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NAD challenge cases explored < Back Fruit Snack Wars NAD challenge cases explored The fruit snack wars are on! A few months ago, I wrote about General Mills challenging television commercials by Welch's Fruit Snacks (PIM's). In the commercials, chef Gordon Ramsay throws away "Fruit Flavored Snacks" by tossing them out of a window. That post includes information on "ash canning," an advertising term that describes the practice of portraying competing products as so inferior that they might as well be discarded like ashes. Read that post here . In this case, Welch's Fruit Snacks (PIM's), who was previously on the defense, challenged several claims made by the Mott's brand of General Mills. This shows that bringing NAD cases can have the added ramification of reciprocal action. 👉From NAD. Although these seem minor, they will likely lead to plaintiff lawsuits and demand letters, which are the biggest"impacts" of NAD decisions. "NAD found that General Mills failed to support these implied claims through challenged social media posts and by reviews reposted by General Mills, including: 🔹"These are great. Way [sic] to get my kids to eat fruits and vegetables. They have [had] a package each night after dinner for years and years." 🔹"My kids love eating these and I love the fact that it's made with real fruits and vegetables and no artificial colors. It helps with trying to show them how to eat mindfully and healthy." You may be asking yourself what the big deal is with fruit snacks. I looked this up. Apparently, this is a $4 billion industry in the US. Also, as a complete aside, every time I hear the name Mott's, I think about this 1987 commercial . Read the NAD case here . DATE ORIGINALLY POSTED: 12/4/24 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 Presentation, Online Tuesday Sep 20, 2022 Naturally Informed: Stress & Mental Wellness: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Regulatory Snapshot: Asa provides a review of enforcement trends, risks, and best practices for manufacturers and marketers in the stress and mental wellness space. Watch Now Previous Next

Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims < Back Compliance in the Digital Age: Navigating Enforcement, Marketing Risks, and the Rise of AI | State of the Supplement Industry Asa Waldstein Guest Article Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims Although the pace of FDA warning letters to dietary supplement companies appears to have slowed over the past 12 months, several important enforcement themes continue. GMP compliance remains a central focus, particularly regarding incomplete identity and finished product composition testing. The FDA’s long-standing mantra still applies: If it’s not written down, it didn’t happen. Read More Previous Next

< Back Panel Discussion, Workshop Monday Oct 28, 2024 Education session – Ingredient claims and legal flames: An interactive workshop to dodge regulatory heat SupplySide West Las Vegas, NV Noncompliant dietary supplement ingredient claims can be one of the reasons the Food and Drug Administration comes knocking. In this education session and interactive workshop, experts will dissect the U.S. regulations, laws and guidance that govern ingredient claims, as well as applicable court cases. The audience will apply these learnings in live polling, and then discuss and debate the results. If you’re a professional in marketing, science or regulatory affairs, don’t miss this practical, hands-on workshop. Katie Bond of Keller and Heckman LLP Stephanie-Anne Girard of SGS Nutrasource Corey Hilmas of KGK Science Josh Long of SupplySide Supplement Journal Theodora ("Teddy") McCormick of Epstein Becker & Green, P.C. Asa Waldstein of Supplement Advisory Group and Apex Compliance View Event Schedule Previous Next

Asa Waldstein quoted < Back FDA, FTC slap CBD industry with seven warning letters related to COVID claims Hemp Industry Daily Relevant Article Asa Waldstein quoted Read More Previous Next

Use caution copy & pasting “ingredient benefits” onto commercial website < Back Learning targets: Children, risky words, intranasal, ingredient benefits Use caution copy & pasting “ingredient benefits” onto commercial website #WarningLetterWednesday is a cautionary tale for companies new to the space that are looking to market products. This company looks like a groovy crystal shop that started making topical products and products delivered to the eyes and nose. So what can we learn? 🔷Of course, there are high risks words referenced in the warning letter, Notably, the use of viruses, cancer, and so many more! 🔷Products delivered through the nose (intranasal) or as an eye drop are drugs and have a justifiable higher level of scrutiny. 🔷Products marketed for use by children are high-risk. 🔷This warning letter is a good teaching tool. Copying and pasting a product's "therapeutic uses" from a textbook or website is a great way to get into trouble. This appears to be the case here. ➡️From warning letter Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts). 🔷I understand these are obvious high-risk claims, but in some ways, this could have happened to any entrepreneur that doesn't understand the rules of marketing products. I have seen this happen several times with practitioners, herbalists, and even doctors that "cross the line" into marketing claims by using common therapeutic language such as anti-inflammatory and even "clears heat and resolves toxins." We talk about this here . ➡️From warning letter .... to heal skin irritations and scarring. 🔷Interestingly, there are a couple of references to helping skin irritations and scarring. I do not consider these to be high risk. They are likely a "pig pile" or a common secondary claim in warning letters. What are your thoughts on the risk level here? Read warning letter here . 👉In closing, I think the FDA would have left this company alone if there were not talking about viruses, selling products that go into the nose and eyes, are marketed as safe for children, and had just too many disease words to be avoided. I started a LinkedIn group just for warning letter discussion. Join 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!

