WARNING LETTER
Bea Lydecker’s Naturals, Inc.
MARCS-CMS 616439 —
February 09, 2022
Delivery Method:
Overnight Delivery
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Beatrice C. Lydecker-Hayford
Recipient Title
Owner
Bea Lydecker’s Naturals, Inc.
15443 South LaTourette Road
Oregon City
,
OR
97045
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
February 9, 2022
In reply, refer to CMS 616439
WARNING LETTER
Dear Ms. Lydecker-Hayford:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement distributing facility, located at 15443 South LaTourette Road, Oregon City, Oregon, on June 6, 11, and 24, 2021. FDA reviewed your product labels and labeling collected during the inspection, including the Bea Lydecker’s Naturals, Inc. Product Catalog, Philosophy of Bea Lydecker product catalog, and Living Free Herbal Extract brochure; as well as your website at the Internet address www.bealydecker.com in February 2022. The claims on your labels, catalogs, brochure, and website establish that your Enzymes Plus, Artho Flex, Herbal Extract, Herbal Compound, Heart / Blood Vessel, Immune, Nerve & Muscle Plus Cetyl-Myristoleate, Lung & Joint Congestion, Liquid Zeolite, Copper, Silver, Magnesium, Zinc, Adult Extra, Equine Calmer, Equine Artho-Flex, Calmer, and CBD Oil Procana Spectrum products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)] 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 Act.
Additionally, your products Adult Extra, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Enzymes Plus, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
Further, we observed that your products Herbal Extract, Herbal Compound, and Immune are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
1
in people.
We also observed that you promote your CBD Oil Procana Spectrum as a product containing cannabidiol (CBD) for humans and animals.
You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
You can find specific information about how FDA regulates CBD at
www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
Unapproved New and Misbranded Drugs
During the inspection, we collected labels and labeling related to your dietary supplements, including your Bea Lydecker’s Naturals, Inc. Product Catalog and Herbal Extract brochure, which you distribute with new orders of your products. In addition, we reviewed the product catalog, product pages, and newsletters posted on your website, www.bealydecker.com, in February 2022. Your website allows for your products to be added to an electronic shopping cart. Upon checkout, your cart then directs customers to contact your company to purchase products. You informed our investigators that customers may order products over the telephone, or through email or text.
The claims on your labels and labeling, including your website, product catalogs, Herbal Extract brochure, and newsletters provide evidence that your products Enzymes Plus, Artho Flex, Herbal Extract, Herbal Compound, Heart / Blood Vessel, Immune, Nerve & Muscle Plus Cetyl-Myristoleate, Lung & Joint Congestion, Liquid Zeolite, Copper, Silver, Magnesium, Zinc, Adult Extra, and CBD Oil Procana Spectrum are intended for use as drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of claims on your labels, catalog, brochure, and website that provide evidence your products are intended for use as drugs include, but are not limited to, the following:
Enzymes Plus
On the Enzymes Plus product label:
“The ENZYME PLUS formula uses specialized enzymes that break down excess protein such as SCAR TISSUE and FIBRIN in the blood vessels and internal organs, removes the protective protein coating on tumors, cancers and parasites, renders viruses and bacteria inert and reduces the immune systems ability to attack the body in auto immune diseases such as MS, LUPUS and RHEUMATOID ARTHRITIS. Combined with Magnesium (a natural blood thinner) and B-6, they help lower BLOOD PRESSURE, CHOLESTEROL and dissolve BLOOD CLOTS, thus aiding in the prevention and treatment of ARTHEROSCLEROSIS, STROKES AND HEART DISEASE … and DIABETES, while alleviating ANXIETY, CONFUSION, EPILEPSY, MIGRAINES, and INSOMNIA.”
On the Enzymes Plus product page on your website, www.bealydecker.com:
“This formula uses specialized enzymes to break down excess protein on scar tissue and fibrin in the blood vessels and internal organs; removes the protective protein coating on tumors, cancers, and parasites; renders viruses and bacteria inert; reduces the immune systems ability to attack the body in auto immune diseases such as MS, Lupus and Rheumatoid Arthritis. Combined with Magnesium and B-6 to help lower Blood Pressure, Cholesterol and dissolve blood clots, thus aiding in the prevention and treatment of Atherosclerosis, Strokes and Heart Disease. It … aids in reducing anxiety, confusion, epilepsy, migraines and insomnia.”
