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Nutrition fact panels must be in a compliant format < Back Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts and eggs, which led to an anaphylactic death. 👉From warning letter. “On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with …. your firm recalled the cookies. The products contained peanuts and eggs but your printed label on the package did not contain an allergen statement or ingredient declaration for peanuts or eggs.” The warning letter goes on to state that there are missing and extra ingredients on the label, which shows that the company’s quality control procedures need a serious review. Disclosing major allergens is easy. Here are the two options. I always prefer the “Contains” option as it’s more apparent to the consumer. 👉The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or 👉The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)]. The Nutrition Facts Panel (NFP) is also not in the correct format. There are differences between a Supplement Fact Panel and an NFP. This FDA reference is pretty good. 👉From warning letter. “The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii). b. It lacks the declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii) c. It lacks the declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii)” Here are some examples of compliant NFPs . Read the warning letter here . DATE ORIGINALLY POSTED: 11/27/24 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!

< Back Interview Thursday Jul 15, 2021 Effective and practical marketing compliance Insider in the Afternoon We speak about structure-function claims, disease claims, marketing risk versus reward, and clever product names. Watch Previous Next

< Back Workshop Tuesday Apr 19, 2022 Marketing and Regulatory Compliance for 5th Year PharmD Students (2022) Massachusetts College of Pharmacy and Health Sciences This course reviews common product online and social media marketing pitfalls to avoid. We also discuss strategies to give graduates a leg up in nuanced and competitive world or product marketing Learn More Previous Next

Following specifications prevents greater issues < Back Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels. Greetings from Expo West! Today's Warning Letter Wednesday reviews the importance of making and following specifications. Sign up for my weekly blog here , which allows you to search 150+ previous posts. The batch of high-lead products has been in circulation since 2022 and was recently tested by the Connecticut Department of Consumer Protection's Food & Standards Division, which resulted in the recall. Thank you for finding this CDCP! Botanicals contain "naturally occurring" amounts of heavy metals, especially in the roots, which is why ingredients and finished product specifications are required to test these items. The American Herbal Products Association (AHPA) is a good resource for understanding specifications, but keep in mind that retailers and states like California (Prop 65) may have their own requirements. The most common warning letter violations involve specifications being incorrectly written or followed. Here are a couple of Warning Letter Wednesday posts about this. 🔹 1/22/25: Incomplete Batch Records & Ingredient Specifications 🔹 7/31/24: GMP Manufacturing Lessons As Warning Letter Wednesday readers know, I am not a company or product basher, which is why I typically don't call out company names in my newsletter. I, however, always provide a link to the warning letter or case so inquisitive subscribers can explore publicly available documents. When I look at the recall notice in more detail, I also see labeling issues such as the Statement of Identity "Herbal Supplement" or Dietary Supplement" missing from the Principal Display Panel (PDP). This is considered a major labeling violation, and it signals deeper compliance issues to anyone who is a label reader. The adage "Where there's smoke, there's fire" is often true with labeling violations. I then ran Apex Compliance® on the company's website and found several over-the-top disease claims. Since recalls often lead to warning letters, now is the time for this company to remove these risky marketing phrases. Also, to anyone who sells Shatavari, expect the FDA to ask about your specifications and testing during your next inspection. 👉 I write about the joys of being a label reader while traveling here (280k impressions). 👉 Read about the recall here . DATE ORIGINALLY POSTED: 3/5/25 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 Webinar Tuesday May 4, 2021 Preparing for Cannabinoid Regulations Asa's Regulatory Education Series Michael McGuffin and Johnel Lagabon join me for our next Regulatory Education Series event which will be primarily NDI focused. We discuss what hemp cannabinoid companies should be doing to prepare for FDA regulations. This will be reviewed from a legislative, scientific, and practical point of view. What if H.R. 841 passes? What would this require? What can companies do now to prepare? Overview of NDI regulations. Difference between NDI and GRAS? If a company starts with self GRAS, how close to NDI requirements does this get them? Specifics of NDI for raw material suppliers or finished products? Discuss strategy. Other thoughts on what companies can be doing to prepare? Learn More Previous Next

Asa and other industry leaders weighed in < Back Supplement weight management claims in the GLP-1 era Claudia Adrien Interview Asa and other industry leaders weighed in Earlier this year, California resident Christina Robins sued wellness brand Lemme Inc. accusing it of misleading marketing practices surrounding the company’s GLP-1 Daily supplement. Robins took action by seeking class-action status for customers who were also impacted by the practices. The class action complaint pointed to a lack of "clinical data that supports the notion that simply boosting the amount of naturally occurring GLP-1 in the body has sustained weight-loss effects." In the era of GLP-1 agonist medications, what can supplement companies say about products that claim to support the drugs? What are red flags when it comes to oversight? And where might gray areas exist? Read More Previous Next

In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends around homeopathic products, claims made in YouTube videos, delta-8 THC, and more. < Back Q3 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends around homeopathic products, claims made in YouTube videos, delta-8 THC, and more. Read More Previous Next

Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. < Back Compliance responsibilities when using a contract manufacturer Rachel Adams Press Mention Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. Read More Previous Next

