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  5. Wholly Liquid Nutritional Supplements LLC - 617324 - 12/09/2021
  1. Warning Letters

WARNING LETTER

Wholly Liquid Nutritional Supplements LLC MARCS-CMS 617324 —


Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages

Recipient:
Recipient Name
Dr. Douglas A. Wine
Recipient Title
Registered Agent
Wholly Liquid Nutritional Supplements LLC

5R Merrill Industrial Drive, 2nd Floor
Hampton, NH 03842
United States

Issuing Office:
Office of Human and Animal Food Operations East – Division 1

United States


WARNING LETTER
CMS# 617324

Austin A. Wine
Manager
Wholly Liquid Nutritional Supplements LLC
5R Merrill Industrial Drive, 2nd Floor
Hampton, NH 03842

Dear Dr. Douglas Wine and Mr. Austin Wine:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.whollyliquid.com/ in November and December 2021 and has determined that you take orders there for the products SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver. We have also reviewed your social media website at https://www.facebook.com/whollyliquid/, which directs consumers to your website at https://www.whollyliquid.com/ to purchase your products. The claims on your website and social media site establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of website claims that establish that your products are intended for use as drugs include:

SpiroLaze

• On the SpiroLaze page on your website (https://www.whollyliquid.com/products/spirolaze):
o “Supports the Elimination of Lyme Bacteria”
o “Lyme Disease”
o “Antimicrobial”
o “SpiroLaze Supports the Elimination of Lyme Bacteria.”
o “Benefits include anti-inflammatory properties, . . . speeding the physical process of healing, help for osteoporosis and osteopenia, . . . helps rid the body of chronic Lyme disease, Candida overgrowth, and helps Jaundice.”

• On your Facebook page (https://www.facebook.com /whollyliquid/), an October 26, 2020, post states in part: “SpiroLaze . . . helps rid the body of things like jaundice, Lyme disease, and candida. All 3 tinctures are being used at Lyme Laser Centers in their Lyme disease program!”

BioLaze:

• On the BioLaze page on your website (https://www.whollyliquid.com/products/biolaze):
o “Lyme Disease”
o “Antimicrobial”
o “BioLaze is useful for its anti-microbial properties which help neutralize Lyme neuro and biotoxins.”
o “Benefits include . . . the elimination of any bio or neurotoxins from any bacteria, mold, or other sources as well. It is an anti-inflammatory and anti-microbial formula that helps ulcers, stomach problems, mouth infections, diabetes, and high blood pressure, with antibiotic properties.”

• On your Facebook page (https://www.facebook.com /whollyliquid/):
o An October 26, 2020, post states in part, “BioLaze is an antimicrobial which helps to neutralize biotoxins.”
o A June 30, 2021, post states in part, “BioLaze is useful for its anti-microbial properties which help neutralize Lyme neuro and biotoxins.”

LiquiLaurin:
• On the LiquiLaurin page on your website (https://www.whollyliquid.com/product/liquilaurin):
o “Fights Molds, Bacteria & Viruses”
o “Antimicrobial”
o “Lyme Disease”
o “Fights Molds, Bacteria & Viruses! LiquiLaurin™ is a liquid form of Monolaurin that fights bacteria, viruses, mold, and more. It also is capable of deteriorating biofilms which are present in Lyme disease, Candida, and other micro-organisms. LiquiLaurin™ is . . . powerful enough to help fight pathogens from Epstein–Barr Virus to urinary tract infections!”
o “In addition to fighting bacteria, viruses, fungi, mold, and breaking down ‘Biofilms’, Monolaurin, the main ingredient in LiquiLaurin™, has been shown effective in vitro and in vivo against a number of bacteria (both Gram Positive and Gram Negative), yeast, and protozoa by disintegrating the cell membrane and blocking signal transduction and in vitro to kill a wide range of DNA and RNA enveloped viruses by breaking down the outer lipid membrane.”
o “LiquiLaurin™ is known to attack these pathogens including, but are not limited to:
▪ Borrelia burgdorferi and Borrelia garinii (the bacteria which cause Lyme disease in humans)
▪ Candida albicans (commonly associated with urinary tract and yeast infections)
▪ Chlamydia
▪ Epstein–Barr Virus (EBV)
▪ E. Coli (responsible for food poisoning)
▪ Clostridium difficile (C. difficile)
▪ Herpes Simplex 1 (HSV-1)
▪ Herpes Simplex 2 (HSV-2)
▪ …
▪ Helicobacter pylori (H. Pylori)
▪ Cytomegalovirus
▪ Entamoeba histolytica (causes stomach and intestinal problems)
▪ …
▪ Giardia lamblia (causes diarrhea)
▪ Measles
▪ Saccharomyces cerevisiae
▪ …
▪ Staphylococcus aureus (Staph infection and MRSA)
▪ Enterococcus faecalis (urinary tract infections)
▪ Streptococcus agalactiae (also known as Group B streptococcus or GBS)”

