Q2 2020 Food and Dietary Supplement Warning Letters

The COVID-19 pandemic dominated news headlines in Q2. This naturally seeped into the FDA’s food and dietary supplement Warning Letters for the quarter. FDA issued a number of Warning Letters to dietary supplement firms for statements that certain products could prevent, treat, or cure COVID-19. These are listed below in their own special section.

In addition, FDA also issued Warning Letters to food and dietary supplement companies for Foreign Supplier Verification Program (FSVP), CGMPs, misbranded/adulterated products, and more.

FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP)

• David Rosen Bakery Supplies Inc. DBA David Rosen Company (Maspeth, NY) received a Warning Letter for failing to be in compliance with the requirements of 21 CFR part 1 subpart L for FSVPs for products manufactured by Grupo La Florida Mexico S.A. de C.V. (Tlalnepantla de Baz, Tlalnepantla, Mexico).
• Prime Line Distributors, Inc. (Fort Lauderdale, FL) received a Warning Letter dated April 9 for failure to submit FSVPs for hazelnut paste and Gran Padano Cheese imports.
• Fatima Brothers (Maspeth, NY) received a Warning Letter dated April 7 for failure to maintain an FSVP for boiled rice, cake rusk, and one other non-specified product.
• Promex Distribution LLC (McAllen, TX) received a Warning Letter dated April 13 for lack of an FSVP for carbonated mineral water and cornmeal products.
• SeaSnax (Commerce, CA) received a Warning Letter dated April 17 for not being in compliance with FSVP regulations for some of the company’s snack products.
• Kradjian Importing Company, Inc. (Glendale, CA) received Warning Letter dated May 4 for FSVP violations related to tahina imported from three foreign suppliers.
• Willis Ocean Inc. (Brooklyn, NY) received a Warning Letter dated April 30 for not being in compliance with FSVP regulations for a frozen vegetarian food product and spicy beef paste imported from overseas.
• Rajshree International, Inc. (Downey, CA) received a Warning Letter dated May 4 for failure to develop an FSVP plan for noodle and spice imports.
• K D Singh Enterprises LLC (Edison, NJ) received a Warning Letter dated April 8 for lack of FSVPs for three products.
• Maspeth Wholesale Corp (Maspeth, NY) received a Warning Letter dated May 14 for lack of an FSVP for a chili powder product.
• D.K. Grocery Inc. DBA Apna Bazaar Cash and Carry (Edison, NJ) received a Warning Letter dated May 14 for lack of an FSVP for food products the company imports.
• 88 Special Sweet, Inc. (South El Monte, CA) received a Warning Letter dated May 13 for not developing an FSVP for two products.
• Diamond Rock Food Imports Inc. (Copiague, NY) received a Warning Letter dated June 8 for failing to develop an FSVP for tomato sauce, refried beans, and soft drink products.
• H & C Food Inc. (Brooklyn, NY) received a Warning Letter dated June 22 for violations for two products, one a mushroom product and the other a seaweed snack product.
• Global Commodities Corp. (Hayward, CA) received a Warning Letter dated June 3 for FSVP violations concerning two fruit preserve products and one mixed nut snack product.
• Tiao Peng Trading, Inc. (Hayward, CA) received a Warning Letter dated May 19 for FSVP violations for a number of products.
• Pasha Food Distribution USA, Inc. (Tarzana, CA) received a Warning Letter dated May 18 for FSVP violations for three products.
• Copoliva Inc. (Van Nuys, CA) received a Warning Letter dated June 16 FSVP violations for a number of products.

SEAFOOD HACCP/CGMP FOR FOODS ADULTERATED/INSANITARY CONDITIONS 

• Macduff Shellfish -Scotland- Ltd (Aberdeenshire, UK) received a Warning Letter dated April 3 for failure to have an adequate Hazard Analysis and Critical Control Point (HACCP) plan. By default, this makes a product adulterated. Notably, the firm’s HACCP for rock crab products did not list the safety hazard of Clostridium botulinum toxins.
• Smoked Salmon Unlimited d.b.a. H. Forman & Son (London, UK) received a Warning Letter dated May 12 for lack of an adequate HACCP plan for cold smoked salmon.
• Cali Rice Valley Inc. (San Francisco, CA) received a Warning Letter dated May 29 for lack of HACCP for a ready-to-eat shrimp meal. Notably, this meal was not designed for further cooking by consumers, requiring a HACCP for ensuring control of bacteria by adequate cooking. Other CGMP violations were also noted, including employees sneezing into their hands before handling food.