Curated testimonials are marketing claims < Back Injectable CBD Warning Letter Curated testimonials are marketing claims Injectable CBD? The first CBD warning letter of the year is an odd one. The company was cited for selling injectable CBD products and making disease claims on its website and social media. Here are some key takeaways. 🔹Where is the commerce (sales) taking place? The company's website is designed for practitioners, and it looks like no actual commerce takes place on the website or social media. I even looked at archived website versions of the Wayback Machine. I didn't see anywhere to actually purchase the product unless I set up an appointment with a licensed therapy professional or provided professional credentials. Typically, these "gated" or "commerce-removed" websites do not attract FDA warning letter attention since no public commerce takes place. This type of situation is rare and is really interesting. 🔹Curated testimonials: The agencies are generally "hands off" with third-party, non-curated, non-compensated product reviews or testimonials. These become "marketing" when the company engages with them or curates them, such as adding them to a banner, product page, or social post. Also, FDA sometimes considers separate "testimonial" or "product review" pages as being curated, meaning they are fair game for enforcement. In this letter, the "testimonials" web page had many disease claims. This testimonial shows that making a "better than drugs" statement will increase the chance of a warning letter. 👉From warning letter. "I have now completed two PICO CBD infusions (each 14 days apart) and have had no need to take any Xanax. It's been years since I have been able to go 30+ days without an anti-anxiety pill." 🔹Products marketed as a dietary supplement. Even though the product image label does not appear to list a "supplement" statement of identity or fact panel, the FDA did some investigation work. 👉From warning letter. "You appear to be marketing your "Pico IV" as a dietary supplement. For example, marketing material found on your website states that "CBD, and other cannabinoids, are considered dietary supplements by the FDA . . . even if they're administered intravenously." 🔹Social media disease claims. FDA cited several disease claims in this letter. What's fascinating about this example is the company's use of "potentially." The softening words do not allow a company to make disease claims. 👉From warning letter. "CBD [p]otentially reduce anxiety and inflammation. CBG [c]an support bone health and neuroprotection" This letter came in a group of other injectable-related warning letters which shows that FDA wanted to make a statement about the dangers of IV therapeutics. Read the full letter here . DATE ORIGINALLY POSTED: 3/19/25 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 Jun 4, 2020 Cannabis, CBD, Regulations, & AHPA CannabisRadio.com Concierge For a Better Living Cannabis, CBD, Regulations, and AHPA are what Asa Waldstein, a veteran of the dietary supplement industry, sit down and talk about in today’s episode of Concierge For Better Living with Doc Rob. During these tough times, it gets harder and harder to find the light at the end of the tunnel. Asa helps do this by diving deep into the dietary faction of cannabis. He also explains how old practices such as canning, can and are making a comeback in today’s cannabis industry. Listen Previous Next

Guest article in Let's Talk Hemp < Back FTC’s Operation CBDeceit Brings Action Against CBD Companies Asa Waldstein Guest Article Guest article in Let's Talk Hemp Read More Previous Next

Marketing strategies should consider “reasonable consumer expectations” to avoid issues < Back GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues This is one of the cringiest Warning Letter Wednesday posts I've ever written. Wow! This company received a warning letter for making claims that it is better than Ozempic, has FDA approval, does not require a prescription, has no side effects, and is clinically proven in "clinical trials and was approved by the Food and Drug Administration last year." This is the first GLP-1-related "supplement" FDA warning letter. Interestingly, it came in a group of five letters; the other four were companies selling semaglutide (generic Ozempic) labeled as "RESEARCH USE ONLY," but FDA cites their secondary marketing claims as proof of the intended weight loss use. Good detective work FDA! This warning letter is a great study of how implied and express claims cross the compliance limits, such as with the before and after pictures, statements like "Only active GLP-1 is effective GLP-1," and "FDA approved" statements. Here is my opinion on some of the information I've gathered. It is unclear what the ingredients in the product are, but they are marketed as natural and side-effect-free. The product is not labeled as a supplement, but it lists "Clinically Proven" and "Metabolism boost drops for weight management" on the label. The before and after pictures are super cringy and likely violate FTC regulations against deceptive marketing. The product reviews feel doctored, and the entire vibe of the website seems like an AI-generated experiment. It gave me the heebie-jeebies, and I expect the FTC would have a field day with this site. There are other "supplements" for sale on the website, such as THC gummies and weight loss gummies, that are making claims related to anxiety reduction (thanks to Apex Compliance for helping me find these). And much more FDA also cites this company for making "FDA-approved" claims. As we know, supplements are FDA-regulated but not "approved." From warning letter. "webpage for ...includes the image of a blue circle with the claim, "FDA APPROVED" along with the statement,. . . was approved by the Food and Drug Administration last year." Implied GLP-1 statements are cited but they’re probably not the primary reason for this warning letter. From warning letter. “The Science of GLP-1 . . . The effectiveness of … lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period.” Bashing companies is not my style, as I believe in a "rising tide" and educational approach, as many companies who receive warning letters may not know any better, but this company's marketing feels calculated and intentional. Read the full warning letter here . DATE ORIGINALLY POSTED: 12/18/24 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!