From the product catalog on your website, www.bealydecker.com:
On page 13: “Enzymes Plus: … This formula uses specialized enzymes that helps the body break down excess protein on scar tissue and fibrin in the blood vessels and internal organs. It also seems to help remove the protective protein coating on tumors, cancers, and parasites, helping the body render viruses and bacteria inert. This blend is combined with Magnesium (a natural blood thinner) and B-6 that the body uses to help lower Blood Pressure and dissolve blood clots.”
Artho Flex
On the Artho Flex product label:
“LIVING FREE ARTHO-FLEX consists of Cetyl-myristoleate, … It was developed by Harry W. Diehl, a researcher who was commissioned to find a cure for arthritis.”
“Suggested dosage: 1 or 2 capsules, three times a day until arthritic pain is relieved.”
On the Artho Flex product page on your website, www.bealydecker.com:
“… cetyl-myristoleate [an ingredient in Artho Flex] … seems to eradicate any kind of chronic pain, especially arthritic pain, along with its accompanying swelling, fever, and joint deformity, no matter what form the arthritis takes.”
“In the approximate 1% of our clients who were not cleared of arthritis, I believe it was because they had bone on bone due to a loss of synovial fluid to cushion the joint. The other problem could be coming from Mercury that has settled in the joints from Dental amalgams or from medications, thus we recommend the Zeolite to clear heavy metals while treating arthritis. Since its discovery, there have been NO ADVERSE REACTIONS in mammals.”
From the product catalog on your website, www.bealydecker.com:
On page 11: “ARTHO FLEX: Cetyl-Myristoleate [an ingredient in Artho Flex] was developed by Harry W. Diehl, … For 60 years he researched a cure for arthritis, accomplishing his goal 20 years ago, … [Cetyl-Myristoleate] seems to eradicate any kind of chronic pain, especially arthritic pain, along with its accompanying swelling, fever, and joint deformity, no matter what form arthritis takes. In the approximate 1% of our clients who were not cleared of arthritis, I believe it was because they had bone on bone due to a loss of synovial fluid to cushion the joint. The other problem could be coming from Mercury that has settled in the joints from Dental amalgams or from medications, thus we recommend the Zeolite to clear heavy metals while treating arthritis. Since its discovery, there have been NO ADVERSE REACTIONS in mammals.”
Herbal Extract
On the Herbal Extract product page on your website, www.bealydecker.com:
“Concentrated liquid herbal blend proven to be VERY effective in fighting viruses: colds, flu, Ebola, fungus (ex: Valley Fever), cancer, dissolving tumors, sebaceous cysts.”
From the Living Free Herbal Extract brochure, which you ship with new orders of your Herbal Extract product:
“YOU DON’T HAVE TO FEAR COVID 19 IF YOU HAVE THE HERBAL EXTRACT ON HAND. IT KILLS ANY VIRUS NO MATTER WHAT IT IS. ANY DOCTOR OR HEALTH CARE WORKER SHOULD KEEP THIS PRODUCT ON HAND. We have found that with the average adult, four drops a day in some juice, yogurt or milk (not water) will kill the virus in about four to 7 days. For little children we have seen all kinds of flu and colds go away in about 4 days on two drops a day. You do not take it as a preventive, but if it hits, it is safe and VERY Effective.”
“HYPERICUM PERFORATUM (ST. JOHNSWART) [an ingredient in your Herbal Extract product]: alterative, anti- Inflammatory, antispasmodic, astringent, expectorant, nervine, vulnerary. Used to treat insomnia and other nervous conditions, colic, anemia, headache, jaundice, congestion, … wounds and has been used as a pain-relieving sedative.”
“RUBUS VILLOSUS (BLACKBERRY) [an ingredient in your Herbal Extract product]: astringent, diuretic, expectorant, hemostatic and tonic. Used to counteract dysentery, bleeding, enteritis, leucorrhea, anemia, to regulate menses and is a premier diarrhea remedy.”
