Things We Cannot Say
We are posting these marketing guidelines, so you can understand why we cannot talk about certain things. This message contains content that we are not allowed to say or put into advertising media forms. While the Bio-Mat may be highly effective for many types of ailments, the United States Food and Drug Administration (FDA) has not determined the Bio-mat to be approved for treatment of those aliments.
We support the intent of these guidelines. Many products are promoted in the alternative health industry that have little efficacy. Claims are often made which have no basis in truth. On the other hand, there are several products out there that can dramatically change the health and vitality of an individual, but the costs to get approval for specific uses are prohibitive. We can tell you the Bio-Mat is effective for far more than what is approved by the FDA, but we cannot tell you what that is. That is our dilemma.
Richway & Fuji Bio Inc.,
1314 So. King St. Ste 520,
Honolulu, Hi 96814
July 17, 2015
Re: Marketing Guidelines
Aloha Richway Independent Sales Associate
Enclosed is our new Marketing Guidelines for Independent Sales Associates.
It explains most of the laws which apply to our products. This document is considered a “living document” and we will be updating it from time to time with new information. The latest version will always be available for download on our website.
This guide was made in response to the confusion many of us have in understanding the laws of the Food and Drug Administration and the Federal Trade Commission. The FDA has a history of going after companies in the health and wellness industry. The repercussions from them can be very severe, ranging from a mere warning to fines and the seizing of all merchandise. This has happened to many companies, so we decided to take a proactive approach to protect both our company and you,the Independent Sales Associate. Many of you may find the laws outlined in the guide strict, but please understand it is not us, it is the law. We too never realized how strict they were. But just like you, we too need to comply. As we learned of these laws,we found that many of our own marketing materials were flawed and need to be corrected. The latest versions of our materials have been posted on our website and are available to download. Any updates will be announced and posted on our website’s bulletin board and BackOffice. With the release of this new guide we hope you will find it useful and informative. We expect everyone to revise their websites and any marketing materials in accordance with what is outlined in the guide.
The FDA has made it clear to MLM companies that they hold both the distributor and the company responsible for the information on a distributor’s website. So it is both of our responsibility to police ourselves to prevent the FDA from contacting us. We have never been reprimanded from the FDA regarding health claims and would like to keep it that way so please help us in this effort to protect both you and us. After all, we do not need to make claims about our products, we should let the products speak for themselves. Once people try it, they will experience the power of it.
Mahalo, Richway & Fuji Bio Inc.
Marketing Guidelines for Independent Sales Associates
Our company makes really wonderful products which have helped thousands of people in a variety of ways. Just like you, we have witnessed the results and have always been eager to share them. We want to be truthful and honest about our company and our products. We do not want to mislead anyone into believing our products can do anything beyond their FDA and/or FTC approval. So we have created this manual to inform our Independent Sales Associates of the laws that apply to marketing our products. The guidelines here apply to anyone selling Richway & Fuji Bio products and applies to all platforms (e.g. verbal, printed, video, social media, etc.).
Here are some tips for sharing our products the right way to protect yourselves and the company.
FDA and FTC
There are two Government agencies which regulate the products that we sell.
The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health. For our purposes, they regulate the claims about our products. The FDA isn’t only interested in how truthful the claims are, their concern is to make sure the claims are legal and permitted.
The Federal Trade Commission (FTC) is an agency which promotes consumer protection and anticompetitive practices. For our purposes, they regulate the advertising of our products. Both agencies often work closely together and use similar evidentiary standards when determining legality. So we must be vigilant in following the laws.
The Food and Drug Administration
Section 201(h) of the Food, Drug and Cosmetic Act (the Act). 21 U.S.C. § 321(h), applies to the Biomat as the products are devices that intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, o r are intended to affect the structure or function of the body. Further, the Code of Federal Regulations -specifically 21 CFR Part 801.6-defines misleading statements as misbranding the product, which can lead to federal action against the manufacturer or distributor and can included seizure, injunction, and/or civil money penalties. For more information see: Food, Drug and Cosmetic Act http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/ Dietary Health and Education Act http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct /SignificantAmendmentstotheFDCAct/ucm148003.htm
How does the FDA define a disease?
Dietary Health and Education Act,Section 101.93(g) defines disease as: damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutri ent deficiencies (e.g., scurvy, pellagra) are not included in this definition. Although the majority of our products are devices and not food products, it is important to understand this law because there is a fine line between what is and is not a disease claim. The FDA needs to approve disease claims and they can only made for products approved as drugs or for foods that are qualified to make “health claims.”