NEW DRUG/LABELING/MISBRANDED 

• JusByJulie.Com LLC (Brooklyn, NY) received a Warning Letter dated April 13 for stating products, namely smoothies and juice cleanses, could be used to prevent, treat, or cure disease.
• Global Vitality, Inc. dba Enzyme Process International (Chandler, AZ) received a Warning Letter dated April 16 listing a number of statements from the company website that its products could treat or prevent disease. In addition, inspectors found CGMP violations at the company’s manufacturing facility.
• New Spirit Naturals Inc. (San Dimas, CA) received a Warning Letter dated May 7 for marketing five products as preventing or treating disease.
• Humaworm (Carrollton, MS) received a Warning Letter dated April 20 for claims that three products could remove parasites and fungi from the human body.
• LifeHealth Science (Twinsburg, OH) received a Warning Letter dated May 15 for website statements that the company’s ORËÁ product could prevent or treat disease.
• Medinatura Inc (Albuquerque, NM) received a Warning Letter dated June 11 for labels and website statements that six injectable products could prevent or treat disease. In addition, these products contained toxins including “mercurius solubilis” (mercury) and “embryo totalis suis.”
• World Health Advanced Technologies Ltd (Sarasota, FL) received a Warning Letter dated June 11 for statements that nine products, including two injectable products, could prevent or treat disease.
• Hevert Pharmaceuticals LLC USA (Boulder, CO) received a Warning Letter dated June 11 for statements on product labels that certain injectable products could prevent or treat disease. The products also potentially contained strychnine and lead according to labels.
• Morningstar Minerals LLC (Farmington, NM) received a Warning Letter dated June 1 for website statements that products could prevent or treat disease. In addition, two dietary supplements were misbranded.
• Only Natural, Inc. dba Bio Nutrition, Inc. (Oceanside, NY) received a Warning Letter dated June 18 for website statement and product label claims that products could prevent or treat disease.

CGMP/DIETARY SUPPLEMENT/ADULTERATED/MISBRANDED

• Hawaii Pharm LLC (Honolulu, HI) received a Warning Letter dated April 24 due to concerns about CGMP operations and misbranding for dietary supplement products.
• Lose Fat Gain Life M&B (Long Beach, CA) received a Warning Letter dated April 16 for marketing some products as preventing or treating disease. In addition, investigators determined that a weight loss pill was adulterated with 1,3-dimethylamylamine (DMAA), an unsafe food additive.
• NutraCap Labs LLC (Norcross, GA) received a Warning Letter dated May 21 for adulterated dietary supplements.

UNAPPROVED AND MISBRANDED RELATED TO CORONAVIRUS 2019 (COVID-19)