“SANGUINARIA CANADENSIS (BLOODROOT) [an ingredient in your Herbal Extract product]: alterative, diuretic, expectorant, emmenagogue, febrifuge, sedative, stimulant, tonic. It is emetic in large doses. Used internally to treat respiratory tract infections, sinus congestion, laryngitis, sore throat, asthma, croup, and pneumonia.”
“IMPATIENS PALIDA (JEWELWEED) [an ingredient in your Herbal Extract product]: cathartic, diuretic, emetic. Internally used to treat Jaundice, hepatitis, ascites and stomach conditions.”
“HYDRASTIS CANADENSIS (GOLDENSEAL) [an ingredient in your Herbal Extract product]: alterative, antibiotic, anti-inflammatory, antiperiodic, antiseptic, astringent, diuretic, laxative, tonic. A strong antibiotic, it is used to treat flu, fevers, giardia and any form of infection. It cleanses excessive mucous … inhibits excessive bleeding and is a stimulant to uterine muscles.”
“FERULA GALBANIFLUA (GALBANUM) [an ingredient in your Herbal Extract product]: aromatic, antispasmodic, carminative, digestant, expectorant, laxative, sedative. Having much effect on the respiratory system, it is used to treat asthma, bronchitis and whooping cough as well as digestion problems, gas, croup, and colic.”
“FUMARIA OFFICINALIS (FUMITORY) [an ingredient in your Herbal Extract product]: alternative, cholagogue, diuretic, laxative, stomachic, tonic. Used for liver and gallbladder ailments as well as constipation, stomach disorders, eczema, dermatitis, exanthema and scabies.”
“FRASERA CAROLINENSIS (ELKWEED) [an ingredient in your Herbal Extract product]: cholagogue, febrifuge, refrigerant, stomachic; tonic. Used for indigestion, stomachache, heartburn and catarrhal gastritis and as a bloodbuilder due to its tendency to raise the white blood cell count.”
“ALLICIN (GARLIC) [an ingredient in your Herbal Extract product]: anthelmintic, antiparasitic, antispasmodic, … diuretic, expectorant, febrifuge. The volatile oil of the bulb has strong bactericidal action … It has been used to treat liver, gall bladder and intestinal problems, infections, blood pressure and circulation disorders as well as giardia, staphylococcus, streptococcus, and salmonella bacteria and is effective against bacteria resistant to antibiotic drugs.”
From the product catalog on your website, www.bealydecker.com:
On pages 3 – 4: “I knew something was definitely wrong, but it was not until the tumors filled my lungs, stomach and covered my head, did we get the diagnosis through a biopsy. I learned that I had Epstein Bar/Chronic Fatigue. I was covered with Candida rashes and had all the symptoms of Fibromyalgia such as the pain points and muscle weakness ... When allopathic medicine gave me up to die, I began to research the causes for my diseases and how they could be corrected. Through the use of the Living Free Herbal Extract and the other blends I have developed ... I am completely well ...”
On page 15: “HERBAL EXTRACT: ... It has proven to be VERY effective in fighting any kind of virus, cancer and in dissolving tumors of any kind including sebaceous cysts.”
From the Summer Newsletter 2020 on your website, www.bealydecker.com:
“T cells are extremely important in getting well. Even with the Covid 19 virus, I heard doctors saying how some people can’t develop immunity to Covid because they don’t have enough T Cells to fight the virus ... My Immune formula does restore them [T cells] and along with the Herbal Extract that kills Viruses, people are getting well from AIDS.”
From the Update Spring 2021 newsletter on your website www.bealydecker.com:
“Why not use the antibodies of people who have already recovered from Covid ? … I am not afraid of this or any virus as I know how my Herbal Extract and herbal Compound have already saved my life when I contracted Dengue Fever (similar to Ebola) during a visit to Central America. An acquaintance went fishing with his friends to Costa Rica and they all got sick with it but not him! He took his Herbal Extract and had NO problems. Keep it on hand and you will be fine. I’ve had many others get well from Covid 19 no matter how sick they got. Keep it on hand and you should be fine.”
