Label Review Tools Part 2

By Curtis Walcker, M.S.
July 20, 2021

If 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. All the way back in 2014, we published the Part 1 to this article, and are finally making good on the Part 2. The previously named tools included 1) the regulations and guidance documents, 2) a calculator for percent Daily Values, and 3) the FDA Warning Letters published weekly. Here are three additional tools to use and where to get them.

Tool #4 – Herbs of Commerce
It is pretty tough to properly label botanical ingredients without this critical reference tool. In fact, 21 CFR 101.4(h) actually requires that the common or usual names of dietary ingredients that are botanicals (including fungi and algae) be consistent with the names standardized in Herbs of Commerce. It can be purchased through the American Herbal Products Association’s website here. You will be amazed to find how many “common” names used for botanicals are not technically appropriate for labeling.

Tool #5 – FDA’s high-resolution Supplement Facts panel examples
We share the link to this tool with clients and designers maybe more than anything else. And while you must have some knowledge of required formatting and when and where to use certain formats, the FDA’s High-Resolution Examples of Different Supplement Facts Labels in the New Format is invaluable for quickly viewing a range of Supplement Facts panel types. This is a far safer model for your own labels than competitor labels!

Tool #6 – A (NEW!!) % Daily Value calculator
Although this is the same tool we recommended in the Part 1 of this article, enough time has passed that the labeling regulations have been changed, and with them came many new Daily Values and even units of measure. So once again, 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? Our newest version can be downloaded for a small fee here.

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.

Forced Non-Compliance?

By Curtis Walcker, M.S.
February 18, 2018

At a time when the dietary supplement industry faces ever-growing scrutiny, there is a lot of discussion about what can be done from within the industry to self-regulate. Despite having arguably adequate regulations in place, many would agree that the low level of enforcement of those regulations might be the biggest issue. And while the appropriate enforcers (e.g., FDA and FTC) may not have the resources necessary to police the entire industry, others have stepped up (e.g., State AGs, plaintiffs’ attorneys, task-force groups, etc.) with varying agendas. As those outcomes rarely serve the industry or its consumers well, we have seen more movement towards industry self-regulation. These self-regulation efforts include things like mechanisms for challenging advertising claims among competitors, unofficial cGMP standards for raw materials suppliers, and repositories for label and manufacturing data. The end results of which will hopefully promote more compliance with dietary supplement manufacturing and advertising, but also improve consumer confidence in the products and industry.

Industry self-regulation is fantastic, but not the topic of this article. The topic is actually the opposite – industry self-deregulation. That’s right. While regulatory affairs and quality professionals work tirelessly to make and keep companies compliant with the regulations, there are active forces from within our own industry that not only promote non-compliance, but also force it upon companies with contracts and refusals to do business with them.

Now these might sound like strong accusations, but they are in fact very real, and far too common. However, it must be said that those involved in creating the instances of forced non-compliance are generally not aware of what they are requiring, or sometimes just of the opinion that the compliance issues are insignificant in terms of risk.

These forced non-compliance issues can be seen from time to time in all of the critical regulated areas such as labels, claims, and manufacturing. At DSE, a lot of our consulting work focuses on label compliance reviews, so I’ll present some of the areas where we see this frequently with clients in the label area alone.

  1. The first offender can be your contract manufacturer. The majority of dietary supplements on the market are made by contract manufacturers. As a brand owner, it is your duty to ensure that your products are made in compliance with the cGMPs. To earn your trust and business, contract manufacturers invest heavily in the equipment, quality control, and expert personnel needed to make dietary supplements. However, it is quite rare that they further invest in an expert to make sure that your labels are compliant – as they are squarely your responsibility. They will generally provide enough information on your product that a compliant label can be made.

    A good manufacturer will disclaim this, and recommend you seek expert help with your label. A dangerous manufacturer will lead you to believe that sticking their content on your label without further review will guarantee compliance. The most dangerous though, are the ones (especially the private labelers) that will not release your product to you until they have provided a review of your label, and will reject your label for any slight deviation from what they want from you. In every case of this that we see, the manufacturer has demanded that the client 1) not be allowed to use a compliant label, 2) maintain their non-compliant Supplement Facts panels and/or ingredient statements, and 3) forget about the product if the labels aren’t approved. It creates quite a conundrum for clients.