High risk “buzzwords” attract FDA/FTC “keyword web crawlers” < Back Step #1 in reducing risk is removing high-risk “buzzwords” High risk “buzzwords” attract FDA/FTC “keyword web crawlers” #WarningLetterWednesday Step #1 in reducing online marketing risk is removing high-risk "buzzwords". These include Alzheimer's, cancer, diabetes, PTSD, opioid support, depression, and of course COVID. Other "buzzwords" include pain, anxiety, inflammation, and arthritis. Today's warning letter is a smorgasbord of "buzzwords". Read it here . Authorities look at the 10,000-foot view of a company's online persona. One "buzzword" will likely not attract a warning letter, but claims on social media, videos, blogs, product reviews, hashtags, and ingredients descriptions elevate risk. The authorities piece them together for one big picture of noncompliance. The more "buzzwords" the higher chance of scrutiny. I suggest removing or replacing them with truthful, accurate, and not misleading options. Examples: Pain <> Discomfort Anxiety <> Mental resilience or balanced mood support Flu <> Seasonal immune support 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!

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!

Scan socials and websites for risky words like “hordenine” < Back Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter Scan socials and websites for risky words like “hordenine” The warning letter has a unique “we offer the following comment” section. FDA references bitter orange extract (Citrus aurantium) as an ingredient in the Supplement Fact Panel. It then refers to the product ingredient page where the company states that ingredients like hordenine are components of bitter orange extract. From warning letter. “Bitter orange extract contains neuroactive agents, synephrine, hordenine, and octopamine.” This is detailed diligence by FDA, showing that small copywriter comments can lead to increased scrutiny. FDA goes on to mention the previous hordenine and octopamine warning letters. I write about this here . I suggest scanning websites to see if keywords such as hordenine and octopamine show up. I offer this service and can do this at no charge if you mention “Warning Letter Wednesday.” Many of the claims cited in this warning letter involve the company discussing ingredient benefits. I wrote about this on a #WarningLetterWednesday just a few weeks ago. Blood sugar claims enforcement continues to be top of mind for FDA, and there are several citations in the warning letter. I review 56 diabetes-related warning letters here. Old social media posts are also mentioned in this letter. This includes a post from early in the pandemic with the high-risk word “coronavirus.” I would guess the company had long forgotten about this post. Here is a WLW write-up and video about this. Words ending in “itis” (meaning “inflammation of”) are disease claims, and the most commonly cited “itis” in warning letters is arthritis. This letter references five occurrences of this word, demonstrating that words like arthritis do not belong in supplement marketing. Read the 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!

Ensure 483 responses are complete < Back Incomplete Batch Records & Ingredient Specifications Ensure 483 responses are complete This letter is a great reminder of the basics of Good Manufacturing Practices, starting with developing specifications to ensure the ingredients and products are correct and not contaminated with microbials or heavy metals. FDA inspected this company in January and February last year, and they provided 483 responses over the next couple of months. The findings during the inspection and the incomplete 483 responses led to this warning letter. Ingredient Heavy Metal Specifications: 🔹From warning letter. “You did not provide any heavy metal or microbial test specifications for your Acetyl-glutathione component.” Batch Production Record (BPR) Issues: 🔹From warning letter “A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f)).” 👉 Asa comments: This is important to identify whether ingredients were added correctly. For example, a lower-than-expected yield could signify missing ingredients or low capsule fill weight. 🔹From warning letter. “Documentation, at the date and time of performance, of labeling operations (21 CFR 111.260(k))” 👉 Asa comments: This is essential to verifying when processes were conducted, which can help identify issues before the product is released to the public. 🔹From warning letter. “An actual or representative label, or a cross-reference to the physical location of the actual or representative label used in production (21 CFR 111.260(k)(2))” 👉 Asa comments: Batch production records are recipes built in conjunction with the product label. Cross-referencing the label is a key part of ensuring the formula and label match. Master Manufacturing Record (MMR) Size: Each formula size should be its own MMR. 🔹From warning letter. “The MMR you provided in your April 8, 2024, response….not specific to a unique formulation of a dietary supplement and is not specific to batch size. Incomplete 483 Responses: The bizarre thing about the warning letter is that it could have been prevented. 🔹From warning letter. “Your response dated April 8, 2024, includes a document titled Returned Product Procedure. However, the procedure does not address the requirement for quality control to conduct a material review and make a disposition decision, as required by 21 CFR 111.510. The procedure states that the food safety officer will perform these activities.” 🔹Here is another reference to an incomplete 483 response. “Your current finished product specification sheet for your Acetyl-glutathione product lists the test method as N/A.” Quality Must Investigate To Prevent Bigger Potential Issues: The following section of the warning letter speaks to a core principle of GMPs: if there is a safety issue due to a product return, the company is required to ensure the return is not related to a problem that affects other batches. This does not need to be complicated, but it should be part of a product complaint or product return SOP. 🔹From warning letter related to the Returned Products Procedure. “Furthermore, the procedure also does not address the requirement that if the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of the manufacturing processes and each of those other batches to determine compliance with specifications.” There’s a lot more in this warning letter . DATE ORIGINALLY POSTED: 1/22/25 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!