Supplement makers from Washington, Maine and Georgia, along with seafood and juice processors from New York and Jamaica, are on notice from the Food and Drug Administration for violations of federal food safety rules.
The FDA sent warning letters to the companies in April, November and December of 2017, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.
In a Dec. 14, 2017, warning letter to distributing agent Jared K. Lykken, the FDA cited serious violations of the Food, Drug, and Cosmetic Act, and determined that the firm’s misbranded dietary supplement do not comply with FDA requirements.
“In addition, FDA reviewed your website at www.brainalert.com. Based on our review, we have concluded that your BrainAlert product is an unapproved new drug and misbranded drug and that, even if it were not a drug, it would be a misbranded dietary supplement.”
According to the warning letter, the firm’s products were prepared, packed, or held under conditions that do not meet Current good manufacturing practice (CGMP) requirements for dietary supplements. During the inspection, the investigator observed the following violations of the FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements:
- The firm failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record:
“For example, you stated that you have no knowledge of how your contract manufacturer manufactures or handles your product prior to your receipt of the finished product, or whether your contract manufacturer conducts any testing of the product.”
- The firm failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision:
“To fulfill requirements for quality control operations, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.”
- The firm failed to establish and follow written procedures to fulfill the requirements related to product complaints:
“You have not established written procedures for handling product complaints.”
- The firm’s BrainAlert product is misbranded because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e. Ginseng (Panax), Rhodiola rosea, Ginkgo Biloba, and Gotu Kola, in the product is derived; and
- The firm’s BrainAlert product is misbranded in that the presentation of the nutrition information on the labeling is incorrectly listed.
Maine Natural Health Inc., Warren, ME
In an April 12, 2017, warning letter to company owner and CEO Harold J. Leighton, the FDA cited serious violations of the Food, Drug, and Cosmetic Act (the Act), and determined that the firm’s misbranded dietary supplements do not comply with FDA requirements.
“In addition, we have reviewed the labeling for your dietary supplements, including product labels and your website at www.sfh.com. Based on our review of the labeling and the website, we have concluded that your SO3 + D3 Fish Oil, Fuel Whey Protein, Strong Strength + Muscle, Pure Whey Protein, and Push Pre-Workout products are in violation of the Act and regulations implementing the food labeling requirements of the Act.”
According to the warning letter, the adulterated dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements due to the following violations:
- “You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record”
- “Your firm failed to collect representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications”
- ” When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the component or dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR)”
- “The firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch”
- “The firm’s Strong Strength + Muscle, and Push Pre-Workout products are misbranded in that their labeling is false and misleading”
- “The firm’s Pure Whey Protein and Fuel Whey Protein dietary supplement products are misbranded because the labeling bears nutrient content claims, but the products do not meet the requirements to bear the claims”
- “The firm’s Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name”
- “The firm’s Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded because of the presentation of the nutrition information on the labels”
- “The firm’s Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded because the serving sizes and servings per container are not listed in the Supplement Facts labels in the format” and
- The firm’s product labels do not list the name of the manufacturer, packer, or distributor, and lists the net weight in total ounces, rather than pounds and ounces.
Dynamic Technical Formulas, Roswell, GA
In a Dec. 13, 2017, warning letter to company owner and COO William T. Wotiz, the FDA cited serious violations of the Food, Drug, and Cosmetic Act (the Act), and determined that the firm’s misbranded dietary supplements do not comply with FDA requirements.
According to the warning letter,”the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The inspection also revealed violations of dietary supplement labeling requirements, rendering your DTF, Gym Candy, and Biotech Underground products misbranded.”
The FDA investigator noted the following violations:
- The firm’s quality control personnel failed to ensure that their manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record
- The firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that they manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch
- The firm failed to prepare a batch production record every time they manufactured a batch of a dietary supplement
- The firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record
- The firm failed to identify each unique lot within each unique shipment of components that they receive and any lot of components that they produce in a manner that allows them to trace the lot to the supplier, the date received, the name of the component, the status of the component; and to the dietary supplement they manufactured and distributed
- The firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that they distribute
- The firm failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained and
- The firm’s OmegaFuel product label declares fish oil, but fails to declare the major food allergen “fish”
According to the warning letter, “We reviewed the labeling of your Lift Candy, Pump Candy, Clafuel, Joint Fuel, DHEA fuel, Pump Fuel, OMEGA fuel, Night fuel, Organ fuel, Purify and Tudca products and found that these dietary supplements are misbranded in that the labels fail to identify a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.”
Gold Star Smoked Fish Corp., Brooklyn, NY
In an Dec. 15, 2017, warning letter to company president Robert Pincow, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, and determined that the firm’s ready-to-eat (RTE) seafood products are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
During the inspection, the FDA collected environmental samples consisting of multiple swabs taken from various areas in the facility, “including areas that are near food during processing operations and near food contact surfaces.” According to the warning letter, FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes in the facility.
The FDA’s laboratory analysis of environmental sample collected on May 12 confirmed that five environmental swabs tested positive for Listeria monocytogenes. The positive swabs were collected from surface areas in locations where Ready-To-Eat (RTE) cold and hot smoked seafood products are manufactured and packaged.
FDA laboratory analysis of the environmental sample “INV987101” collected at the firm’s facility on April 26, 2017, confirmed that 15 of one 110 environmental swabs were positive for L. monocytogenes.
Specifically, “11 of the 15 positive swabs were taken from wheels of stainless steel carts (also referred to as tanks) used to thaw, brine and transport seafood products,” indicating that the facility is not achieving “satisfactory control” against the presence of Listeria monocytogenes within their facility and implementing effective methods and controls to locate niche or harborage points of the organisms within the environment to eliminate and minimize exposure to food and food contact surface during production.
“The presence of a resident strain of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food,” FDA determined.
The FDA acknowledged a June 5 response outlining the corrective actions taken in response to the L. monocytogenes environmental sample findings. “We acknowledge that you have cleaned and sanitized your processing environment, conducted environmental sampling, and that finished product was tested for L. monocytogenes. Your response also describes intensified environmental sampling being conducted after cleaning and sanitizing and before resuming production. At this time, we cannot verify the adequacy of the methods and controls you have used to identify the potential harborage sites for L. monocytogenes in your processing environment or that the methods and controls effectively prevent L. monocytogenes from contaminating finished products you may manufacture in the future. We will verify the adequacy of your corrective actions during any future inspection.”
Naturefield Company, Kingston, Jamaica
Naturefield Company in Kingston, Jamaica is on notice from the FDA because of significant deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act). The firm ships frozen 100 percent coconut water in retail packaging into the United States.
The warning letter went out after the firm’s response to the FDA’s request for a copy of HACCP documentation associated with the processing of it’s 100 percent coconut water. Staff from the FDA discovered the “serious violations” regarding the firm’s affected products, according to the Nov. 16 warning letter made public by the FDA in recent days.
“You must include in your HACCP plan control measures that will consistently produce, at a minimum, a S log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism,” However, “your HACCP plan for 100% coconut water, a low-acid juice product, does not include control measures that will consistently produce a 5-log reduction of the pertinent microorganism, Clostridium botulinum,” according to the warning letter sent to company contact Patrick Powell.
FDA officials encouraged the firm to review the Act, the juice HACCP regulation, the Juice HACCP Hazards and Controls Guidance, and the Refrigerated Carrot Juice and other Refrigerated Low-Acid Juices Guidance through links in FDA’s homepage.
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