Herbal Compound
From the Greetings Spring 2021 newsletter on your website, www.bealydecker.com:
“To ward off or kill this new strain of Corona I am advising everyone to increase their intake to two capsules per day [of Herbal Compound] or if on the liquid, take 6 to 7 drops a day.”
Heart / Blood Vessel
(also referred to as Heart & Blood Vessel and Heart and Blood Vessel)
On the Heart & Blood Vessel product page on your website, www.bealydecker.com:
“Heart & Blood Vessel along with the Liver and Immune formulas seems to reduce or clear up cardiomyopathy, regulates heart rate for anyone with irregular heartbeats, such as Premature Atrial Contractions and Atrial Fibrillations, but especially for those born with extra nerves to the heart. This product seems to enable them to live normal, active lives. In many people, it seems to aid in regulating and normalizing blood pressure and cholesterol.”
From the product catalog on your website, www.bealydecker.com:
On page 14: “HEART AND BLOOD VESSEL: ... HBV along with the Liver and Immune formulas seems to reduce or clear up Cardiomyopathy, HBV also regulates heart rate for anyone with irregular heartbeats, but especially for those born with extra nerves to the heart, enabling them to live normal, active lives. In many people, it seems to aid in regulating and normalizing blood pressure and cholesterol.”
Immune
On the Immune product page on your website, www.bealydecker.com:
“Rebuilds the thymus gland’s ability to produce absolute CD4 T cells needed to keep cancer, tumors, TB [Tuberculosis], skin eruptions and AIDS from recurring. In building the immune system you are preventing colds and many other diseases.”
From the product catalog on your website, www.bealydecker.com:
On page 17: “IMMUNE: ... Rebuilds the thymus gland’s ability to produce absolute CD4 T cells needed to keep cancer, tumors, TB [Tuberculosis], skin eruptions and AIDS from recurring. In building the immune system you are preventing colds and many other diseases.”
From the Summer Newsletter 2020 on your website, www.bealydecker.com:
“Even with the Covid 19 virus, I heard doctors saying how some people can’t develop immunity to Covid because they don’t have enough T Cells to fight the virus ... My Immune formula does restore them and along with the Herbal Extract that kills Viruses, people are getting well from AIDS.”
Nerve & Muscle Plus Cetyl-Myristoleate
On the Nerve & Muscle Plus Cetyl-Myristoleate product page on your website, www.bealydecker.com:
“Helps alleviate numbness from feet and hands. Clears most chronic pain, even the more severe headaches like migraines that are not hormone related, if taken at the beginning of the headache. This formula can be combined with Artho Flex to clear the arthritis faster and help sooth some of the arthritis related pain. We recommend taking MSM ... at pretty high doses to remove the inflammation connected to arthritis and inflammatory artery disease.”
From the product catalog on your website, www.bealydecker.com:
On page 19: “NERVE & MUSCLE PLUS CETYLMYRISTOLEATE ... Helps alleviate numbness from feet and hands and clears most chronic pain, even the more severe headaches like Migraines that are not hormone related, if taken at the beginning of the headache. This formula is combined with Artho Flex to clear the arthritis faster and help sooth some of the arthritis related pain. We recommend taking MSM ... at pretty high doses to remove the inflammation connected to arthritis and inflammatory artery disease.”
Lung & Joint Congestion
(also referred to as Lung & Joint and Lung & Joint Formula)
On the Lung & Joint product page on your website, www.bealydecker.com:
“Mostly used by asthmatics, emphysema, or anyone suffering from lung congestion. ... it opens the bronchial tubes ... We call this product L&J because the lungs affect the ability of the body to eliminate excessive fluid buildup thus will leave the fluids in the joints. The lymph glands dump through the lungs as well as through the kidneys. ... L & J opens the alveoli because the Lobelia & mullein relax the pressure & lung spasms of bleeders, asthmatics ...”
