Should You Trust AI Programs for Dietary Supplement Claims Compliance?
Over the years, we have been approached multiple times about artificial intelligence programs for reviewing and correcting dietary supplement copy for FDA compliance. We have been suggested by clients to create it. We have been asked by tech groups to co-create it. We have been pitched it by those that have attempted it. And while […]
FTC Sends Nearly 700 Letters to Brands!
On April 13th, nearly 700 companies selling dietary supplements and other health products received letters from the FTC, putting them on notice about claims being adequately substantiated and civil penalties that may occur if they are not. Did your brand make the list? Did your competitors’ brands make the list? Check here. If you’d like to […]
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 […]
FDA Confusing on Plant Parts
For years, one of the most common violations cited in FDA Warning Letters has involved missing plant part(s) declarations for botanical ingredients. Specifically, the regulations require that the part(s) of the plant (e.g., root, leaves, seeds, etc.) from which a botanical dietary ingredient is derived be declared in the Supplement Facts panel. A few compliant […]
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 […]
Label Review Tools Part 2
If you are a frequent reviewer of dietary supplement labels, you have probably found that your speed and efficiency increase when you have your “tools” readily accessible. All the way back in 2014, we published the Part 1 to this article, and are finally making good on the Part 2. The previously named tools included
Top Supplement Label Errors of 2020
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.
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 […]
How Much Does Dietary Supplement Label Review Cost?
By Curtis Walcker, M.S. February 22, 2018 Since 2013, we have set our fees based on what we feel is fair to the client. FDA label compliance review was actually the very first service we offered, and remains among the most popular. Our fee for label review has been a flat $499 per label, with […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Supplements Claimed to Treat 100+ Diseases
By Curtis Walcker, M.S. April 12, 2015 I 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 […]
First Seven FDA Warning Letters for Supplement Labels in 2015
By Curtis Walcker, M.S. March 29, 2015 Only 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 […]
2014 FDA Warning Letters Trends
By Curtis Walcker, M.S. January 26, 2015
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 […]
Does The Practice of Having a Weight Range of 95% – 105% Produce a Misbranded Product for Class I Nutrients?
Andy Swenson November 17, 2014 A 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 […]
Dietary Supplements: Intended for Ingestion
Guest post by Sarah Eliason October 19, 2014 If you label your product as a dietary supplement, but claim that it can be consumed in any way other than oral ingestion, you may be at risk for a Warning Letter. The Dietary Supplement Health and Education Act (DSHEA) defines a dietary supplement as a product […]
AERs: Insurance Implications
Guest post by Greg M. Doherty, CPCU, ARM August 27, 2014 An increase in adverse event reports raises product liability insurance disclosure requirements for supplement companies. It was recently reported that the number of government mandated adverse events reports (AERs) connected to dietary supplements has risen for six consecutive years. AERs reflect hospitalizations, life-threatening illnesses, […]
Label Review Tools Part I
By Curtis Walcker, M.S. August 10, 2014 If you are a frequent reviewer of dietary supplement labels, you have probably found that your speed and efficiency increase when you have your “tools” readily accessible. This month we have prepared a two-part series focusing on a selection of the important tools of our trade. If you […]
2013 FDA Warning Letters Summary
In 2013, the US Food and Drug Administration (FDA) issued 67 warning letters.