5 Terrifying Label Mistakes

By Curtis Walcker, M.S.
October 25, 2015  (Updated October 29, 2017)
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.

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.

Made in the USA, Except In California

By Curtis Walcker, M.S.
September 9, 2015
Made in USAIf you are currently using “Made in USA” claims, either explicitly or by implication with the use of images such as the U.S. flag or map, it might be a good time to review them. Recently, a number of companies have been targeted in California-based lawsuits for non-compliance and potentially misleading consumers.

The FTC has a guide for complying with what is referred to as the “all or virtually all” standard. The standard basically requires that all or virtually all of the parts or processing that go into a product must be of U.S. origin – it should contain no or negligible foreign content.

When used properly, the FTC guidelines allow for unqualified and qualified Made in USA claims. An unqualified claim would be saying directly that a product was Made in USA or is of domestic origin, with no further context. A qualified claim would describe the extent, amount, or type of a product’s domestic or foreign content or processing to indicate that the product is not entirely of domestic origin. Examples of qualified claims might include:

  • “Made in the USA with U.S. and foreign parts.”
  • “Made in the USA with ingredients from around the world.”
  • “Encapsulated in the USA.”

Perhaps the reason for some companies’ troubles with the claims recently, particularly in California, is that the California Business and Professions Code §17533.7 is much more stringent on Made in USA claims. It reads:

“It is unlawful for any person, firm, corporation or association to sell or offer for sale in this State any merchandise on which merchandise or on its container there appears the words “Made in U.S.A.,” “Made in America,” “U.S.A.,” or similar words when the merchandise or any article, unit, or part thereof, has been entirely or substantially made, manufactured, or produced outside of the United States.”

You will notice that California does not have the same “all or virtually all” standard. Since many dietary supplements contain ingredients of foreign origin, qualified claims are commonly used per the FTC standard. If your dietary supplements are sold in the State of California, and you currently use any sort of Made in USA claims – explicit or qualified – a close read of the regulation above and review of your labels might be wise to determine you own level of compliance.

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

Dietary Supplement Shelf Life Data

By Andy Swenson
April 15, 2015

expiredAn observation commonly noted in FDA Warning Letters to dietary supplement companies is the use of a shelf life date, with an assumed lack of data which supports that date. At first glance this appears to be a legitimate requirement. However, when reviewing the Part 111 Final Rule and other statements made by the FDA, a conflict quickly arises.

In the 21 CFR Part 111 Final Rule (72 FR 34751), published on June 25, 2007 the FDA responds to comments about shelf life dates by saying…

…any expiration date that you place on a product label (including a “best if used by” date) should be supported by data. (34856)

A simple internet search using the key words “Food Expiration Date” on the FDA’s website brings up the following:

Did you know that a store can sell food past the expiration date?

With the exception of infant formula, the laws that the Food and Drug Administration (FDA) administers do not preclude the sale of food that is past the expiration date indicated on the label. FDA does not require food firms to place “expired by”, “use by” or “best before” dates on food products. This information is entirely at the discretion of the manufacturer.

And, from the Small Entity Compliance Guide, published in December, 2010:

Does the DS CGMP rule require me to establish an “expiration date” (or a “shelf date” or “best if used by” date)?
No. (72 FR 34752 at 34855)

It is important to recognize that neither shelf life dates for foods, nor data which supports a shelf life date is required. And, they are not mutually exclusive, i.e. you can have one without the other. This is evident for two reasons. Firstly, the Part 111 Final Rule and cGMPs define the word “Must” as a requirement. If data to support a shelf life date were required, “Must” (requirement) would be used instead of “Should” (which denotes a preference).

Secondly, the Part 111 cGMPs and FD&C Act do not explicitly state a company must have data which supports a product’s shelf life date. The only mention of shelf life dates is in reference to the length of time reserve samples must be held (111.83, 465 & 605). This is the reason shelf life date observations are always at the end of a warning letter and never included in the formal citations found in the body of the letter. The observation is an expectation which is different from an enforceable regulation.

Naturally, having a shelf life date supported by data is always preferred. However, companies are not required to meet FDA preferences, only the requirements stated in the Part 111 regulations and the distribution of safe product. If the FDA wants to require shelf life dates to be supported by data, then they must change the regulations.