From the product catalog on your website, www.bealydecker.com:
On page 18: “LUNG AND JOINT ... Mostly used by asthmatics, emphysema (opens lungs enough so they can sometimes get out without their oxygen), or anyone suffering from lung congestion ... [it] opens the bronchial tubes ... We call this product lung and joint because the lungs affect the ability of the body to eliminate excessive fluid buildup thus will leave the fluids in the joints. The lymph glands dump through the lungs as well as through the kidneys. ... L & J opens the alveoli because the Lobelia and mullein relax the pressure and lung spasms of bleeders, asthmatics ...”
From the Holiday Greetings 2019 newsletter on your website, www.bealydecker.com:
“We are having wonderful results with the Lung and Joint formula because it appears to open the alveoli of in the lungs. It allows people with COPD [Chronic Obstructive Pulmonary Disease] to breath and releases the spasms in the lungs of asthmatics. I developed this product with my sister in mind because her asthma was so severe ... She was never more than a few feet away from her atomizer, but with the Lung and Joint formula, she was able to go places for hours without using the atomizer. When we tried it with COPD clients, they were able to go places and not have to use their oxygen so often.”
From the Living Free Herbal Extract brochure, shipped with customer orders of Herbal Extract:
“If you are having difficulty breathing, the Lung and Joint formula naturally opens the Alveoli to allow you to breathe more freely, It also contains expectorants.”
Liquid Zeolite
On the Zeolite - Liquid product page on your website, www.bealydecker.com:
“Zeolite helps remove heavy metals from the cells of the body by trapping them and other toxins in its honeycomb like framework of cavities and channels, ... Some experience ... a lessening of bi polar or schizophrenia symptoms, autistic children are calmer and more focused, relief from shingles ... This product is vital for Alzheimer patients as it helps remove the aluminum and mercury affecting the brain.”
From the product catalog on your website, www.bealydecker.com:
On page 20 – 21: “LIQUID ZEOLITE: ... Zeolite removes all heavy metals from the cells of the body by trapping them and other toxins in its honeycomb like framework of cavities and channels, ... Some experience ... a lessening of bi polar or schizophrenia symptoms, autistic children are calmer and more focused, relief from shingles ... This product is vital for Alzheimer patients as it helps remove the aluminum and mercury affecting the brain.”
Copper
On the Copper product page on your website, www.bealydecker.com:
“Kills parasites.”
From the product catalog on your website, www.bealydecker.com:
On page 22: “Copper---Kills parasites”
Magnesium
On the Magnesium product page on your website, www.bealydecker.com:
“Prevents migraines, bone loss, ... and helps shrink tumors.”
From the product catalog on your website, www.bealydecker.com:
On page 22: “Magnesium---Prevents migraines, bone loss, ... and helps shrink tumors.”
Silver
On the Silver product page on your website, www.bealydecker.com:
“Natural antibiotic.”
From the product catalog on your website, www.bealydecker.com:
On page 22: “... silver--- ... natural antibiotics”
Zinc
On the Zinc product page on your website, www.bealydecker.com:
“Natural anti-viral ...”
From the product on your website, www.bealydecker.com:
On page 22: “Zinc---Natural anti-viral ...”
Adult Extra
On the Adult Extra product page on your website, www.bealydecker.com:
“Recommended for: anyone recovering from illness ...”
From the product catalog on your website, www.bealydecker.com:
On page 10: “Adult extra: ... Recommended for anyone recovering from illness ...”
CBD Oil Procana Spectrum
From the product catalog on your website, www.bealydecker.com:
On page 12: “CBD OIL Procana Spectrum ... helps relieve minor and some major pain ... Seems to aid in reducing inflammation.”
Your products Enzymes Plus, Artho Flex, Herbal Extract, Herbal Compound, Heart / Blood Vessel, Immune, Nerve & Muscle Plus Cetyl-Myristoleate, Lung & Joint Congestion, Liquid Zeolite, Copper, Silver, Magnesium, Zinc, Adult Extra, and CBD Oil Procana Spectrum are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), § 355(a)]. FDA approves a new drug based on scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the 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 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 products Enzymes Plus, Herbal Extract, Herbal Compound, Heart / Blood Vessel, Immune, Liquid Zeolite, Lung & Joint Congestion and Magnesium are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Enzymes Plus, Herbal Extract, Herbal Compound, Heart / Blood Vessel, Immune, Liquid Zeolite, Lung & Joint Congestion, and Magnesium products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the 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 Act [21 U.S.C. § 331(a)].
