Search Results

Ensure vendors are properly qualified < Back 7 Homeopathic Eye Product Warning Letters Ensure vendors are properly qualified Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics. Most of these companies were selling ophthalmic homeopathic products with some disease claims. I assume that if there were no GMP concerns, the products were not for use in the eyes, the target audience was adults, and there were no serious disease claims, many of these companies would not have received warning letters. FDA probably cited this group of products because they are (ophthalmic) added to the eyes, which may potentially endanger eye health. There are allowable OTC monographs for these types of products, but it seems the products were homeopathics, not labeled as OTCs (Drug Facts Panel), or in at least one instance, the product was labeled as an OTC but was not submitted to the required National Drug Code Registry . Products added to the eyes can be dangerous, and eye two lubricant products contain NAC, which I don’t think is approved for ophthalmic delivery. When I was a supplement manufacturer, I always said NO to making these types of products. From warning letter, “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.” Here are some other highlights: 🔷 This company was cited for making disease claims in testimonials. It is worth noting that testimonials were showcased and promoted in a banner. If the testimonials were part of a 3rd party review widget, such as those uncurated reviews that come in through a service like Trustpilot, they probably would not have been cited. 🔷 My “day job” is running a regulatory consulting company. Contact me to discuss reviews, labels, or online marketing compliance questions. This helps support my WLW writing passion (smiles). 🔷 Normally, there has to be commerce for a company to receive a warning letter. This company does not appear to conduct commerce on its website and only offers a practitioner login option. The company was selling ophthalmic products with disease claims, which led to the warning letter even though there does not seem to be public commerce on the site. This is VERY INTERESTING and should be a wake-up to companies using this strategy to push the compliance boundaries. 🔷 This well-known homeopathic company was cited for not only making ophthalmic homeopathic products and disease claims, but this warning letter also includes numerous GMP violations. Products from this company were placed on import alert, which speaks to the severity of the alleged GMP issues. I assume that FDA “followed the breadcrumbs” for other products made at this facility, which led to the Walgreens and CVS warning letters. This highlights the need for supplier qualification, something consultant Nate Call is an expert at. 🔷 A four-year-old social post was cited, which is another reminder to remove language from all social media, no matter how old. 🔷 From warning letter. “February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Learn from other’s mistakes < Back Arthritis Claims Enforcement Learn from other’s mistakes Since the beginning of 2023, 11 warning letters have been issued for arthritis-related supplements and topical product claims. Here, I explore these warning letters, look at common trends, and share key takeaways. Higher-risk disease claims : I have always wondered if making arthritis claims alone is enough to trigger a warning letter. The answer is surprisingly “not really.” All warning letters since the beginning of 2023 have included high-risk words like cancer, depression, and fibromyalgia, except one. This warning letter accompanied GMP citations and included arthritis claims that were part of an out-of-compliance OTC drug that did not follow the official monograph. Social media and YouTube : 45% (5 out of 11) mention claims on social media and YouTube. This is not a surprising number, and it shows FDA’s continued focus on social media marketing claims. Some of the cited social posts were a couple of years old, which is a reminder to ensure even those old posts are “clean” of disease claims. Are you interested in finding the high-risk statements on your website, videos, and content before publishing? My software product, Apex Compliance, can help you identify and replace these high-risk phrases before they lead to warning letters and lawsuits. Our AI has been custom-trained on compliance principles, including warning letters, and it helps you understand what compliant language looks like. Learn more and set up a free demo here . Blogs : 18% include claims made in blogs. I’ve written a lot of this before, such as in this post . GMP Inspections Lead to Marketing Review : 27% of letters started with a GMP inspection, which led to a marketing review. I write more about this here . Drug-spiked ingredients were mentioned in 18% of these letters . The moral of the story is to keep disease words like arthritis out of marketing, and they will signal to authorities to look deeper for other high-risk marketing phrases. Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Discussing ingredient benefits is marketing < Back Website “About Us” Claims Cited in Warning Letter Discussing ingredient benefits is marketing This warning letter cites claims made in the “About Us” section of the company’s website. Usually, when “About Us” claims are mentioned in warning letters, there is some hyperlinking to a shopping cart, but this letter mentions CBD and high-risk disease words such as Dravet Syndrome without any clear linking. The lesson here is simply talking about an ingredient can lead to a warning letter if that ingredient is sold on the website. From warning letter. “On your “About Us” webpage…CBD is FDA approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex.” This is the 34th CBD-related warning letter this year, up from just seven in 2021. This year certainly has been the year of the CBD warning letter, and I expect many more in 2023, including a crackdown on delta-8 and other isomer products. This company cited in this letter also sells fruits, such as mango and pineapple, that were apparently sprayed with CBD. FDA has been cracking down on CBD in food due to being favorable to children and the possibility of creating a safety concern. Read more about this here . This CBD fruit citation is another example that the days of “putting CBD in everything" are gone. Hashtags also play a prominent role in this warning letter. One post lists # anxiety and # depression. Over 30% of this year’s CBD warning letters mention the one-two punch of anxiety and depression. This post includes these two words together in hashtags is an excellent example of what not to do. From warning letter. “…promising results regarding #cannibidiols [sic] potential to assist with cognitive illnesses, including #anxiety and #depression.” Read the full warning letter . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Virtual Fireside Chat Friday Jun 16, 2023 Substantiation Dossiers: Building Trust in Label Claims for Retailers, Influencers, and Consumers Radicle Science June 16, 2023 (10:00 am PT / 1:00 pm ET) The dietary supplement industry has no shortage of attention lately when it comes to the Federal Trade Commission and the recent notices of penalty offenses on label claims. Brands are reaching for substantiation dossiers as a means to provide their retailer partners, influencers, and customers assurance that their label claims are factually accurate. Join Radicle Perspectives with Asa Waldstein , Principal of Supplement Advisory Group , as we discuss how to mitigate label claim risk, the impact recent headlines have had on dietary supplement consumers, and what Asa sees is next when it comes to the FTC drama. Key Topics: Understanding label claim risks in the dietary supplement industry Strategies to mitigate label claim risk through substantiation dossiers Insights into the future of FTC regulations and its implications for the industry Watch On Demand Previous Next

