to work out. First, your customers will need to learn about what the Supplement OWL is. Then they have to take the time to use it. And even if they use it, they then need to know how to take the information provided by the registry and interpret it well enough to make informed buying decisions. All of which may not give the slightest guarantee that a product is free of adulterants or manufactured under cGMPs. Will consumers seek out only registered label products? That seems unlikely, but more likely in a scenario where retailers demand registration.

  2. Do I really want to make my labels and information available to the FDA and FTC more than I already do?

    The only public comment from the FDA that is readily found in a NutraIngredients-USA article basically states that the FDA looks forward to learning more about the program, but will continue to focus on compliance throughout the industry. That does not indicate strongly that the FDA would be spending time looking through the registry. However, if the FDA decided that a widely used ingredient was not a legal dietary ingredient for instance, the registry could be used to identify offenders – which is great, unless you might be an unassuming offender. On the FTC side, it is imaginable that they could search out products for something like brain health, and you might end up under more scrutiny than you otherwise might have.

  3. Who else might be looking?

    This is the real question to ask. The Supplement OWL could become a treasure trove to enterprising plaintiffs’ attorneys seeking out product labels with improper Made in the USA claims, arguable natural claims, FALCPA non-compliances, claims questionable in regards to substantiation, and more. Just like they are said to patrol the FDA Warning Letters, a registry with so much information could also open up more doors for these frivolous occurrences.

  4. How much time will it take to participate?

    If you are a brand owner with many labels, it could be a large amount of upfront work, as well as maintenance work. There is a lot of data to enter with each product, and if you have been in the industry any amount of time, you will know that label revisions are made frequently for address changes, excipient changes, ingredient changes, not to mention all of the new Supplement Facts panels that will come in to effect in the not so distant future. The information you enter today could be obsolete tomorrow. You should be prepared to commit significant time to not have outdated information floating around out there.

The above questions and concerns are purely speculative at the moment, but as a brand owner, I think my strategy right now would simply be to wait and see how everything plays out over the next year or so. If you are a CRN member, that might not be an option, as participation appears to be mandatory. However, if you have the luxury of taking it slow, you might keep close watch, and even try to identify some leverage points from the outside, such as more easily monitoring competitor products and surveying entire product categories.

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.

5 Terrifying Label Mistakes

By Curtis Walcker, M.S.
October 25, 2015
FDA PumpkinThis month’s article highlights five mistakes in label compliance that we commonly see in our dietary supplement label reviews.

1. Copying label design from other dietary supplement labels

A tell-tale sign of label design plagiarism is when the label appears to be a hybrid of compliance and non-compliance. Sometimes this is in the form of a nutrition label that says “Supplement Facts” across the top, but then has the design elements for conventional foods. Other times, some label components are very compliant, while others indicate a clear lack of knowledge of the labeling regulations. No matter what the issues are, the bottom line is that copying someone else’s label to create your own is a very bad practice. You never know how well the other company understood the regulations, or to what level they complied with them. Your interpretation of their label as it applies to yours will probably even create further problems.

2. Continuing to make errors just because you always have

When your labels are up for reprinting, it is a great time to send them through the review process with someone knowledgeable about the regulations. If changes must be made for better compliance, do not resist. Just because errors have been made for long periods of time without detection, it does not mean that they are any more correct. If a claim is being made that should not be made, or a Serving Size has been wrongly declared, correct it as soon as possible. Marketing messages and formulations can be adjusted with some creativity. The labeling regulations are far less flexible.

3. Assuming that certain label violations are low risk

Making the assumption that certain aspects of label compliance are lower risk or lower priority than others can be a huge mistake. Many times in our label reviews, clients might not see the purpose of our requested changes, or opt not to make them with their own assessment that the requests are low risk. Our explanation is first the regulations that require the change, and second the fact that the FDA’s label inspections have been increasingly technical over the years, as evidenced by Warning Letters citing seemingly minor violations. Having a Warning Letter come up on the internet when people search for your company is not worth the risk of maintaining label problems for no good reason. Not to mention the growing number of clients we are getting that have their products detained at the borders because of very minor violations.

4. Using the wrong units of measure

This we see a lot. Sometimes it is because the company was not aware of the proper units of measure to use for declaring ingredient amounts; other times it is because they wanted things to appear better on their label. In most cases, when our review finds that something declared in mg, for example, needs to be declares in g, we are met with some reluctance. The company usually does not want to go from declaring 1,500 mg of an ingredient to 1.5 g, even though that is what the regulations might require. Like the mistake above, maintaining something like this might seem minor and low risk, but could find its way into a Warning Letter or cause a shipment to be detained at a border.

5. Making “zero claims”

“Zero claims” are essentially claims made in the Supplement Facts panel that show an ingredient is present at a value of zero (e.g., Total Fat 0 g). These find their way onto labels for many reasons. Sometimes it is label plagiarism, many times it is marketing, and other times companies feel it is required. On conventional food labels, there are requirements for making zero claims. However, on dietary supplement labels, you are not allowed. If you have zeros under your Amount Per Serving heading, they must be removed.

Hopefully none of these frightening mistakes are ones that you are currently making. If you are, it would be worth reviewing them at your next label printings or sooner. Keep in mind that these are just a slim fraction of what we see on a regular basis. If you have questions or need full label review, please contact us anytime.

Label Review Tools Part I

By Curtis Walcker, M.S.
August 10, 2014

toolsIf you are a frequent reviewer of dietary supplement labels, you have probably found that your speed and efficiency increase when you have your “tools” readily accessible. This month we have prepared a two-part series focusing on a selection of the important tools of our trade. If you are not currently using some of these, we help direct you to where you may find them.

Tool #1 – The regulations and guidance documents

These can be located on the FDA’s website. One of the best ways to use the regulations and guidance documents is to bookmark them in your browser. When a label issue arises, you can go straight to the page(s) to look for the answer. Many of the documents are large, so effective word searching is essential to make the task a breeze. The more you access these documents, the quicker you will be able to pinpoint specific regulations.

Tool #2 – A calculator

But not just any calculator – a percent Daily Value calculator. If you are currently using a regular calculator for determining your declarations, you are wasting far too much time. Using a program such as Microsoft Excel, you can create your own spreadsheet, where you can enter in the label values for nutrients and it will give you the percentages. A proper and efficient one will be built so that all of the nutrients are already in the order that they must be declared on the label, the correct nomenclature is used, the defined units of measure are used, and the numbers are automatically rounded to the nearest whole percentages. Not up to building one or just need a better one? Download one that can do all of the above for free here.

Tool #3 – The FDA Warning Letters

If you currently are not reviewing the FDA Warning Letters to dietary supplement companies posted each week, you are truly missing out on one of life’s great pleasures. Not only can they be entertaining, they can also expose you to regulations you may not have been aware of, remind you of regulations you have forgotten about, and help you gather regulatory intelligence regarding trends in what the FDA is looking at. The Warning Letters are a great tool for continually self-auditing your own skills and improving your label review expertise. Visit the FDA Warning Letters page to access past Warning Letters and sign up for e-mail updates so you never forget. Access and cite these when needing to support your assessments and edits.