Unapproved New Animal Drugs
Based on our review of your website www.bealydecker.com, in February 2022, your Equine Calmer, Equine Artho-Flex, Calmer, Herbal Extract, Immune, Lung & Joint Congestion, Liquid Zeolite, and CBD Oil Procana Spectrum products are drugs under section 201(g)(1) of the Act, [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal.
Examples of claims observed on your website www.bealydecker.com that establish the intended use of these products as drugs include, but are not limited to, the following:
Equine Calmer
On the Equine Calmer product page on your website, www.bealydecker.com:
“Useful for all larger animals and birds. ... Helps heal the nervous system and calms them in anxiety situations. Also effective as a natural anti-spasmodic used by horses for shows, gaming, and racing without hampering performance. No adverse side effect observed and generally passes drug testing.”
From the Holiday Greetings 2019 newsletter on your website, www.bealydecker.com:
“Some horses have trouble getting so worked up before a barrel race that they can almost not get through the starting gate, but the Equine Calmer is very effective in helping them mentally calm down. I have had some thoroughbred racehorse trainers use this product in the night feeding with young horses first coming to the track for training because it helps calm their fears, relaxing them so they rest better. Sometimes when horses run hard they “tie up” with muscle spasms. The Equine Calmers usually relieves that too.”
Equine Artho-Flex
On the Equine Artho-Flex product page on your website, www.bealydecker.com:
“Helps alleviate most chronic pain; one to three pounds will usually clear arthritis in most animals, especially horses.”
Calmer
On the Calmer product page on your website, www.bealydecker.com:
“Effective, safe product for any kind of stress, anxiety or fear such as travel, new places, training, 4th of July and thunderstorms.”
Herbal Extract
On the Herbal Extract product page on your website, www.bealydecker.com:
“Concentrated liquid herbal blend proven to be VERY effective in fighting viruses: ... Effective in killing Parvo & Kennel Cough viruses.”
From the product catalog on your website, www.bealydecker.com:
On page 15: “HERBAL EXTRACT: ... It works effectively in killing the Parvo virus and the Kennel Cough viruses.”
Immune
From the Summer Newsletter 2020 on your website, www.bealydecker.com:
“Is your dog suffering from itchy skin and loss of hair? The Immune formula corrects that, brings back a shiny full coat and builds their immune systems in about three months. Also restores low thyroid in animals and people in about the same amount of time.”
Lung & Joint Congestion
(also referred to as Lung & Joint and Lung & Joint Formula)
On the Lung & Joint product page on your website, www.bealydecker.com:
“The L&J formula will usually stop bleeding in race or performance horses that are called “bleeders”. L & J opens the alveoli because the Lobelia & mullein relax the pressure & lung spasms of bleeders, asthmatics & horses with heaves.”
From the Holiday Greetings 2019 newsletter on your website, www.bealydecker.com:
“When we tried the Lung and Joint product on horses suffering from heaves, a form of equine asthma, the response was PHENOMINAL [sic]. We are seeing horses that could not stop coughing and no longer able to work, back out barrel racing and performing, living a full life with their owners. It is only used when they are having difficulties, and takes about 15 minutes to work. So far there has been no adverse side effects, so appears to be safe. We have even seen horses that are “bleeders” when they run, have little or no problems anymore. It is legal to use, even in racehorses.”
Liquid Zeolite
On the Liquid Zeolite product page on your website, www.bealydecker.com:
“Zeolite helps remove heavy metals from the cells of the body by trapping them and other toxins in its honeycomb like framework of cavities and channels, helps balance pH levels, and is 100 percent natural and safe for long term use. ... even animals that are sick, do much better.”
CBD Oil Procana Spectrum
From the product catalog on your website, www.bealydecker.com:
On page 12: “CBD OIL Procana Spectrum ... helps relieve minor and some major pain ... Good for people and animals. ... Seems to aid in reducing inflammation.”