< Back In-Person, Panel Discussion Thursday Jan 23, 2025 Our Commitment to Product Integrity Organic & Natural Health Association Fort Lauderdale, FL 12:15 – 1:30 pm Our Commitment to Product Integrity Amy Summers Founder & President Pitch Publicity & INICIVOX- Moderator Deleo de Leonardis, CEO Co- Founder, Purity IQ Erin Taraborrelli, Program Manager, Labeling & Training Services, SGS nutrasource Ray Martinez, President, Florida Supplement Sandra Baek Lee , CEO, NJ Labs Asa Waldstein, Founder and Principal, Apex Compliance Learn More Previous Next

Well intentioned marketing claims can turn products into high-risk regulatory categories < Back Goat Milk Company Infant Formula Claims Well intentioned marketing claims can turn products into high-risk regulatory categories This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing statements can cross the line into a risky regulatory category. Let’s explore what went wrong. FDA looked at this company’s website and social media and determined their Goat Milk Formula Recipe Kit met the definition of infant formula because it was “purported to be or was represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Essentially, this means the company was promoting their product as infant formula. Here are some of FDA’s warning letter references. "We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.” Your February 12, 2024 (Facebook) post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .” I ran Apex Compliance on their website and found A LOT of very high-risk marketing claims, and I suggest this company look at conducting a compliance audit. Apex Compliance was developed for this type of situation, sifting through large amounts of information and providing a line-by-line playbook showing where risky phrases occur, their risk rating, and some possible lower-risk alternatives. Learn more here . To give the company credit, they seemed to go above and beyond to correct the matter once FDA brought this to their attention. It seems that even though they worked diligently to correct their mistake, FDA issued the warning letter to “ensure the violation does not recur.” Infants are classified as a “vulnerable population,” and this warning letter language demonstrates how seriously FDA takes the infant formula category. From warning letter. “We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit ... We are aware that you contacted all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.” Read the full warning letter here . DATE ORIGINALLY POSTED: 10/9/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