TIPS1. Do not make any claims which diagnose, treat, cure, mitigate or preventa disease. 2. Disease claims are only allowed for drugs and approved foods. 3. Do not imply a disease claim. 4. Context is everything.
The following list will help you avoid making disease claims.
1. Do not make a statement that a product has an effect on a disease or class of diseases. Avoid naming diseases that the Biomat has not been approved to treat. A statement becomes a disease claim by mentioning a disease or class of diseases. For example, a claim that a product is "protective against the development of cancer" or "reduces the nerve pain associated with diabetes" would be a disease claim. A statement also is a disease claim if it implies that it has an effect on a specific disease or class of diseases by using descriptions of the disease state. Examples of implied disease claims are "relieves crushing chest pain (angina)," or "relief of bronchospasm (asthma)." (for more information see the Dietary Health and Education Act, section E, starting on page 1012 of the preamble to the rule)
2. Do not make a statement that refers to a characteristic sign or symptom of disease. What are signs and symptoms of a disease? Signs of disease are apparent or measurable by a doctor such as a high blood pressure reading, high macrophage count, or poor reflex response. Therefore the advertiser needs to have proof to back up an implied and expressed claim. The law requires that advertisers have proof of their claims before any advertisement runs. When you advertise a product the FTC says you must have “reasonable basis” for the claims you make, which means “objective evidence that supports the claim.” The FTC looks at what experts in the field of the product think is needed to support the claims made. Health and safety claims must be supported by competent and reliable scientific evidence evaluated by people who are qualified to review it. They also state “any tests or studies must be conducted using methods that experts in the field accept as accurate.” The FTC goes further and says customer testimonials are not enough to back up a claim “statements from satisfied customers usually are not enough to support a health or safety claim or any other claim which requires objective evaluation.” (For more information see the Federal Trade Commission Act, and the FTC policy on deception) Every state has consumer protection laws. Learn the local consumer laws in your area.
3. Endorsement and Testimonials The FTC views testimonials by customers and endorsements by celebrities and experts the same. All endorsements must reflect the honest experience or opinion of the endorser. They cannot be deceptive, and must be substantiated as if the advertiser made them directly. The following are guidelines provided by the FTC. Endorsements and testimonials must reflect the typical experience of consumers who use the product, not just the experience of a few. Otherwise they must disclose what a customer can expect. According to the FTC saying “your results may vary” is not enough. A celebrity or expert endorsement must honestly reflect the experience and opinion of the person. If the ad represents the person using it, the person must actually use it. For as long as you plan on using this endorsement the FTC says the advertiser “has an obligation to make sure the endorsement continues to reflect the endorser’s opinion.” On expert endorsements, the person must be qualified and considered to be an expert in the field. The expert endorsement must also be substantiated by an actual “evaluation, examination or testing of the product that other experts in the field normally would conduct to support the conclusions in the endorsement.” If the person endorsing the product is paid, is a relative of the company, or is an employee this fact must be disclosed to the consumer. (for more information see section 5 FTC Act (15 U.S.C. 45))
4. Advertising on the internet All forms of advertising verbal, printed, video, radio, and internet are covered under the FTC law. The above rules apply to websites, flyers, brochures, Youtube, Twitter, Facebook, and other social media sites. (for more information see FTC guide Advertising and Marketing on the Interne t, and the other information on their website)
Do’s and Don’ts
When promoting our products we must follow the FDA and FTC rules. Do not forget context is everything. So if you are writing your own content you must be very careful and follow the rules.
The Biomat is approved by the FDA for the following claims. The 510k indications for use states “Temporary relief of minor muscle pain, minor joint pain and stiffness, join paint associated with arthritis, muscle spasms, minor sprains, minor strains, minor muscular back pain, relaxation of muscles, and temporary increase of local circulation where applied.”
Richway & Fuji Bio approved claims for the Biomat products
- Relieves minor muscle pain in areas where applied
- Increases blood circulation in areas where applied
- Reduces stress and fatigue
- Soothes and relaxes
- Eases minor joint pain,and stiffness
- Supports the immune system
- Improved sleep (if associated with pain relief)
- Reduced inflammation (where applied)
- Increased tissue oxygen (due to increased circulation where applied)
- Minor muscular back pain
- Temporary relief of sprains and strains
- Temporary relief of minor muscle and joint pain and stiffness
- Temporary relief of joint pain associated with arthritis
- Temporary relief of muscle spasms
- Temporary increase of local circulation where applied
- Relaxation of muscles
- Promotes relaxation by application of heat
- Promotes restful sleep for those with occasional sleeplessness
Below is a partial list of terms and ailments that must be avoided when promoting any Biomat product.