Your Equine Calmer, Equine Artho-Flex, Calmer, Herbal Extract, Immune, Lung & Joint Congestion, Liquid Zeolite, and CBD Oil Procana Spectrum products are “new animal drugs” under section 201(v) of the Act [21 U.S.C. § 321(v)] because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, new animal drugs must have an approved new animal drug application, conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the Act [21 U.S.C. § 360b, § 360ccc, § 360ccc-1], respectively.
Your Equine Calmer, Equine Artho-Flex, Calmer, Herbal Extract, Immune, Lung & Joint Congestion, Liquid Zeolite, and CBD Oil Procana Spectrum products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. § 360b, § 360ccc, § 360ccc-1]. New animal drugs that lack the required approval or index listing are "unsafe" and "adulterated" under sections 512(a) and 501(a)(5) of the Act [21 U.S.C. § 360b(a), § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of adulterated drugs is prohibited under section 301(a) of the Act, [21 U.S.C. § 331(a)].
Misbranded Dietary Supplements
Even if your products Adult Extra, Herbal Compound, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Enzymes Plus, Immune, Heart / Blood Vessel, Lung & Joint Congestion did not have therapeutic claims that make them unapproved new drugs, your dietary supplement products that you distribute under your “Living Free” brand would be misbranded under section 403 of the Act [21 U.S.C. § 343]:
1. Your Adult Extra product is misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act [21 U.S.C. § 343(a)(1), § 321(n)] in that the label of the product with added iron, fails to bear the required warning statement, as required per 21 CFR 101.17(e).
2. Your Adult Extra, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Enzymes Plus, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size is not declared or is incorrectly declared on the labels. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2.
3. Your Adult Extra, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Enzymes Plus, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the labels fail to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).
4. Your Adult Extra, Herbal Compound, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
a. Your Adult Extra, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are manufactured into capsules, but the product labels fail to list the ingredients used to form the capsules.
b. Your Adult Extra product label declares the dietary ingredients P.A.B.A. and Biozyme but these are not the common or usual names for these dietary ingredients.
c. Your Adult Extra, Herbal Compound, Nerve & Muscle, and Nerve & Muscle Plus Cetyl-Myristoleate product labels declare trace mineral complex, but the labels fail to list the components of the complex. Furthermore, your Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, and Immune product labels declare enzyme complex but fail to list the components of the complex.
d. Your Adult Extra product label declares collagen, kidney, liver, heart, pancreas, and thymus. Your Digestion product label declares adrenal and pancreas. Your Nerve & Muscle and Nerve & Muscle Plus Cetyl-Myristoleate product labels declare collagen and thymus. Your Immune product label declares thymus, collagen, liver, kidney, heart, pancreas, and adrenal. Your Heart / Blood Vessel product label declares heart and collagen. Your Liver / Gall Bladder product label declares liver and kidney, and your Lung & Joint Congestion product label declares lung and collagen, but the label fails to identify the source of these ingredients, as required by 21 CFR 101.36(d) and 21 CFR 101.4(g).
e. Your Digestion and Immune product labels declare acidophilus, but this is not the common or usual name for this dietary ingredient. The label must state the complete Latin binomial name.
f. Your Liver / Gall Bladder product label declares stiklewort, but this is not a standardized common name noted in Herbs of Commerce.
5. Your Adult Extra, Immune, Nerve & Muscle Plus Cetyl-Myristoleate, Lung & Joint Congestion, and Heart / Blood Vessel products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the product label fails to correctly declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7. Specifically:
a. Your Adult Extra 500 capsules, Nerve & Muscle Plus Cetyl-Myristoleate 500 capsules, and Heart / Blood Vessel 100 capsules product labels fail to present the net quantity of contents statement in letters and numerals in a type size established in relationship to the area of the principal display panel of the package and is not uniform for all packages of substantially the same size, as required under 21 CFR 101.7(i). Specifically, the net contents statement bears the numeral 5 handwritten over the typewritten 1.
b. Your Immune 1 pound and Lung & Joint Congestion product labels declare the net quantity of contents as 1 pound but fail to use the term “net weight”, as required by 21 CFR 101.7(j)(2). Furthermore, these labels fail to express the net quantity of contents in metric units, as required by section 4(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. § 1453(a)(2)].