• NRP Organics Ltd (Canada) received a Warning Letter dated April 8 for statements on their website and social media that products could “mitigate, prevent, treat, diagnose, or cure COVID-19.”
• Earthley Wellness dba Modern Alternative Mama LLC (Columbus, OH) received a Warning Letter April 9 for statements on the company’s website and social media that the companies herbal tinctures and herbal remedy products for sale in the United States could treat, prevent, or mitigate COVID-19.
• Herbs of Kedem (United States) received a Warning Letter dated April 10 for statements on the company website that its herbal products could prevent or treat COVID-19.
• Gaia Arise Farms Apothecary (Waynesville, NC) received a Warning Letter dated April 13 for statements on the company website that certain products could prevent or treat COVID-19.
• Earth Angel Oils (Porter, TX) received a Warning Letter dated April 14 for statements on the company website that products could prevent or treat COVID-19.
• Copper Touch, LLC (North Branch, MN) received a Warning Letter dated April 21 for marketing products within the United States stated to prevent or treat COVID-19.
• Santiste Labs LLC (Doylestown, PA) received a Warning Letter dated April 27 statements on the company website that a transdermal patch product could potentially prevent or treat COVID-19.
• Hopewell Essential Oils (United States) received a Warning Letter dated April 27 for statements on the company website that essential oil and other products could prevent or treat COVID-19.
• Foxroids.com (United States) received a Warning Letter dated April 22 for website statements that products could prevent and treat COVID-19.
• Antroids.com (United States) received a Warning Letter dated April 22 for website statements that products marketed in the United States could prevent and treat COVID-19.
• Honey Colony LLC (Walnut, CA) received a Warning Letter dated May 4 for statements on the company website and social media that some products could prevent or treat COVID-19.
• Dr. Dhole’s Sushanti Homeopathy Clinic (Aurangabad, India) received a Warning Letter dated May 4 for statements that a homeopathic product for sale in the United States could prevent or treat COVID-19.
• GlutaGenic (Sarasota, FL) received a Warning Letter dated May 6 for offering viral protection kits marketed as preventing COVID-19.
• Alive By Nature, Inc. (Fleming Island, FL) received a Warning Letter dated May 6 for website statements that two sublingual gel products for sale in the United States could prevent or treat COVID-19.
• DrJockers.com, LLC (Acworth, GA) received a Warning Letter dated April 21 for statements on the company’s website and social media that certain products could prevent or treat COVID-19.
• Chronic Lyme Treatments (Canada) received a Warning Letter dated May 7 for statements that herbal products sold in the United States could prevent or treat COVID-19, making them in essence unapproved new drug products.
• WashingtonsLastFrontier.Com (United States) received a Warning Letter dated May 7 for promoting essential oils and dietary supplements as preventing or treating COVID-19. The company participates in the Amazon Associates program.
• Seanjari Preeti Womb Healing, L.L.C. (Spartanburg, SC) received a Warning Letter dated May 8 for statements on the company’s website and social media (including a YouTube video) that a honey product could prevent or treat COVID-19.
• Plum Dragon Herbs, Inc. (Chester, MD) received a Warning Letter dated May 8 for statements on the company website that its traditional Chinese medicine products could prevent or treat COVID-19.
• Fusion Health and Vitality LLC (Alpharetta, GA) received a Warning Letter dated May 11 for statements on company websites that products could treat or prevent COVID-19.
• White Eagle Native Herbs (Fort Davis, TX) received a Warning Letter dated May 14 for statements on the company websites that herbal products could prevent or treat COVID-19.
• benjaminmcevoy.com (United States) received a Warning Letter dated May 14 for statements on the company’s website that dietary supplement products could prevent or treat COVID-19. The company participates in the Amazon Associates program.
• Center for New Medicine/Perfectly Healthy by Connealy MD (Irvine, CA) received a Warning Letter dated May 6 for statements on company websites that certain products, including vitamins, could prevent or treat COVID-19.
• SpiceTac (Fleming Island, FL) received a Warning Letter dated May 19 for statements that a vitamin C product promoted on the Amazon Associates program could prevent or treat COVID-19.
• Life Unlearned, LLC (United States) received a Warning Letter dated May 19 for statements that vitamin D products promoted on the Amazon Associates program could prevent or treat COVID-19.
• 4nrx.md (United States) received a Warning Letter dated May 13 for statements on the company website that certain products could prevent or treat COVID-19.
• Emedkit.com (United States) received a Warning Letter dated April 22 for statements on the company website and social media that certain products could prevent or treat COVID-19.
• Roidsmall.net (United States) received a Warning Letter dated April 22 for statements on the company website that certain products could prevent or treat COVID-19.
• North Coast Biologics (Seattle, WA) received a Warning Letter dated May 21 for statements on the company website and social media that its “nCoV19 spike protein vaccine” product could prevent COVID-19.
• Careful Cents, LLC (Colorado Springs, CO) received a Warning Letter dated May 26 for statements on the company website that certain products could prevent or treat COVID-19. These were available on the Amazon Associates Program.
• Alternavita (United States) received a Warning Letter dated May 26 for statements on the company website that its grapefruit seed extract, colostrum, and cod liver oil products could prevent or treat COVID-19. These were available on the Amazon Associates Program.
• Musthavemom.com (United States) received a Warning Letter dated May 26 for website statements that certain products could prevent or treat COVID-19. These were available on the Amazon Associates Program.
• StayWell Copper Products (Fort Collins, CO) received a Warning Letter dated May 28 for statements on the company website and social media that certain products could prevent or treat COVID-19.
• Natural Solutions Foundation (Newton, NJ) received a Warning Letter dated May 19 for statements on websites that the company’s line of “Dr. Rima RecommendsTM Nano Silver 10 PPM” products could prevent or treat COVID-19.
• Dr. Sherrill Sellman (Burlington, MA) received a Warning Letter dated June 1 for statements on the company’s websites and social media that certain silver products could prevent or treat COVID-19.
• organic-beauty-recipes.com (United States) received a Warning Letter dated June 8 for marketing essential oil products as preventing or treating COVID-19.
• www.outoftheboxremedies.com (Modiin, Israel) received a Warning Letter dated June 10 for marketing products on websites and social media as preventing or treating COVID-19.
• EUCYT Laboratories LLC (Las Vegas, NV) received a Warning Letter dated June 4 for marketing an exosome product as a prevention or treatment for COVID-19. The company also manufactures cord blood products and the Letter also described statements that the company’s cord blood products could prevent or treat disease in general.
• FRS International, LLC (Boston, MA) received a Warning Letter dated June 15 for statements on the company’s website and social media that certain products could prevent or treat COVID-19.
• Sovereign Laboratories, LLC (Cottonwood, AZ) received a Warning Letter dated June 15 for statements on company websites that certain products could prevent or treat COVID-19.
• Sonrisa Family Dental dba www.mycovidtest19.com (Chicago, IL) received a Warning Letter dated June 15 for marketing unapproved kits to test for COVID-19.
• antibodiescheck.com (United Arab Emirates) received a Warning Letter dated June 15 for offering an unapproved COVID-19 test kit.
• Medakit Ltd (Hong Kong) received a Warning Letter dated June 10 for offering an unapproved COVID-19 test kit.
• Project 1600 Inc. (Amagansett, NY) received a Warning Letter dated June 18 for statements on the company website that products could prevent or treat COVID-19.
• North Isle Wellness Center (Miller Place, NY) received a Warning Letter dated June 19 for statements on the company website that its “Methylene Blue” products could prevent or treat COVID-19.
• KBMO Diagnostics, LLC (Hopedale, MA) received a Warning Letter dated June 17 for offering an unapproved COVID-19 test kit.
• Curativa Bay Corporation (Clearwater, FL) received a Warning Letter dated June 25 for statements that a topical product could prevent or treat COVID-19.
• Nuance Health, LLC (Ponte Vedra Beach, FL) received a Warning Letter dated June 26 for website and social media statements that its “Swype Shield” product could prevent or treat COVID-19.
• SuperHealthGuard and Loyal Great International Ltd. (Hong Kong) received a Warning Letter dated June 26 for statements that a Chinese medicine product could prevent or treat COVID-19.
• Global Commodities Corp. (Soquel, CA) received a Warning Letter dated June 30 for website statements that some products could prevent or treat COVID-19.
• Modern Allergy Management LLC dba Direct Med Solutions LLC (Milton, FL) received a Warning Letter dated June 17 for selling an unapproved COVID-19 test kit.

