FDA warning letter gives important lessons for finished product testing, labeling and adverse event reporting


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FDA warning letter gives important lessons for finished product testing, labeling and adverse event reporting
A new warning letter from FDA for a company manufacturing products that contained only 5% of declared nutrient levels shows that the agency is stepping up its testing of finished products, say industry experts.

A letter dated May 22, 2013 to Jay Connaughton, CEO of Metaugus, Inc. in Cedartown, GA, available here​, concerned a product, Biotin 3,000 mcg. (3 mg) manufactured for an own label distributor. FDA alleges that the product is misbranded in that the labeling is false and misleading.

“The label for this product states that it provides 3000 mcg (3 mg)/serving (2 tablets) of biotin. However, our laboratory found the biotin content in the analyzed sample to contain 0.168 mg/serving of biotin (5.6% of declared) on the first analysis and 0.15 mg/serving of biotin (4.99% of declared) on the repeat analysis,” ​stated the letter.

“Under Title 21, Code of Federal Regulations, Part 101, specifically 21 CFR 101.9(g)(4)(i), a food product is misbranded if the content of the added nutrient (in this case, biotin) is not at least equal to the value for the nutrient declared on the label of the product.

“Therefore, your product is misbranded because the label declares 3 mg/serving of biotin but our laboratory results demonstrate a lesser amount of biotin present in your product.”

A spokesperson for Metaugus Inc told NutraIngredients-USA that the company is addressing the issues raised in the warning letter and is working with the FDA to deal with it appropriately.

Finished product testing

The warning letter appears to validate the prediction made by Aaron Secrist, Quality & Regulatory Manager for NOW Foods during an interview with NutraIngredients-USA at SupplySide West show in Las Vegas last year. Secrist told us that, as FDA inspectors gain more experience and move beyond the first tier GMP compliance issues, they are going to start ask a whole new set of questions.

“Instead of, ‘Are you are doing finished product testing?’ the questions will be, ‘How are you testing? What are you testing? What are you not testing? What is your rationale for not testing?’” ​he said. To watch the full interview, please click here​.

Secrist told us today: "I think the warning letter clearly demonstrates that the FDA is moving past some of the basic foundational GMP issues such as specifications, SOPs and master manufacturing records to address what companies are doing to ensure that their label claims are met through finished product testing.  I expect there will be more warning letters to come in this area.”

Creating a heightened awareness

Loren Israelsen, president, United Natural Products Alliance (UNPA), told us: “We note that FDA continues to deepen the scope of its Section 111-related investigation criteria. This warning letter reaffirms FDA’s willingness and ability to test and verify nutrient content claims. If FDA is testing your products, it's clear that the brand holder should be the first to know, not the second. 

"Earlier conversations between industry and FDA have largely focused on ingredient identity testing, and rightly so. 

“This latest news will no doubt create a heightened awareness among contract manufacturers and brand holders. It’s clear that brand holders should exercise independent due diligence with respect to finished product testing."

A slant rather than a step

Steve Mister, CEO and President of the Council for Responsible Nutrition (CRN), told NutraIngredients-USA that he didn’t see this as a step up for FDA GMP enforcement, but more of an upward slant.

“With this warning letter, FDA is signaling to this company and the industry that it is taking GMPs very seriously. The letter lists three violations and all three are things that companies should have as part of their standard operating procedures,” ​he said.

“This warning letter says to me that something was going wrong in the manufacturing process. Either there was an input problem, a manufacturing problem, or the company didn’t do the finished product testing as the GMPs require.”

Indeed, the spokesperson from Metaugus stressed that in addition to identity testing, mixability testing is important for dietary supplement companies to monitor. One of the issues that companies should address is when a mix is not completely homogeneous, or a batch of a mix is striated, this leads to issues. "We're addressing this right now,"​ he added. 


A second violation listed by FDA in its warning letter is alleged misbranding of the Biotin product “within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to bear the name of each dietary ingredient.

“The product also is misbranded under section 403(q)(5)(F) [21 U.S.C. § 343(q)(5)(F)] because the label fails to include the quantity of each dietary ingredient (or of a proprietary blend of such ingredients) per serving.

“Specifically, the nutrition information of your label declares ‘Minerals (as 74 minerals and trace minerals),’ but does not name the minerals or their quantities per serving.

“If a dietary supplement product makes a claim about containing minerals or they are added for the purpose of supplementation, then each mineral must be declared in the nutrition information in accordance with 21 CFR 101.36(b).”

Commenting on this particular point, Justin Prochnow, shareholder at the Denver office of Greenberg Traurig, LLP, said: “This statement from FDA affirms its position that you may not make claims about nutrients that are not specifically identified in the Nutrition Facts on the label or ingredients that are not specifically identified in the list of ingredients.”


The final violation cited by FDA in the warning letter related to adverse event reporting (AERs), with the Agency alleging that the biotin product is also misbranded “within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C. § 379aa-1(b)], may receive reports of serious adverse events associated with the product.”

CRN’s Steve Mister said that FDA has been pretty vocal about AERs in recent months and the subject is getting more attention, “and I think it should”, ​he said.

“GMPs are there to ensure consumers are getting what they think they’re getting. Nothing in this warning letter should come as a surprise to anyone.”

To read our recent interview with Dr Rick Kingston from SafetyCall International about AERs, please click here​. 

Related topics Regulation GMPs, QA & QC

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