Dietary Supplement Manufacturer

Starting a Supplement Company – Part 3: Finding a Manufacturer

Dietary Supplement ManufacturerIn this series, we are briefly going over each of the steps we are assisting a new client with creating and launching their new dietary supplement product for their new dietary supplement company. In the last installment, we reached client approval on the product formulation, and created a purchasing specification that could easily be sent out to potential contract manufacturers to quote pricing on.

The purchasing specification we create is very similar to the finished product specification that will need to be created, but omits some of the needless details such as methods for determining that specifications are met, and areas for QC signatures. However, it is detailed enough so that little if anything is left to interpretation in the quoting process. The purchasing specification should contain all of the details for the packaging components such as bottle size, bottle color, plastic type, lid type, scoop size, seals to be used, desiccants, etc. For the actual dietary supplement, you should include things like the dosage form, net quantity of contents, Serving Size, ingredients to be used, label claims to be met, and any other information that ensures that the product is formulated correctly. You might also include what is not allowed, such as certain allergens, non-organic materials, types of fillers, etc.

Because we have relationships with so many contract manufacturers, and routinely visit many of them on behalf of our clients, we selected three that would be good potential fits for this client, and sent them the purchasing specifications for quoting. One manufacturer’s response and excitement for this new unconventional product was so good, that even though their pricing was a little on the high side, our client wanted to move forward in qualifying them as the supplier for the project.

The client, using our set of standard operating procedures (SOPs) for an own label distributor (SOPs to be discussed in a later piece), completed a paper audit, and gave the supplier a preliminary qualification pending an on-site visit. The client contracted us to go with them to the facility to conduct a full audit, and it went very well. Although tedious and overlooked by many, qualifying (and re-qualifying) your suppliers is a requirement of the current Good Manufacturing Practices for dietary supplements. The purchase order was made shortly after the visit.

Once the purchase order was made, and a 10-12 weeks lead time was assigned, there was much to be done in the meantime. Stay tuned for the next steps in the process. If you need assistance with creating purchasing specifications, qualifying your suppliers with paper or on-site audits, or referrals to manufacturers we know and trust, contact us today!

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.

Starting a Supplement Company – Part 2: Custom Formulating Dietary Supplements

If you recall our last post, we are sharing a new series of articles that will cover the variety of consulting services we are providing a new DSE client. They were telling us the target audience for their first product, giving us some steep specifications to meet, and requesting we handle many things from the formulation through the launch of the product.

The first step of the project was to come up with a few product formula concepts. In doing this, we followed our basic 8-step process for custom formulating dietary supplements that deliver on uniqueness, marketability, strong claims, and cost effectiveness:

Step 1: Concept Brief

In the concept brief stage, we listen to the client. Our goals here are to learn as much as we can about what the client wants. We are determining things like the product category, the target audience and sub-audiences, the desired claims to be made, dosage form, and budget limitations.

Step 2: Ingredient Surveying

This is where we really shine. With so many ingredient offerings out there, it is critical that formulators attend the trade shows, read the trade news, keep in touch with suppliers, watch the emerging science, and do everything they can to stay on top of what is hot and what has the scientific backing for claims. We like to pull together potential ingredients that are a balanced mix of hot studied and branded ingredients, classic well-studied ingredients, and some of those that might not have the strongest of science, but still may resonate in a formula because of trendiness or consumer expectations (e.g., raspberry ketones).

Step 3: Ingredient Screening

Once we have a pool of maybe 20 to 30 potential ingredients, we have to screen through them figure out which are most aligned with the goals established in Step 1. Reasons for elimination might be too high of cost for required dosage, low compatibility for the dosage form, not marketable enough, or perhaps just not right for the positioning. In most cases, 20 to 30 ingredients can be reduced to closer to 10.