Supplements Claimed to Treat 100+ Diseases

By Curtis Walcker, M.S.
April 12, 2015

DiseaseI am not sure how many times over the years I have heard dietary supplement industry problems explained away as rare situations involving “bad actors” or a “few bad apples”. Of course these expressions are coming from those within the industry. And although it might be easy to sort of mindlessly accept the notion that the vast majority of dietary supplement companies are in full compliance with the regulations, it may not be realistic. That is not to say all non-compliances exist intentionally, but the industry certainly has more bad apples than many of us care to admit.

One easy way to support this assertion is to look at the Warning Letters sent to dietary supplement companies. Looking at just the most prevalent violation type by number of Warning Letters issued, which is for products being claimed to treat or cure disease (unapproved new drugs), it does not take much to see a major problem. Of the 19 Letters issued to dietary supplement companies so far in 2015 – which is a lot at this point – 18 were going too far with their claims.

The FDA must be credited with keeping on top of the clever tactics being used for product marketing, especially on the internet. Here are the number of companies cited for disease claims violations in the various areas that the FDA is looking:

Website – 16
Brochures / flyers – 6
Product names – 3 (This one should be cited far more often)
Testimonials – 3
Facebook – 3
Meta tags – 2
LinkedIn – 1 (Take note, this is a new area being cited)
Books / e-books – 1

Now if you were not taken aback by 18 companies marketing their dietary supplements in ways that cause them to be viewed by the FDA as unapproved new drugs, and seeing the number of places disease claims are being made, then have a look at this. Below is a list of the diseases supposedly being treated by these 18 companies. It should be noted that this list could actually be expanded, but for practical purposes, some diseases have been generalized and combined.

ADD/ADHD, AIDS / HIV, Allergies, Alzheimer’s disease / dementia, Anemia, Angina, Anorexia nervosa, Antimicrobial, Antipsychotic, Anxiety / nervousness, Arrhythmias, Arthritis, Asthma, Atherosclerosis, Autoimmune, Blood pressure, Brain damage, Cancer, Celiac disease, Cholesterol, Chronic fatigue syndrome, Circulation, Clotting, Cold / flu / other URI, Colitis / UC / IBD, Combats aging (implying disease), Convulsions, Cough, Crohn’s disease, Cuts / Wounds / Burns, Diabetes, Diverticulitis, Down syndrome, Dysentery, Dystonia, Earache / ear infection, Effects of alcohol, Encephalopathy, Epilepsy, Erectile dysfunction, Eye pain, Fever, Fibromyalgia, Gallstones, GERD / heartburn, Gout, H1N1, Hansen’s disease, Hashimoto’s disease, Headache / migraine, Heart diseases (other not listed), Hodgkin’s lymphoma, Hypoglycemia, Irritable bowel syndrome, Immune, Inflammation, Kidney diseases, Leprosy, Liver diseases, Lou Gehrig’s disease, Lung diseases, Lupus, Lyme disease, Malaria, Menstrual problems, Multiple sclerosis, Muscle spasms / cramps, Neuralgia /neuropathy, Osteoporosis, Pain, Parasites, Parkinson’s disease, Prostate diseases, Rheumatic fever, Sarcoidosis, Schizophrenia, Seizures, Sickle cell, Skin diseases, Sexually transmitted diseases, Sterility / Fertility, Strep throat / sore throat, Stroke, Swelling, Thalassemia, Tinnitus, Tissue repair / wound healing, Tooth disease / oral health, Tuberculosis, Ulcers, Urinary tract diseases, Vision diseases, and Wilson’s disease.

If you wondered which of these diseases companies were claiming to be able to treat with their products most often, here is the breakdown by number of companies:

Inflammation – 8
Cancer – 8
Arthritis – 7
Diabetes – 6
Blood pressure – 6
Pain – 5
Cholesterol – 5
Antimicrobial – 5
Asthma – 4

Since it is generally a bad practice to point out problems without bringing some solutions, here are three quick tips you can use right now to begin cleaning up your marketing claims and hopefully avoid an FDA Warning Letter for them.

  1. Remove all explicit claims. The FDA most often points out explicit disease claims, rather than implied disease claims.
  2. If you are marketing a product in one of the nine categories listed above (cancer, inflammation, pain, etc.), make those products your priority for cleaning up claims.
  3. Learn the codified definition of disease, as well as the criteria for structure/function claims, and refer to both frequently.