  2. The second offender can be you raw material supplier. This usually only occurs when your product contains a trademarked material. While you pay the additional price of using these ingredients for better marketability, claims support by clinical studies, and overall better compliance – you might end up being forced right back out of label compliance.

    The way this happens is that in order to use the trademarked ingredient, the supplier will require you to sign a trademark usage and licensing agreement. In this contract, at times you will be required to label the ingredient in a very specific way in your Supplement Facts panel that might not be in a compliant manner. This might violate the regulations in terms of the naming of the ingredient (not a common or usual name, or not a standardized common name for a botanical ingredient), usage of intervening material (added marketing language or trade name), or something different. Before printing your labels, the suppliers want to review and approve your labels. If you have deviated from the agreement, they may reject your use of the material based on the labeling.

  3. The third offender can be your retail distributor. When your products find their way to retail distribution, part of the process can include label review. We have helped out with label compliance readiness for many companies in retail, and have seen the varying degree of expertise displayed by the retail reviewers. The ones that are extremely technical and conservative are our favorite, but those that come back with comments for change that are outside of compliance are difficult to deal with. Sometimes this seems to be confusion with conventional food labeling rules, other times it can be less clear where it involves maybe just misinterpretations of the regulations, or drawing from the non-compliant practices of other brands currently distributed by the retailer. In any case, retail distribution is a big thing, so trusting them and complying is an easy approach, but creates risk nonetheless.

So what is a company to do when unnecessary label non-compliance is forced onto you? To start, you must know the regulations to have a chance of fending it off, or at least someone in your corner that does. Then, when it happens, hopefully you can present a reasonable case to the offender, and get them to recognize their error and make a compromise. In the best of cases, they may appreciate your perspective, and possibly appreciate the challenge and outcome. In the worst of cases, they might be inflexible, and you might need to navigate away.

If you need a second look – or even first look – over the compliance aspects of your dietary supplement products, please contact us and see how we can help.

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.

Changing RACCs and the Implications

By Elaina Paniagua
September 11, 2016

beverage-labelsOn May 20, 2016, the FDA announced that it has finalized new rules that will make significant changes to nutrition labeling for the first time in more than 20 years. The two final rules that the FDA is issuing pertain to food and supplement labeling as well as a rule that will amend reference amounts customarily consumed (RACCs) and regulations around serving sizes. These changes are made to help consumers make better informed decisions about the food they eat.

So how do the new regulations affect you?

There are several changes to the new regulations when it comes to food and supplement labeling, but one of the most pertinent changes are the adjustments to RDIs/DRVs. Seven RDIs increase, sixteen decrease, three remained unchanged, and one was added. For DRVs, three remained unchanged, two increased, two decreased, and one was added. The significance of these changes affect the ability to make nutrient content claims. For example, increased DRVs such as fiber going from 25 to 28 grams can effect what is considered “excellent source,”20% of the DRV is what is needed for manufacturers to claim “excellent source,” however with the new DRV increasing to 28 grams what was considered “excellent” in the past is no longer compliant based on the new standards (i.e. 5 grams of fiber is now only 18% DRV).

When it comes to the changes regarding RACCs and the regulations around serving sizes there are several updates. First, there are 30 changes to the current 159 RACCs, with an additional 25 being added to the list. The FDA’s rational for updating the rule is because they recognize the amount the average American consumes in one sitting has changed since the first established RACCs in 1993. An example of the updates include ice cream which has changed from one- half cup to two-thirds cup, this means consumers will see a higher caloric number displayed based on the new RACC amounts. The new rules will also change how manufacturers label single-serve and multi-serve packages. Under the new amended rule, any food that contains less than 200 percent of the RACC must be labeled as one serving. The new rule also changes multi-serve packages because manufacturers with products that contain 200-300 percent of the RACC will now have to display dual column nutrition facts panels that provide both “per serving” and “per package”. These changes not only affect a manufacturer by needing to verify claims, but it also draws more attention to caloric content as well as other nutrients such as sugar, sodium, and fat on the packages which has been a topic of conversation for some time.

