NDI Notification Estimate Unchanged: Health And Wellness Industry News
This article was originally published in The Rose Sheet
Executive Summary
Biotek gets FDA's own-labeler lesson; MyNicNaxs shut down after ignoring warning; and FDA sticks with NDI notification cost estimate.
MyNicNaxs shut down after ignoring warning
A Florida business selling weight loss and sexual enhancement products under brands commonly used for adulterated dietary supplements has been ordered to shut down until it complies with FDA regulations. FDA and the Department of Justice on March 28 said US. District Court for the Middle District of Florida entered a consent decree of permanent injunction against MyNicNaxs LLC of Deltona, Fla., its owner Chevonne Torres and a company officer, Michael Banner. MyNicNaxs marketed online products labeled as supplements but containing undisclosed sildenafil, an active pharmaceutical ingredient indicated for erectile dysfunction; sibutramine a drug ingredient withdrawn from the US market after clinical data indicated that it poses an increased risk of heart attack and stroke; and phenolphthalein, an ingredient FDA has not approved because studies indicate it is a potential carcinogenic risk.
According to DoJ's complaint filed March 14, MyNicNaxs' products bore brands commonly found in FDA's enforcement against imported supplements found to contain drugs, including "African Viagra," "Body Beauty Slimming" and "Moneysteel Sex Pill." The firm was targeted in litigation after failing to correct problems FDA noted in a 2015 warning letter. (Also see "Regulatory News Roundup: Two Customs Strikes Against MyNicNaxs, U.K. Ad Enforcement" - Pink Sheet, 16 Mar, 2015.) “Despite previous warnings, MyNicNaxs continued violating the law," said Donald Ashley, Office of Compliance director in FDA’s Center for Drug Evaluation and Research. The injunction requires MyNicNaxs to cease distributing unapproved new drugs or misbranded drugs and receiving, manufacturing, holding and distributing any drugs or supplements until it receives a written notification from FDA stating that it appears to be in compliance and it may resume operations.
FDA sticks to NDI notification cost estimate
FDA maintains its estimate for the costs of preparing and submitted new dietary ingredient notifications at a level the dietary supplement industry rejects as too low. In its March 28 Federal Register notice for comment on its annual estimate, FDA acknowledges stakeholders' opposition. "We have made no adjustments to the currently approved burden estimate," but while the agency has "received comments previously suggesting our burden estimate may be too low, the comments did not discuss the basis for such a conclusion," the notice states. FDA says based on NDI notifications over the past three years, it estimates that 55 firms or other parties will submit one notification each in 2018 and that "extracting and summarizing the relevant information from what exists in the company's files and presenting it" in the required format will entail around 20 hours of work per notification, for a total industry burden of 1,100 hours for the year.
Just as they do much of FDA's draft guidance on submitting NDI notifications, industry stakeholders question the agency's calculations to determine the cost estimate (Also see "NDI Notification Costs Estimate, P&G Board: Health And Wellness Industry News" - HBW Insight, 16 Nov, 2017.) It limits the costs that it says firms incur to the document preparation needed to submit a notification and does not include firms' costs for research on an ingredient due to its position that firms should research ingredients for a reasonable expectation of safety regardless of whether they plan to introduce an NDI. The industry contends that NDI research is an expense that is part of firms' costs for submitting notifications, not a cost they would incur otherwise, and that the amount and scope of information required in an NDI notification to show an ingredient is reasonably expected to safe for its intended use exceeds FDA's estimates stated in two draft guidances. FDA published its initial NDI notification draft guidance in 2011 and a revised version in 2016 but has not indicated when it expects to finalize the guidance. (Also see "NPA Submits Wish List For Reducing FDA Regulatory Burdens Per Trump Order" - HBW Insight, 12 Dec, 2017.)
Biotek gets FDA's own-labeler lesson
Layton, Utah, firm Bioteck Inc. is the latest dietary supplement marketer to learn from FDA that contract manufacturers aren't responsible for own-labelers' compliance with the agency's regulations. A March 13 warning letter from the Office of Regulatory Affairs' Division IV West in Denver also stated the firm made drug claims for its products, such “Immune system is improved helping to combat stress and disease” for its Bio-35 and “Lipase enzymatically converts triglycerides, which have a tendency to clog veins and arteries" for its Lipotropic Formula. GMP problems ORA officials found during an August 2017 inspection included deficiencies common with noncompliant own-labelers as well as problems FDA frequently finds with firms that manufacture their own products.
Biotek's GMP violations common in the own-labeler space are:
- not establishing and following quality control written procedures pertaining to its operations as a repacker, labeler, holder, and distributor of dietary supplements;
- not having a system of production and process controls to ensure the quality of products it receives from contract manufacturers and that the products are labeled as specified in the master manufacturing record;
- not having any specifications to identify the products it receives are consistent with its purchase orders;
- not establishing label and packaging specifications for supplements it receives in bulk from contract manufacturers for repackaging and labeling.
Its GMP problems common across the supplement space are not having specifications for packaging and labeling of finished, packaged and labeled supplements, not preparing and following written master manufacturing and batch production records; not collecting reserve samples of each lot of packaged and labeled supplement it distributes; and failing to establish and follow written procedures for:
- cleaning its physical plant and grounds and for pest control;
- packaging and labeling operations;
- fulfilling requirements related to returned products;
- calibrating, inspecting and checking automated, mechanical, and electronic equipment, and for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils and any other contact surfaces used to package, label, or hold components or supplements.
Biotek's responses to ORA inspectors' findings, submitted in September and February, stated the problems would be corrected in three months but FDA said it is unable to evaluate the adequacy of the corrective action because the firm did not specify how the observation would be corrected or provide documentation to show it had been corrected.
Misbranding noted from ORA's inspection included failing to declare the presence of major food allergens present in a products, to identify a product by using the term “dietary supplement" and to declare all the common or usual names of each ingredient in a product. Biotek also stated incorrect serving sizes on labels, omitted information on coloring in a product and used incorrect formatting on some labels, according to the warning.
From the editors of the Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the website.