First Seven FDA Warning Letters for Supplement Labels in 2015

By Curtis Walcker, M.S.
March 29, 2015

fda-warningOnly three months into 2015, the FDA has already issued 19 Warning Letters to dietary supplement companies, seven of which cited product label violations. This is the same number of Warning Letters citing cGMP violations. Five companies were cited for both label and cGMP problems. It is not only clear that the FDA is gathering and reviewing labels during facility inspections, but also that companies continue to struggle to label their products compliantly.

In the seven Warning Letters citing label violations, the FDA managed to find problems with every mandatory label component:

Statement of identity: One company did not identify their product with the term “dietary supplement” as part of a statement of identity.

Net quantity of contents statement: One company neglected to include one. Another stated their net quantity of contents in U.S. Customary terms only.

Supplement Facts panel (SFP): All seven companies had issues with their SFPs. These violations included: no SFP, missing or incorrect Serving Sizes and Servings Per Container, zero amount claims, missing dietary ingredients, missing plant parts for botanical ingredients, and declaring (b)(2)-dietary ingredients out of order.

Ingredient statement: One company was missing ingredients in their statement.

Name and place of business: One company failed to include their name and/or place of business on their label as required.

Other: Two companies neglected to include a domestic address and/or domestic telephone number through which serious adverse events associated with the products could be reported. One company was using two languages on their label, but did not repeat all of the required label information in both languages.

In all of 2013 and 2014, the two most common label violations cited in Warning Letters involved inadequate statements of identity and missing plant parts for botanical ingredients. In 2015, the most common one (three of seven companies had this problem) is having the wrong Serving Size in the SFP. Take notice and review this aspect of your own labels. Here is what you need to know:

  • One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or in the absence of recommendations, one unit (e.g., tablet, capsule, packet, teaspoonful, etc).
  • If you recommend one capsule with a meal up to three times per day, your Serving Size is one capsule.
  • If you recommend one to three capsules per day with a meal, your Serving Size is three capsules.
2014 FDA Warning Letters Summary

2014 FDA Warning Letters Infographic

By Curtis Walcker, M.S.
January 20, 2015

In 2014, 31 of 71 (44%) of FDA Warning Letters sent to dietary supplement companies cited label violations. Compared to 2013, the number of label Warning Letters, as well as the percent were virtually the same (30 letters and 45%, respectively). The Supplement Facts panel, ingredient statement, and statement of identity were the label components holding the most violations. Specifically, the most cited violations (by number of Warning Letters) were improper statements of identity, failing to include the plant parts from which botanical ingredients were derived, and failing to declare ingredients in the ingredient statements, such as the ingredients of capsules.

2014 FDA Warning Letters Summary

Share this Image On Your Site

Does The Practice of Having a Weight Range of 95% – 105% Produce a Misbranded Product for Class I Nutrients?

Andy Swenson
November 17, 2014

weight-varianceA common practice within the Dietary Supplement industry is to manufacture a solid dose batch using a weight range of ± X%, where X equals the percentage over/under a Target weight (100%) and Target equals the minimum weight at which all of the label claim is delivered plus any amount added for shelf life overages. Some companies claim this practice yields misbranded product per the labeling regulations found in 21 CFR Part 101.9 because, statistically speaking, approximately half of the batch will be under 100% and all product which contain Class I nutrients must be at 100% of label claim. While this statement is true (half the batch would fall under 100%) it does not necessarily make the batch misbranded. This review will (i) provide a clear understanding of the sampling and testing methods used to verify label claims, (ii) provide a clear under-standing of what constitutes a misbranded product, and (iii) determine if using a weight range of 95% – 105% yields product that is suitable for distribution (not misbranded).

GENERAL PRACTICE

Dietary supplement solid dosage forms, such as capsules, tablets & softgels, but hereafter referred to only as capsules, are formulated to meet specific nutrient claims stated on the product label. This is done by calculating the quantity of a material required to meet the label claim based on its purity. Then, depending on the number of capsules per serving, i.e. 3 capsules per serving, the amount is converted into the weight of the material required for a single capsule. The resulting capsule weight is referred to as “Target” and represents the exact weight a single capsule must attain to deliver 100% of the nutrients claimed on the label when taken as directed (capsules/serving size).

Because of equipment limitations it is impossible to produce a batch in which each capsule weight is at exactly Target. To compensate for this inherent variation and still ensure the nutrient label claims are delivered, individual capsule weights are allowed to fluctuate within a specified range with the intent of the average capsule weight of the batch to be at or above Target. While this weight range varies between companies it is typically 95%―105% relative to Target (100%).

