GMP-Deficient Supplement Own-Labeler Also Dabbles In OTC Drug Sales

Mega-Pro Nutrition is one of two own-labelers, along with Vicare International Inc., warned on GMP violations in warning letters FDA published Sept. 26. A third supplement firm, Newton-Everett, was warned about making extensive drug claims for its products, including in social media posts.

One of the latest dietary supplement own-label marketers to receive an FDA warning letter also conducts online sales of OTC drugs containing epinephrine, a methamphetamine precursor ingredient subject to federal and state sales limits.

Mega-Pro Nutrition Inc. was one of two own-labelers, along with Vicare International Inc., warned on good manufacturing practices violations according to warning letters FDA published Sept. 26. A third supplement firm, Newton-Everett LLC, was warned about making extensive drug claims for its products, including in social media posts.

While firms that market under their own brands vitamins, minerals and supplements supplied by contract manufacturers have been common targets for GMP warnings from FDA's Office of Regulatory Affairs, Mega-Pro, of St. George, Utah, is notable as a business that also sells OTC drugs under the same brand it uses for some supplement products, Vasapro.

However, the firm's website states that it does not send Vasapro Epinephrine to 12 states with restrictions more stringent than federal limits on consumer access to nonprescription products containing methamphetamine precursor ingredients.

Additionally, Mega-Pro says it currently does not have any epinephrine products in stock.

While pseudoephedrine is the more commonly used ingredient subject to the Combat Methamphetamine Epidemic Act of 2006, the act's requirements for behind-the-counter sales, daily and monthly purchase limits and for retailers to log purchasers' identities also apply to nonprescription drugs containing epinephrine. (Also see "NPLEx Brings A ‘Quiet’ Year On State PSE Legislation – CHPA" - Pink Sheet, 8 Jul, 2015.)

Usual Suspects Of Own-Labeler GMP Errors

The ORA Denver District's Aug. 25 letter to Mega-Pro lists usual suspects of supplement GMP problems, failing to establish and follow written procedures for quality control operations' responsibilities, for requirements related to product complaints and to fulfill requirements related to returned dietary supplements.

The letter to Mega-Pro also notes requirements of FDA's 2007 supplement GMP final rule particularly problematic to own-labelers, failing to collect and hold reserve samples of each lot of packaged and dietary supplements it distributes and to establish and follow written procedures for holding and distribution operations.

During ORA's April inspection, Mega-Pro employees said the firm holds and distributes products and its "contract manufacturer(s) is/are responsible for all product specifications," but also said the firm works on developing products and has final approval. The firm is "responsible for the label design and label artwork for [its] products and that [its] contract manufacturer completes the supplement information section of the label."

Vicare International did not did not provide FDA with label and packaging specifications or revised finished product specifications for products including Vi‐Reishi.

However, as ORA previously have advised numerous supplement own-labelers, the office advised Mega-Pro that it "has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution."

ORA also notes that Mega-Pro supplements containing chromium picolinate, creatine and DHEA are rendered drugs by online claims including "play a role in lowering cholesterol, normalizing high blood sugar…” and “…linked DHEA depletion with almost every major degenerative disease.” Those products also are misbranded because they fail to bear adequate directions for their intended uses, which are as drugs.

The warning notes additional misbranding problems including products with labels that omit the term “Proprietary Blend” or similar descriptive term, the source of the synephrine extract and the identity of the part of a plant which each botanical dietary ingredient in a product is derived. Other misbranding noted was not listing ingredients in a proprietary blend in descending order by weight and in a column or linear fashion failing to correctly declare the heading % DV (Daily Value) and the % for each of the dietary ingredients listed, according to the warning.

Vicare's Response Incomplete

The Sept. 11 warning letter to Vicare International, in Alhambra, Calif., also notes its responsibility as an own-labeler for GMP compliance. "Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement [current] GMP requirements."

The ORA Los Angeles District sent a warning to Vicare after the firm's response to agency officials' form 483 findings did not provide adequate evidence of correcting problems found during an inspection in February and March of failing to establish specifications for each supplement for the identity and strength of finished batches and to establish specifications for labels and packaging that may come in contact with supplements.

ORA said the firm's response did not did not provide label and packaging specifications or revised finished product specifications for VicareVi‐Reishi and Super Cell and NuLife Nu‐Reishi products.

As it does in all warning letters to supplement and food product firms, ORA advises Vicare that the Food Safety Modernization Act authorizes FDA to assess and collect fees to cover "all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees," and that the agency "may assess fees [to Vicare] to cover any re-inspection-related costs."

Newton-Everett's FirstBiotic Advanced is one of the products FDA said was promoted to drug claims, including on social media posts.

However, since Congress passed FSMA in 2011 (P.L. 111–353) and FDA began in fiscal 2012 setting rates for other user fees authorized by the act, the agency is not collecting re-inspection or mandatory recall fees because it has not established a waiver for exemption from the fees. Facility registration user fees FSMA also authorized are collected from the supplement and food industries. (Also see "FSMA Re-inspection Fees MIA As Waiver Guidance Remains AWOL" - HBW Insight, 2 Aug, 2017.)

Social Media Trail Lasts

ORA's July review of Newton-Everett's website and its social media activity found violative claims including “may help eradicate human papillomavirus (HPV) in women” for its active hexose correlated compound product and "alleviation of eczema” and "prevent colon cancer” for its and FirstBiotic Advanced.

The ORA Denver District's Sept. 7 warning letter to the Scottsdale, Ariz., firm also points out claims rendering its supplements as drugs on a blog post from November 2012 and on postings on social media platforms going back to July 2014.

The letter explains to Newton-Everett that scientific literature noted in blog posts or other product promotions is considered an element of a product's labeled claims. "When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use," ORA states.

ORA found problems with information on Newton-Everett's Facebook page including a July 2014 post that featured an image of its Biovea panax ginseng, gingko biloba, and pycnogenol products and the claim, "Learn how these three remedies can … reduce ADHD symptoms.”

On Twitter, the firm in November 2015 shared images of its Biovea St. John’s wort, Maca and 5-HTP products with the statement, “These three #supplements can … help with #depression and #anxiety.” The warning also notes Instagram posting directing consumers to its website and featuring a photo of Biovea oregano oil (alcohol free) and a statement that the ingredient "is a natural antibacterial.”

Newton-Everett's claims make its products "intended for treatment of one or more diseases" not amenable to self-diagnosis or treatment without supervision of a licensed practitioner, making it "impossible to write adequate directions for a layperson to use" them safely for their intended purposes and causing them to be misbranded, according to the letter.

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 Rose Sheet website.