Step 4: Concept Presentation

With 10 great ingredients, many different arrangements can be put together. Our usual approach, however, is to determine a few lead ingredients that we know can be dosed together in order to deliver the primary claims for the product. At least one of these we usually like to be something branded and/or novel. Two or three concepts are generally shown to the client for review. To present the concepts, we show the client Supplement Facts panels, along with bulleted lists of the anticipated structure/function claims that will be able to be made. At times, we can also at this point provide rough cost estimates for the concepts.

Step 5: Client Feedback

Rarely do the presented concepts immediately check all of the boxes for clients, but we usually arrive at the one or two concepts that are close. Here we listen again to the client to see what is working and what is not.

Step 6: Concept Refining

After we get the client feedback, we take the formula(s) back to the drawing board and make the refining adjustments needed to arrive at a final formula that addresses everything that came out of step 5. Here again we create a new Supplement Facts panel and bulleted set of anticipated claims.

Step 7: Concept Approval

We never want to create a custom formula that leaves the client unhappy. If we need to run through previous steps and go through many refinements, we will. However, the goal is to arrive at a concept approval stage. The client is content with everything presented to this point in the process.

Step 8: Purchasing Specifications

Having a custom formula selected is exciting for a client, but especially for those new to the supplement world, knowing how to make it a reality might be a little more daunting. We like to make things as easy as possible for our clients at this point. We create purchasing specifications that the client can provide to contract manufacturers (assuming the client isn’t going to be the manufacturer) to ensure that they are quoted for exactly the formulation needed.

For the new DSE client, we followed all of these eight steps to arrive at a custom formulation that the client loved. In this case, we started with about 20 ingredients, and narrowed them down to just two. Although a simple sounding formula, it included a very new and hot branded and studied ingredient, as well as another generic one with multiple clinical studies behind it. The ingredients delivered the desired claims perfectly, and the dosage form we came up with was something we have never done or even seen before. We are excited to share the details in a future post in this series.

If you have any questions about our custom formulation for dietary supplements services, please contact us to learn more.

Starting a Supplement Company – Part 1: Overview

Start Supplement Company

Recently, a new DSE client called up with a big, but typical consulting request. He was enthusiastic about a new project – ready to begin immediately. However, rather than having needs for just some of the typical items like label review, claims review, ingredient review, etc., the request this time was for everything, or at least virtually everything from product concept to product launch. This would be their first product for their new company.

If all of this weren’t enough, other than having a target market identified, the client also requested that the product concept we come up with be formulated with scientifically-studied ingredients with strong claims, contain at least one new and hot branded ingredient, have an eye-popping product name logo with out-of-the-box thinking design work, and if possible, be delivered in a form (e.g., not standard capsules or powder) rarely or never seen before. A very tall order.

In addition, the client of course wanted everything to be compliant for their new brand. Although he may not have known what exactly that would entail, we had to start thinking about label compliance, claims substantiation and submission to the FDA, sourcing cGMP-compliant manufacturing and conducting an audit, creating SOPs, lining up finished product testing, creating specifications for that, and more.

With a large task list, we began right away. Although many of the tasks were overlapping and varied in time to complete, in this series we will briefly describe how we took on this project, what was required, and what the outcomes were. The client requested that we not reveal too many details of the actual product prior to their launch, but we will be excited to show what we come up with in the end.

The following are some of the tasks we will cover in this series:

  • Determining market needs and desired product claims
  • Ingredient screening
  • Proposing multiple formulations to fit market needs and desired product claims, as well as budget
  • Requesting multiple quotes
  • Selecting a manufacturer and auditing
  • Creating product specifications
  • Logo and compliant label design
  • Structure/function claims drafting, substantiating, and submitting
  • Creating a set of SOPs
  • Creating advertising copy
  • Facilitating finished product testing
  • And likely more

We hope you will enjoy this series of articles. You will get a glimpse into how we assist clients, and maybe find something you can apply to your business.

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.

FDA Warning Letter Amended

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

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

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

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

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

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

Further, the Dietary Supplement Labeling Guide provides the following:

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

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

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

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

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

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.