Tag Archives: FDA

Final Nail in the CBD Coffin?!

Recently, the FDA gave a conclusion to the CBD story. In short, they reconfirmed that CBD is not allowed in dietary supplements or conventional foods, and confirmed that they do not intend to pursue rulemaking that would allow it. 

Will this “news” do anything to change the market flooded with these illegal products? Unlikely. There is a segment of the industry that has so far largely ignored the red flags such as the droves of FDA Warning Letters (lots of them), the scant science to give any credence to the claims (“but Big Brand X says it’s good for insomnia, pain, depression, COVID-19, etc.” is not substantiation), the fact that most legitimate manufacturers won’t touch CBD, the lack of banks to process the sales, the lack of networks that will run ads, the wacky labeling rules – aka violations (somehow isolated CBD = hemp extract), and so on. Many convinced that the all but irrelevant 2018 Farm Bill legalized CBD in supplements and foods, and so felt justified to join the mob of CBD sellers. 

Will FDA enforcement change? Time will tell. Probably just more of the same. Expect to see continued Warning Letters for products making disease claims, with reminders that CBD isn’t a legal dietary ingredient. 

DSE has dozens of clients working with CBD. Our advice generally has centered around risk mitigation – not making disease claims, not making unsubstantiated claims, labeling the products compliantly as possible (as if CBD were legal), and keeping a close eye on product quality. Risk of selling CBD products might be low, reward might be high, but make no mistake – CBD in supplements has not been legal, is not legal, and will not become legal according to the FDA. 

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.

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:

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.

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.

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.

New Regulations for Dietary Supplement Labels

By Curtis Walcker, M.S.
June 24, 2015

Will Your Supplement Facts Panels Require Changes Soon?

New RegulationsThe final rules resulting from the FDA proposed changes to nutrition labels, including the Supplement Facts panel, will become effective 60 days after publication in the Federal Register. January 1, 2018 will be the uniform compliance date, provided that the regulations are issued as expected in 2016.

Although this timeline sounds long, it really is not. Labels will need to be evaluated for needing changes. Current labels will need to be depleted. Changed labels will need new design work and reprinting. Although the changes that will occur can only be speculated on right now based on the proposals, doing an early self-audit can give you a rough estimate of how extensive your changes may be.

Here are five questions you should be asking right now. If you can answer “yes” to one or more for a label, it is possible that it will require changes.

  1. Do you currently declare any of the following?
    • Calories (significant dietary amount)
    • Calories from Fat
    • Total Carbohydrate
    • Other Carbohydrate
    • Sodium
    • Potassium
    • Dietary Fiber
    • Vitamin A
    • Vitamin C
    • Calcium
    • Vitamin D
    • Vitamin E
    • Vitamin K
    • Thiamin
    • Riboflavin
    • Niacin
    • Vitamin B6
    • Folic acid, folate, or folacin
    • Vitamin B12
    • Biotin
    • Pantothenic acid
    • Phosphorus
    • Magnesium
    • Zinc
    • Selenium
    • Copper
    • Manganese
    • Chromium
    • Molybdenum
    • Chloride
    • Choline
  2. Does your product contain sugars that are either added as ingredients during processing or are finished products; this includes sugars (free, mono-, and disaccharides, syrups, naturally-occurring and concentrated sugars isolated from a whole food (e.g., fruit juice concentrates)), or other caloric sweeteners?
  3. Does your label currently not declare vitamin D or potassium, but contain more than 0.4 mcg (16 IU) vitamin D or 5 mg potassium per serving?
  4. Does your label include nutrition information or recommendations for subpopulations such as infants, pregnant or nursing women, or children?
  5. Are you using nutrient content claims or health claims?

Answering “yes” to question #1 will probably result in the most label changes. There is also a possibility that the footnotes and/or formatting could see revisions that could produce much more sweeping changes.

NYAG and FDA Agree

By Curtis Walcker, M.S.
April 21, 2015

LawThe FDA posted a new Warning Letter on their site today. The recipient was Yummy Earth Inc., located in New Jersey. It was instantly interesting because this is the second week in a row that the FDA has cited violations for misusing “healthy” nutrient content claims. This new beginning trend started with last week’s letter to KIND, LLC, which has received a considerable amount of attention in the press.

However, there was another interesting violation cited in the Yummy Earth Warning Letter. The company was making an implied nutrient content claim for the amount of vitamin C contained in their YumEarth Organics organic pops. The FDA went on to explain that the ascorbic acid added to their product was not consistent with the fortification policy in 21 CFR 140.20, which states that the FDA does not consider the fortification of snack foods such as candies appropriate.

In another recent warning letter of sorts, the New York Attorney General’s Office sent a letter to Snap Infusion LLC, in Massachusetts, who markets a vitamin-infused snack called SmartCandy. Although NYAG’s office had multiple serious concerns about this product, 21 CFR 140.20 was again cited. Nutrient content claims were also being made here for several vitamins.

To read the Warning Letter to Yummy Earth Inc:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442130.htm

To read the letter from the NYAG’s Office to Snap Infusion LLC:
https://www.truthinadvertising.org/wp-content/uploads/2015/04/smartcandy-letter.pdf

To read the fortification policy per 21 CFR 140.20:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=104.20