6. Your Adult Extra, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Artho Flex, Enzymes Plus, Herbal Compound, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36. For example:
a. Your product labels fail to present nutrition information in the nutrition label using the title “Supplement Facts” and other format requirements outlined in 21 CFR 101.36(e).
b. Your product labels fail to place the subheading “Serving Size” under the heading “Supplement Facts”, as required by 21 CFR 101.36(b)(1)(i) and fail to place the subheading “Servings Per Container” under the subheading “Serving Size”, as required by 21 CFR 101.36(b)(1)(ii), except that this information need not be provided when it is stated in the net quantity of contents declaration.
c. Your product labels fail to declare the (b)(2)-dietary ingredients and (b)(3)-dietary ingredients in the order and format prescribed in 21 CFR 101.36 which requires the (b)(2)-ingredients to be listed first followed by a heavy bar and then the (b)(3)-dietary ingredients. Furthermore, your Enzymes Plus product label bears the dietary ingredient nattokinase handwritten below the ingredients statement, but nattokinase and its quantitative amount per serving should be located with and presented in the same format as the (b)(3)-dietary ingredients.
d. Your product labels fail to declare the % Daily Values for each (b)(2)-dietary ingredient, as required by 21 CFR 101.36(b)(2)(iii) and fail to state “Daily Value not established” for each (b)(3)-dietary ingredient, as required by 21 CFR 101.36(b)(3)(iv). Furthermore, for your Adult Extra product labels, there is no provision for use of the term “RDA” in the Supplement Facts label; it appears that the amounts listed under that term are the quantitative amounts per four capsules. In addition, your Adult Extra product label declares the %DV (as “%US”) for 5 mg of niacin as 100%, but the correct %DV is 25%. Likewise, the product label fails to correctly declare the %DV for manganese, chromium, molybdenum, and selenium.
e. Your Adult Extra and Enzymes Plus product labels fail to express the quantitative amount of each dietary ingredient using a metric measure, as required by 21 CFR 101.36(b)(3)(ii)(A).
f. Your Adult Extra product label declares “Niacinamide” as a dietary ingredient, but this should be listed as the source of niacin in accordance with 21 CFR 101.36(d).
g. Your Adult Extra product label declares potassium with an amount of 46 mg per serving which is 1% of the Daily Value. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
h. Your Heart / Blood Vessel product label fails to declare the sources of calcium, magnesium, potassium, and vitamin E and your Lung & Joint Congestion product label fails to declare the sources of vitamin E and vitamin C. The source of each dietary ingredient must be designated on the label in accordance with 21 CFR 101.36(d).
7. Your Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 U.S.C. § 343(s)(2)(A)(ii)(I), § 343(q)(5)(F)] in that the label fails to include the quantitative amount by weight per serving of each dietary ingredient, as required by 21 CFR 101.36(b)(3).
8. Your Nerve & Muscle Plus Cetyl-Myristoleate product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label does not include a statement of identity as a “dietary supplement”, as required by 21 CFR 101.3(g).
9. Your Adult Extra, Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Herbal Compound, Immune, Liver / Gall Bladder, Heart / Blood Vessel, and Lung & Joint Congestion products are each misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1).
10. Your Digestion, Nerve & Muscle, Nerve & Muscle Plus Cetyl-Myristoleate, Enzymes Plus, Immune, Heart / Blood Vessel, Liver / Gall Bladder, Lung & Joint Congestion products are misbranded within the meaning of section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).
11. Your Heart / Blood Vessel product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains an ingredient identified as Siberian Ginseng (another common name for Eleutherococcus senticosus as noted in Herbs of Commerce). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
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 any violations 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 this matter may result in legal action including, without limitation, seizure and injunction.
We also have the following comment: your Digestion and Lung & Joint Congestion product labels misspell cayenne, your Herbal Compound misspells asafetida, your Immune (500 capsules) product label misspells echinacea, your Heart / Blood Vessel product label misspells L-carnitine, your Liver / Gall Bladder product label misspells chicory, and your Lung & Joint Congestion product label misspells lobelia.
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 actions 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 Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Glynn at 425-302-0411.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
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1
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Content current as of:
03/08/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages