Changing RACCs and the Implications

By Elaina Paniagua
September 11, 2016

On 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

After 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).

Inspections

Because many of the WLs sent were for the non-dietary ingredient violations, and inspections for those products generally involved review of the labels for ingredients, inspection types categorized as ‘labels’ were significantly higher than other categories in 2015. This did not equate to a proportionally high number of WLs citing label violations.

Inspection types resulting in WLs expanded in 2015. Social media sites have been receiving more scrutiny. The FDA is also looking for claims on online retail sites where companies are marketing DSs, such as Etsy and Amazon.

Geographic Locations

Below are heat maps of the continental Unites States showing the prevalence of WLs received by DS companies by State, as well as which States they were sent from. In 2015, companies in Florida, California, and Utah received the most WLs. The FDA tended to send the most WLs out of the District Offices located in Maryland, California, and Colorado.

Violations

Disease claims were the most cited violation in WLs for 2015. Non-dietary ingredient adulteration violations were in a distant second place due to some crackdowns on particular ingredients. Violations in current Good Manufacturing Practices (cGMPs) and labels were cited in more than 20 WLs each, indicating continued challenges for companies in both areas.

Disease Claims

The FDA cited disease claims violations from a variety of places, demonstrating their increasing concern about what companies are saying and where they are saying it. Product names that were disease claims topped the list along with disease claims made on Facebook. New areas in 2015 include e-books, LinkedIn, and Tumblr.

Not much changed in 2015 from previous years in terms of the types of disease claims marketers are illegally using. The top 15 should be no surprise. Combinations of many of these showed up in several of the WLs. The FDA generally only cites disease claims violations in WLs that are clearly explicit.

cGMPs

Violations of every Subpart of the cGMP regulations were cited in the 2015 WLs. Production & process controls and quality control Subparts saw the most violations. Companies failing to have adequate master manufacturing records (MMRs) and batch production records (BPRs) continues to be a major problem.

Labels

Of the 80 DS WLs issued in 2015, nearly 30% of them cited violations for product labels. This number is likely deceivingly low because so many of the non-dietary ingredient WLs seemingly failed to also cite label violations for the offending products. All 23 WLs citing label violations highlighted errors within the information panels; only 13 involved errors within the principal display panels.

One of the biggest label violations of 2015 involved matching the label’s recommended usage of the product to the declared Serving Size. The majority of the top 10 violations were made within Supplement Facts panels. Failing to include proper contact information for the reporting of serious adverse events associated with product use is a prevalent problem among labels.

Note: All information in this article was derived in good faith and is believed to be accurate. Data was collected from all 2015 FDA Warning Letters issued to dietary supplement companies posted on the FDA’s website as of February 3, 2016.

Structure/Function Claims Basics

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

Communicating 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?

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.
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.
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

Many 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 (Updated October 29, 2017)
This month’s article highlights five mistakes in label compliance that we commonly see in our dietary supplement label reviews.

1. Copying label design from other dietary supplement labels

A tell-tale sign of label design plagiarism is when the label appears to be a hybrid of compliance and non-compliance. Sometimes this is in the form of a nutrition label that says “Supplement Facts” across the top, but then has the design elements for conventional foods. Other times, some label components are very compliant, while others indicate a clear lack of knowledge of the labeling regulations. No matter what the issues are, the bottom line is that copying someone else’s label to create your own is a very bad practice. You never know how well the other company understood the regulations, or to what level they complied with them. Your interpretation of their label as it applies to yours will probably even create further problems.

2. Continuing to make errors just because you always have

When your labels are up for reprinting, it is a great time to send them through the review process with someone knowledgeable about the regulations. If changes must be made for better compliance, do not resist. Just because errors have been made for long periods of time without detection, it does not mean that they are any more correct. If a claim is being made that should not be made, or a Serving Size has been wrongly declared, correct it as soon as possible. Marketing messages and formulations can be adjusted with some creativity. The labeling regulations are far less flexible.

3. Assuming that certain label violations are low risk

Making the assumption that certain aspects of label compliance are lower risk or lower priority than others can be a huge mistake. Many times in our label reviews, clients might not see the purpose of our requested changes, or opt not to make them with their own assessment that the requests are low risk. Our explanation is first the regulations that require the change, and second the fact that the FDA’s label inspections have been increasingly technical over the years, as evidenced by Warning Letters citing seemingly minor violations. Having a Warning Letter come up on the internet when people search for your company is not worth the risk of maintaining label problems for no good reason. Not to mention the growing number of clients we are getting that have their products detained at the borders because of very minor violations.

4. Using the wrong units of measure

This we see a lot. Sometimes it is because the company was not aware of the proper units of measure to use for declaring ingredient amounts; other times it is because they wanted things to appear better on their label. In most cases, when our review finds that something declared in mg, for example, needs to be declares in g, we are met with some reluctance. The company usually does not want to go from declaring 1,500 mg of an ingredient to 1.5 g, even though that is what the regulations might require. Like the mistake above, maintaining something like this might seem minor and low risk, but could find its way into a Warning Letter or cause a shipment to be detained at a border.

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

5. Making “zero claims”

“Zero claims” are essentially claims made in the Supplement Facts panel that show an ingredient is present at a value of zero (e.g., Total Fat 0 g). These find their way onto labels for many reasons. Sometimes it is label plagiarism, many times it is marketing, and other times companies feel it is required. On conventional food labels, there are requirements for making zero claims. However, on dietary supplement labels, you are not allowed. If you have zeros under your Amount Per Serving heading, they must be removed.

Hopefully none of these frightening mistakes are ones that you are currently making. If you are, it would be worth reviewing them at your next label printings or sooner. Keep in mind that these are just a slim fraction of what we see on a regular basis. If you have questions or need full label review, please contact us anytime.

Made in the USA, Except In California

By Curtis Walcker, M.S.
September 9, 2015
If 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?

The 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.

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
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?
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?
Does your label include nutrition information or recommendations for subpopulations such as infants, pregnant or nursing women, or children?
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

The 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

An 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.