There are no FDA approved supplement facilities or supplement products < Back Supplement company’s brochures and online marketing lead to a warning letter There are no FDA approved supplement facilities or supplement products The FDA inspected a facility, then six months later they reviewed the company website. This is a continuing trend and a reminder to screen for disease words online, especially after a GMP inspection. Here the FDA refers to a product brochure as labeling. This is an important reminder that all marketing is an extension of the label. Here is a video about this. From warning letter: “On your product labeling (brochure) for “Kidz DHA,” which directs consumers to your website …. where the product is available for purchase: “DHA supplements are purported to treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).” Several other disease words are mentioned in this letter, such as anti-bacterial and anti-inflammatory. As a rule, words containing “anti” should be avoided. The one exception here is antioxidant. Also interesting in this letter is the mention by FDA that they do not approve facilities or supplement products. If a company claims to have FDA approval of their supplements, this is a marker they do not understand the basics of dietary supplement regulations. From warning letter: "We note that your website includes the statement that …. are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities. Read full warning letter here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Asa and other industry leaders weigh in < Back Regulators mostly silent on GLP-1 supplement claims Rachel French Interview Asa and other industry leaders weigh in The number of dietary supplement brands that make GLP-1-related claims is spiking. Yet, the emerging category of supplements has been largely met with silence from regulators, creating ambiguity for brands. Ozempic and similar drugs, classified as GLP-1 (glucagon-like peptide-1) agonists, were initially designed for the treatment of type 2 diabetes, but now are commonly used for weight loss. The drugs have seen immense popularity in recent years. One study published in the Annals of Internal Medicine identified a 700% increase in prescriptions for GLP-1 drugs in patients with overweight or obesity diagnoses over a four-year period. The study — which tapped 45 million de-identified medical records — found about 21,000 patients in the U.S. were using GLP-1 drugs to treat overweight or obesity in 2019, compared to 174,000 in 2023. Read More Previous Next

Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. < Back Regulatory compliance software helps supplement, nutrition, functional food, and cannabis brands vet their marketing claims Jennifer Grebow Interview Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. Read More Previous Next

< Back Presentation, Online Friday Nov 18, 2022 Naturally Informed: Living Longer, Stronger & Healthier Virtual Conference Registration Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in emerging categories such as brain health; bone, muscle, and joint health; libido; immunity; heart health; eye health; and more! On Demand Access Previous Next

Product reviews must be honest and truthful < Back Online company fined $4.2M for blocking negative product reviews Product reviews must be honest and truthful #WarningLetterWednesday Online company fined $4.2 million for blocking negative product reviews. The FTC alleges the company blocked product reviews with less than four stars. This is considered deceptive marketing and clearly warns companies that product reviews should be accurate. Here is what we can learn. 🔷Best practices for soliciting and posting reviews. From FTC letter ➡️Examples may include asking for reviews only from those likely to leave positive ones, preventing or discouraging submission of negative reviews, subjecting negative reviews to greater scrutiny, refusing to publish negative reviews, or otherwise not treating positive and negative reviews equally. 🔷Here are some FTC rules for possible exceptions to the "post all" rule. From FTC press release➡️(the company) must post on its website all customer reviews of products currently being sold—with the exception of reviews that contain obscene, sexually explicit, racist, or unlawful content and reviews that are unrelated to the product or customer services like shipping or returns. Here is a video about product reviews . Read the FTC press release . This is a different Warning Letter Wednesday because it is an FTC action (not FDA), and it involves a fine (not a warning letter) and doesn't include a supplement company. This is a good reminder that we can learn from other agency actions such as this one. 👉Join my Warning Letter Wednesday group here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Interview Thursday Mar 25, 2021 Herbalism, Compliance, & GMP's The Natural Nurse I speak with The Natural Nurse about herbalism, GMP's, and marketing compliance Listen Previous Next