• On your Facebook page (https://www.facebook.com /whollyliquid/), a March 20, 2020, post states in part: “Fight bacteria, viruses and more with #LiquiLaurin! This formula is . . . powerful enough to help fight pathogens from viruses all the way to urinary tract infections.”

VIT-B12:

• On the Vit-B12 page on your website (https://www.whollyliquid.com/products/vit-b12/): “It helps with nerve damage in the hands or feet, sleep disorders, depression, mental disorders, inflammatory bowel disease, diarrhea, asthma, allergies, Lyme disease, and ringing in the ears.”

DeStress:

• On the DeStress page on your website (https://www.whollyliquid.com/product/de-stress/): “Benefits to the body are anti-inflammatory properties . . . help with sexual dysfunction . . . relief from congestion, and other symptoms of respiratory disorders. It also lowers blood sugar, protects against diabetes, and includes the ability to control blood glucose levels. . . . Relieves . . . depression/anxiety symptoms, helps the body to fight cancer and other degeneration.”
• On your Facebook page (https://www.facebook.com /whollyliquid/), a May 15, 2020, post states in part: “This Adrenal formula [DeStress] helps to relieve . . . depression and anxiety . . ..”

Omega Plus:

• On the Omega Plus page on your website (https://www.whollyliquid.com/product/omega-plus/):
o “Fight Depression and Anxiety”
o “Improve Risk Factors for Heart Disease”
o “Reduce Symptoms of ADHD”
o “Help Prevent Cancer”
o “Fight Age-Related Mental Decline and Alzheimer’s Disease”
o “Improve Mental Disorders”
o “Fight Autoimmune Diseases”
o “Fight Inflammation and pain”
o “Reduce Asthma”

• On your Facebook page (https://www.facebook.com/whollyliquid/):
o A May 13, 2020, post states in part: “OmegaPlus . . . reducing risk of heart disease, fighting inflammation and pain . . .”
o A April 20, 2020, post states in part: “OMEGA PLUS . . . adds Essential Fatty Acids which have . . . benefits like fighting depression and anxiety, regulating blood pressure . . ..”

Ionized Silver:

• On the Ionized Silver page on your website (https://www.whollyliquid.com/product/silver):
o “Silver Fights Bacteria & Viruses”
o “Silver is a mineral with an amazing potential to help in the fight against bacteria and viruses among other health issues.”
o “It is believed that Silver supports the immune system by neutralizing bacteria, pathogens, viruses, and even some eye infections.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. 331(a)].

This letter is not intended to be an all‐inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

cc:

Dr. Douglas A. Wine
Resident Agent
The Lyme Laser Center of Greater Boston LLC
5R Merrill Industrial Drive, 2nd Floor
Hampton, NH 03842

Mr. Austin A. Wine
Manager
The Lyme Laser Center of Greater Boston LLC
5R Merrill Industrial Drive, 2nd Floor
Hampton, NH 03842

 
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