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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!

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!

< Back Podcast Monday Apr 24, 2023 GMPs and Dietary Supplements: A Conversation With the Experts CHPA Chat If you are in the consumer healthcare industry, you probably know about GMPs, or Good Manufacturing Practices. But what do they specifically mean when it comes to dietary supplements, and how do VMS companies prepare for an FDA inspection? Listen Previous Next

FDA will test suspicious products for drugs < Back Male Enhancement Products Found with Drug-Spiked Ingredients FDA will test suspicious products for drugs FDA has issued two drug-spiked product warning letters this year! This is the type of action I appreciate seeing the FDA do, as this small number of bad actors in the market gives the dietary supplement industry a bad name. Sign up for my weekly Warning Letter Wednesday post. FDA tested these products and found them to contain active ingredients in Viagra and Cialis. The company's product claims about erectile dysfunction likely triggered FDA to test these products, and several ED claims are cited in the warning letters. Erectile dysfunction may be considered a disease claim and should be avoided. But how about libido, sexual performance, and aphrodisiac claims? Do you think these types of statements are structure-function statements? In my opinion, libido-type claims attract FDA attention and require additional testing on Amazon, but they, if substantiated, are likely in the lower-risk category as long as companies are testing to ensure there are no unintentional drug-spiked ingredients. I rarely tell jokes on Warning Letter Wednesday, but I can’t help this one. “Why did the lizard go to the doctor?... He had reptile dysfunction.” In this warning letter , the timeline is perplexing. FDA inspected the manufacturer and conducted a website review in June 2022. FDA tested a product and found the presence of sildenafil which is the active ingredient in Viagra. Then in August 2022, the company issued a recall for one lot of the seven-count product. Two months later FDA issued a public notification warning consumers about these products, and now in January 2023, the company was issued a warning letter. What can we do to help get these drug-spiked products off the markets sooner? This warning letter from yesterday also has an even more bizarre timeline. FDA reviewed the website and potentially tested products in May 2022. In July 2022 FDA issued a public notification warning consumers about the presence of tadalafil in these products. Then, just last month FDA re-reviewed their website and found the company apparently still selling these products, which led to this warning letter. Again I ask, ‘What can we do to help get these drug-spiked products off the markets sooner?’ 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!

Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. < Back Q1 2024 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. Read More Previous Next

The head of FDA's Office of Dietary Supplement Programs and a dozen others offered their perspective on the recent DSHEA at 30 Summit in Salt Lake City. < Back FDA, industry experts reflect on DSHEA at 30 Summit Josh Long Interview The head of FDA's Office of Dietary Supplement Programs and a dozen others offered their perspective on the recent DSHEA at 30 Summit in Salt Lake City. Asa Waldstein, principal, Supplement Advisory Group: “The DSHEA Summit was a well-structured and moderated event that provided a wonderful opportunity for stakeholders in the natural wellness space to come together, appreciate and contextualize the origins and initial purposes of DSHEA, align concerning the current status of regulation in the space, and exchange ideas about what adjustments or improvements are needed. We need to use this opportunity to move forward in achieving our shared goals together. DSHEA is a remarkable statute that accomplished both expected and unexpected results. We should work to improve upon DSHEA and not simply abandon it or rush into new legislation that betrays its underlying principle of empowering consumers to make informed decisions about managing their own health and wellness.” 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