Tune Up Your FDA Compliance!

It’s difficult fix a problem if you don’t know there is one to begin with – which is the case with many clients we work with. So, we’ve compiled a brief set of checks that you can quickly and easily self-audit with. While very far from being all-inclusive, these checks touch on some of the lowest-hanging fruits and most common violations seen. If you recognize one or more with your brand, it doesn’t guarantee you are violating regulations, but it would be a strong indication that you have something to look at.

Red Flags

Labels:

Are any of your botanical plant parts declared as “aerial parts” or “herb”?
Are there any zeros (e.g., 0 mg or 0 g) in the Supplement Facts panel?
Are you missing a U.S. phone or address where adverse events can be reported?

Claims:

Are you making explicit or implied claims about COVID, flu, or cold?
Do you have any unqualified inflammation or pain claims?
Are you making claims about hangovers?

Manufacturing:

Do your certificates of analysis (COAs) list “by input” as the only testing method to ensure label claims specifications are met?
Is your manufacturer registered with the FDA?
Do you not have and follow your own set of written procedures (SOPs) for things not conducted by you manufacturer or other contracted partners (e.g., returned dietary supplements, product complaints, reserve samples, supplier qualification, etc.)?

Ingredients:

Does your product contain cannabidiol (CBD)?
Does your product contain n-acetyl l-cysteine (NAC)?
Does your product contain kratom?

Could you answer “yes” or even “I don’t know” to any of these? If so, it’s not necessarily a reason to panic, but you should be concerned. Sometimes brands take calculated risks because the potential reward might out-weight them. But other times, they take uncalculated risks because they are unaware, see other brands doing something, or they are just marketers that do not know or care about following the rules. In any case, we are here to help. If you have something questionable, we can help determine if you are at risk, explain to you why you are at risk, and help you make the corrective actions to reduce or remove the risk. Contact us today to get a free assessment of your situation.

Label Review Tools Part 2

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:

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.
“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.
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:

The quantity is first listed in terms of weight;
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;
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);
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;
The declaration of quantity in CFUs measures only live microbial ingredients and does not include inactive, dead, or nonviable organisms;
Live microbial dietary ingredients in a proprietary blend are listed in descending order of predominance by weight; and
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 $499 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: $499

It makes sense now why clients ask us why our prices are so low – given that we charge $499, and 10 of our competitors range from $500 to $3,500. Here are a few thoughts on what creates these discrepancies.

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 $499. 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.
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.
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.
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.

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:

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.
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.
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.
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).

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.

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.

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.

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.

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.

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.

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.

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.

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 (Updated October 29, 2017)
This 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.

Update: The old label regulations read, “These amounts shall be expressed using metric measures in appropriate units (i.e., 1,000 or more units shall be declared in the next higher set of units, e.g., 1,000 mg shall be declared as 1.1 g).” The new label regulations remove the example language, and now only reads, “These amounts shall be expressed using metric measures in appropriate units.” Time will tell how the enforcement will change.

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

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. 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.