CGMP/FOOD/ PREPARED, PACKED OR HELD UNDER INSANITARY CONDITIONS/ADULTERATED

• Portland Sandwich Company (Portland, OR) received a Warning Letter dated April 3 for ready-to-eat sandwiches FDA determined were adulterated due to potential insanitary conditions during preparation.
• T & S Dairy (Winnsboro, TX) received a Warning Letter dated April 14 listing concerns that animals used in dairy operations held in conditions FDA characterized as so “inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”
• Quality Dairy Company (Lansing, MI) received a Warning Letter dated May 13 for a number of cleaning and sanitization issues. Notably, one FDA observer found a live German cockroach nymph in the facility.
• Iacofano’s Group LLC (Charleston, SC) received a Warning Letter dated May 28 for several observations, including potential cross-contamination of product with allergens.
• Raw Juicery, Inc. (Los Angeles, CA) received a Warning Letter dated June 11 as the company’s HACCP plan failed to identify the hazard of patulin.
• El Abuelito Cheese, Inc. (Paterson, NJ) received a Warning Letter dated June 4 for a number of deficiencies, including finds of Listeria pathogens in the facility where ready-to-eat cheese products are manufactured.

CGMP/FOOD FOR ANIMALS/PREPARED, PACKED OR HELD UNDER INSANITARY CONDITIONS/ADULTERATED

• Lea-Way Farms Inc. dba Blue Ridge Beef (Statesville, NC) received a Warning Letter dated June 26 for a number of deficiencies, many concerning raw materials, and failure to register the site under the FD&C Act.

ACIFIED FOODS/EMERGENCY PERMIT CONTROL/ADULTERATED/MISBRANDED

• Allied Food Products Inc (Linden, NJ) received a Warning Letter dated April 14