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 read the press release, or see the template for the letters sent, check here and here.

Regardless of who made the list and received the letter, the entire dietary supplement industry should be hearing the message loud and clear. And that message is to make only substantiated claims in your advertising and have adequate substantiation on hand at the time you make claims. If you are unsure how to comply with that, the FTC published a new Health Products Compliance Guidance document this past December. Clearly, they want this Guidance taken seriously.

If you received the letter, you should act fast and get your claims and substantiation lined up, as you will likely be on the front lines for a wave of enforcement likely to be coming. If you did not receive a letter, you might be a bit more under the radar, but we would advise the same thing. 

One of the things we tell clients repeatedly is that compliance can be a huge advantage, and it seems like it becomes more and more of an advantage for smart brands year after year. The truth is, most of your competitors have labels with regulatory violations that they do not know about and do not care about, a large number of your competitors have their products made in facilities that claim “cGMP-compliant” and “GMP-Certified” that fall short of the actual regulations in countless ways – usually starting right at the point of receiving raw materials, too many of your competitors are making explicit disease claims that make it difficult and unfair for you to compete, and virtually none of your competitors have adequate substantiation on hand for the claims they make in their advertising.

Yes, we are a very regulated industry, but enforcement is beyond low. And as we’ve seen with our clients time and time again over the years, having labels, cGMPs, and claims buttoned up can be a major advantage in the face of things like Amazon suddenly requiring cGMP documentation, FDA inspections, NAD cracking down on certain areas, California Prop 65 complaints, and mass letters from the FTC. What can turn into a major disruption and distraction for some brands, can also be a minor bump and chance to grab market share for other that are better prepared.

Dietary Supplement Experts has the experience in creating strategy around avoiding regulatory disruptions and distractions. We can help clean up compliance issues long before they ever become issues. You can keep selling while your competitors respond to Warning Letters, meet with lawyers, turn off ad campaigns, conduct recalls, lose customers, and wish they did things correctly earlier on.

Need claims substantiation for your product and advertising?

Not far behind dietary supplement label compliance review, one of our most common services for brands is building claims substantiation files. Here are three great reasons to consider this service for your brand:

1) COMPLIANCE – We’ve honed a robust format over the last 10+ years that has been presented and has held up to virtually all types of substantiation inquiries that our clients have faced. Claims substantiation is not optional – it is a legal requirement for your company. 

2) COPY WRITING – One of the biggest and most common mistakes we see is when brands write copy and make claims based on what competitors say. Do not make them fly blind and fall into this lazy trap – and put your company at risk. Our substantiation files include a main document that outlines your ingredients and the numerous claims that can be considered, as well as files containing the studies that would support those claims. We often use these files for creative kick off calls with writers to ensure they know the products that they are selling. 

3) PRODUCT DEVELOPMENT – We can create substantiation files for a new product, for and existing product, or for a product needing reformulation. In any case, our main substantiation document can be instrumental in giving your team a quick and easy method for dialing in doses, forms, combinations, delivery methods, etc. to ensure your product has maximum claims, uses the correct forms of ingredients, isn’t over-formulated and unnecessarily increasing product costs, and is safe and effective in your target populations. 

If you are interested in claims substantiation files that serve your legal requirements, but also serve your product development, advertising claims and angles, and bottom line, let’s discuss and get you into our schedule. Turnaround times are generally three to four weeks depending on your product. We have generous multiple-product discounting as well. Contact us today at experts@dietarysupplementexperts.com.

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.