The new updates given by the FDA this year give a two year period for compliance for companies with $10 million or more in sales annually, and three years for companies under the $10 million annually. With both of the final rules becoming effective as of July 26, 2016 manufacturers must begin to look at their levels of compliance based on these new changes and how it will ultimately change the nutritionals and the marketing for their products.

For assistance with your food or dietary supplement labels Contact Us

New Supplement Facts Panel

By Curtis Walcker, M.S.
June 13, 2016

New-ImprovedAfter a long wait, the FDA announced on May 20th, that they have finalized the new regulations for the Supplement Facts panel. Many changes are taking place in the Daily Values, units of measures, nutrients to declare, naming, order of nutrients, and more. While there is some time to use up current label inventories, we are suggesting that clients make the appropriate changes as soon as their next label printings. This is a great opportunity to not only get your Supplement Facts panels compliant with the new regulations, but clean up the rest of your label components as well.

Read what is new with dietary supplement labels here.

View the details of our complete label compliance review service here.

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.

Structure/Function Claims Basics

By Curtis Walcker, M.S.
December 9, 2015

Structure Function Claims BasicsCommunicating the features and benefits of your dietary supplements is a critical success factor. Although this can be done in several ways, the most powerful is usually through the use of structure/function claims. A common misnomer about these claims is that virtually anything can be said as long as the FDA disclaimer language is added to the label or labeling. Unfortunately, this is far from the truth. There are regulations that put significant limitations on what can be said, and it is truly an art to not only saying things compliantly, but also in ways that are meaningful to consumers. Here are some of the most basic aspects of structure/function claims.

What are structure/function claims?

Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of humans, or characterize the documented mechanism(s) of action by which a nutrient or dietary ingredient acts to maintain such structure or function. Importantly, they cannot be disease claims. Structure/function claims may also relate to nutrient deficiency diseases, or describe the effect of the dietary supplement on general well-being.

What are disease claims?

Dietary supplements and their ingredients cannot be marketed with the intentions to diagnose, mitigate, treat, cure, or prevent diseases (other than classical nutrient deficiency diseases). Doing so creates disease claims. By the definition given in 21 U.S.C. 343(r)(6), “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.

Q: Which of the following is the disease claim?
1) Product X treats diabetes.
2) Product X promotes healthier blood sugar.

A: Both are very likely to be considered disease claims. Did you choose 1? Disease claims can be explicit or implied. They need not mention specific disease names such as diabetes.

What laws and regulations govern structure/function claims?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law states that a dietary supplement may bear structure/function claims and provides their requirements. Further, 21 CFR 101.93 also restates these requirements.

What are the requirements for using structure/function claims?

  1. You must have substantiation that the claims are truthful and not misleading, and you must have this substantiation before you make the claims.
    • Refer to the FDA and FTC guidance documents for preparing competent and reliable claims substantiation, or get help from someone who can prepare these files for you. You do not want to be caught without them.
  2. You must notify the FDA that you are using the claims within 30 days of first marketing your product.

    Q: Do you really need to do this?

    A: Yes. Many companies overlook this important requirement for making structure/function claims.

  3. You must include the mandatory disclaimer for structure/function claims.
    • Text for the disclaimer when one claim is present: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
    • Text for the disclaimer when more than one claim is present: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
    • The disclaimer must be placed adjacent to the claim(s) with no intervening material or linked with a symbol (e.g., an asterisk) at the end of each claim that refers to a symbol placed adjacent to the disclaimer.
    • On product labels and labeling, the disclaimer must appear on each panel or page where structure/function claims are made.
    • The disclaimer must be set off in a hairline box when it is not adjacent to the claim(s).
    • The disclaimer must be in bold type and no smaller than one-sixteenth inch.

While these basics do not cover everything you must know when making structure/function claims, they give you a good start towards regulatory compliance. For a bit more, see our April, 2015 article Supplements Claimed to Treat 100+ Diseases. It highlights some places claims exist, as well as some of the most prevalent claims cited in FDA Warning Letters.