The conundrum lies in statistical population distribution. Theoretically, if a batch were produced in this manner, half of the capsules would be over Target and half of the capsules would be under Target, i.e. servings would not deliver 100% of the nutrient label claims. Because the labeling regulations require Class I nutrients to be at 100% of the stated label value this approach would produce a batch which is misbranded.

SAMPLING & TESTING

In order to determine if a product is misbranded the compliance requirements must first be understood. Because dietary supplements are categorized as Food, the applicable labeling regulations are found in Part 101―Food Labeling, April 1, 2012 Revision, Section (g).

21CFR PART 101.9 – Food Labeling, (g)(1) & (2)

Paragraphs (g)(1) through (2) describe the sampling plan and composite sample preparation used to verify the nutrient content of a product when compared to its label claim.

The sampling plan consists of obtaining 12 primary containers/units (bottles) at random throughout a batch. Then, a subsample (consumer unit) is taken from each container and combined to form a composite sample. Per the law of averages this represents the entire batch.

21CFR PART 101.9 – Food Labeling, (g)(7)

Once the sampling and testing of a batch is determined acceptance criteria is defined as…

“Compliance of the composite is based on the metric measure specified in the label statement of serving size.”

Based on this and relative to a capsule, the term “Consumer Units” [(g)(2)] is the total number of capsules in a serving. If a label instructs a person to consume 2 capsules, 3 times daily for a total of 6 capsules per day, only 2 capsules (a consumer unit) from each container would be used to make the composite sample. If the directions instructed a person to consume 1 capsule per day then only 1 capsule (a consumer unit) from each container would be used to make the composite sample.

A composite sample comprised of 12 servings is tested to determine the average nutrient content of the batch.

MISBRANDED PRODUCT REQUIREMENTS
21CFR PART 101.9 – Food Labeling (g)(3)

To determine if a batch is misbranded (unsuitable for distribution), the regulations have established the minimum nutrient content, based on type, which must be present in the composite sample, which represents the batch.

Sec.(g)(3) defines two classes of nutrients (ingredient/contents declared in the supplement facts panel):

  • Class I. Added nutrients in fortified or fabricated foods.
  • Class II. Naturally occurring (indigenous) nutrients.

21CFR PART 101.9 – Food Labeling (g)(4)

After segregating the Nutrients, the regulation specifies per Class the amount which must be present in the product when compared to the label.

The regulation states:
A food with a label declaration of a vitamin, mineral, etc. is deemed to be misbranded under section 403(a) of the FD&C Act unless it meets the following requirements:

  • Class I: The nutrient content of the composite is at least equal to the value for that nutrient declared on the label.
  • Class II: The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label.
  • The nutrient content does not fall below the stated label claim by a factor less than the variability generally recognized for the analytical method.

(Methods always have inherent variability, which is typically expressed as a percentage (%). It is [generally] established during method validation/verification and varies per method, analyte and product matrix. This variance is usually accounted for when calculating results or when comparing results to the acceptance criteria.)

When compared to the label values the average content of the composite sample must be at least:

  • 100% – Class I / Added Nutrients, or
  • 80% – Class II / Naturally Occurring, and
  • Within (scientifically established) method variability.

21CFR PART 101.9 – Food Labeling (g)(6)

The requirements allow for some content variance when compared to the label if the product was manufactured using current good manufacturing practices (cGMPs).

The regulation states:
“Reasonable excesses of a…

  • vitamin,
  • mineral,
  • protein,
  • total carbohydrate,
  • dietary fiber,
  • other carbohydrate,
  • polyunsaturated or monosaturated fat, or
  • potassium

…over labeled amounts are acceptable within current good manufacturing practice.”

CONCLUSION

To determine if a product is misbranded the FDA makes a composite sample by taking a serving from twelve bottles. This sample, which represents the batch, is based on the law of averages which simply states that a small population represents the larger population. Class I nutrients must be ≥100% of the stated label value and those nutrients specified above may be greater than the stated label value within a reasonable amou.

Because misbranding is determined through composite sampling and averages, statistically speaking the sample should be comprised of an equal number of both over and under-weight capsules. Therefore, if a weight range of 95% – 105% is used it is critical that 1) The average weight of a batch equals Target or greater, 2) Multiple samples are taken throughout the batch, and 3) A composite sample is made from those representative samples. If these three requirements can be met then, statistically speaking, the process should produce a batch suitable for distribution wherein all Class I nutrients are ≥100%