GMP, Claim And Label Warning Follows Firm's Ephedra Recall

FDA Office of Regulatory Affairs' warning letter to MusclMasster lists 12 separate violations of supplement GMP regulations. Puerto Rico firm is latest supplement own-labeler to receive GMP warnings.

A Colorado herbal supplement firm received an FDA warning letter about extensive good manufacturing practices problems and violative claims three months after recalling an ephedra-containing product and after questioning why it should document production yields.

An Aug. 30 warning letter to MusclMasster LLC from the Denver District of FDA's Office of Regulatory Affairs lists 12 separate violations of supplement GMP regulations, most described with multiple examples of noncompliant practices that ORA officials noted during an inspection in February at the firm's Wheat Ridge, Colo., facility (see table below).

With most of the listed violations, ORA included a statement acknowledging that MusclMasster submitted a response on March 28 to agency officials' form 483 findings. In each instance, though, ORA officials stated they were "unable to evaluate the adequacy of your corrective action because you have not provided documentation."

Domel, Dermixx Distributor Dinged

Puerto Rico dietary supplement marketer Lopez Gonzalez Santana Corp., which distributes Domel and Dermixx brand products, is the latest own-labeler warned by FDA about GMP and other violations.

Officials from ORA's San Juan District inspected the firm's facility in Rio Piedras in January and February and submitted a warning letter on Aug. 28. The letter published Sept. 19 repeats a statement FDA has made to numerous own-label supplement marketers since the agency began GMP inspections in the industry in 2010: "As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, you have an obligation to know what and how manufacturing activities are performed."

LGS Corp.'s GMP problems track with those FDA most commonly finds, including failing to establish and follow written procedures for the responsibilities of the quality control operations and to establish product specifications for the identity, purity, strength, and composition of the finished batch of the supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the supplement.

It also was warned about misbranding such as a product label failing to identify the product by using the term “dietary supplement” and to declare the common or usual names of each ingredient.

In its response to ORA's finding that it did not compile complete information for production and control of each manufactured batch, MusclMasster said that following the agency's inspection it began including "all necessary elements" in its batch production records, "except for a statement of actual yield and percentage of theoretical yield," but it has "no idea how to do this and fail to see the value in doing this suggestion."

ORA did not grant a pass on their requirement. Instead, it said, as it did for the firm's responses to other GMP violations, that it could not evaluate the adequacy of MusclMasster's corrective action "because you have not provided revised documentation which includes complete information relating to the production and control of each batch," according to the letter FDA published Sept. 19.

The warning also acknowledges the firm stated it voluntarily destroyed all ephedra-containing ingredients and supplement products found during a second inspection of its facility, from late March through early May, that ORA began after reviewing MusclMasster's website. It also recalled its product found to contain ephedra, AL-ER-G. (Also see "More Ephedra Found, Sibutramine Crime In Texas: Health And Wellness Industry News" - HBW Insight, 24 May, 2017.)

Unapproved New Drugs, Misbranding

ORA's review of MusclMasster's website found claims that rendered its products unapproved new drugs in general statements about the firm and its products and in text about specific products.

General statements making violative claims included “I started taking herbs for diabetes … Results were almost immediate,” while product claims varied from saying its Vas-Q-Lar supplement is "beneficial for asthma, dementia, depression, eczema, headaches, heart and kidney disorders, and tinnitus" to describing its Nu Woman products as a "sedative to pain and distress in kidneys and bladder,” according to the warning.

Additionally, in MusclMasster's product labeling ORA found misbranding common among supplements firms that have received warning letters noting drug claim and GMP problems. "Even if these products were dietary supplements and/or were not unapproved new drugs/misbranded drugs, they would be misbranded," the letter states.

Misbranding was evident in labels failing to:

• present nutrition information in the form of a “Supplement Facts” panel;
• identify the part of the plant from which each botanical dietary ingredient in a product is derived;
• bear a domestic address or domestic phone number for reporting adverse events to the company;
• list the name and place of business of the manufacturer, packer, or distributor;
• identify the species of fish from which the fish liver oil is derived for a product that contains a major food allergen, fish;
• include the quantitative amount by weight per serving size of all the dietary ingredients
• list capsule ingredients;
• declare the number of servings per container.

ORA said the firm also failed to label its supplements formulated with iron with this required warning statement: "Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”

MusclMasster Supplement GMP Omissions
Written procedures for the responsibilities of its quality control operations.	Component specifications necessary to ensure that specifications for the identity, purity, strength, and composition of dietary supplements manufactured using the components are met; and finished product specifications for the identity, purity, strength, composition and limits on contamination for any of the dietary supplement products it manufactures.
Of 10 batch production records FDA reviewed, none included complete information for the production and control of the batch.	Master manufacturing record does not contain all required elements.
Establish and follow written procedures for holding and distributing operations.	Collect and hold reserve samples of each lot of packaged and labeled dietary supplement that it distributes.
Records related to employee training.	Written procedures for packaging and labeling operations.
Written procedures for handling product complaints.	Written procedures for returned dietary supplements.
No written procedures for equipment and utensils.	No written procedures for cleaning the physical plant and for pest control.

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.