Detoxification of the blood, Hormone Balance, Lymphatic drainage, Persistent or recurring infection (Frequent colds, parasites, Lyme, etc...), Anxiety Relief, Regeneration of damaged cells, HIV, Hepatitis, Diabetes, Cancer, lymphoma, neoplasm, tumor, Immune system resilience, Fibromyalgia , Cardiovascular health, Elevates mood, Improves absorption of nutrients, Strengthens the functions of autonomic nerves, Relieves allergies, migraines and sinus problems, Reduces or Eliminates asthma symptoms, Purifies the air and surroundings, Alkalize the body, Purify the blood, Support all detoxification pathways of the body, Relieve chronic constipation, Kills Cancer Cells, Decrease of hyperactivity, Psychological well-being, Destroys viruses, Balances pH by decreasing acidity, Balances blood sugar, Gastroenteritis, Improves liver function , Counteracts poisons, Reduces symptoms of paralysis, Strengthens Colon, Kidneys, Burns Calories, Increases Serotonin Levels, Subdues Sinus Problems, Improves Memory Skills, Regulates Intestinal Flora, Decreases Blood Pressure, Improves chronic Lyme-related issues, Detoxification from mold-related mycotoxins, ALS (Amyotrophic lateral sclerosis-Lou Gehrig’s disease)
Negative Ion and Far Infrared Therapy Benefits
As we know many of the benefits for the Biomat comes from negative ions and far infrared rays. However, there is a problem when we discuss these benefits in conjunction with the Biomat. For those of you who write your own materials, keep all information about negative ions and far infrared rays separate from the Biomat. It is best to have your own negative ion and far infrared research pages. Do not mention the Biomat on these pages. Information should be presented with the science to back it up along with the study’s entire abstract and link to the study.
The use of customer testimonials is very dangerous. If you do plan on using testimonials, you need to make sure the testimonials follow the FDA and FTC guidelines. The customers experience is not enough. Edit your testimonials so they are legal. [We chose not to violate copyright law for those testimonials from Bio-Mat users and blanked out the offending words on the Testimonials Page]
After a good amount of time on the large Biomat and pad, I am beginning to really reap the benefits and am a lot more comfortable than in years. The Fibromyalgia with all of its side effects has definitely diminished... Jane Doe
After a good amount of time on the large Biomat and pad, I am beginning to really reap the benefits and am a lot more comfortable than in years .. . Jane Doe
Don’t Forget Context is Everything
1. In the example below, this web page has an article on cancer prevention and has a Biomat ad on it. The FDA and FTC could say that this is implying a disease claim. Do not mix the Biomat with information that is not on the FDA approved 510k indications for use.
2. Choose the pictures for your articles wisely. It is easy to imply a disease claim depending on the context of the text accompanying the picture.
ConclusionRichway & Fuji Bio has never been in trouble with the FDA or FTC regarding disease claims and we want to keep it that way by sharing these tips with you. We hope that you will learn a lot from this guide and apply the new knowledge to your website and sales aides. Please share this with your team members and your down-line so we can work together to regulate ourselves.
DisclaimerThis manual is a living document and will be edited and updated as new information arises. This manualis for educational purposes only and should be viewed as a guideline. This manual is not intended to replace legal advice. The examples provided in this document do not represent a complete or exhaustive list of all acceptable and unacceptable claims. You should consult with your own legal counsel when determining how to apply the information presented in this document to your own materials.
Further terms no longer allowed in reference to the Bio-Mat
The following conditions were not part of the Marketing Guidelines above, which provides examples only of offending conditions that the FDA/FTC deems that cannot be even implied as helping such ailments:
- Cancer, Leukemia, Prostate Cancer
- Asthma, Bronchitis, Sinus problems.
- Excess Body Fat/Weight Loss, Cellulite, Obesity.
- High Blood Pressure, Chronic Nephritis.
- Circulation problems - Body Odor.
- Rheumatism, Chilblains, Gout.
- Hemorrhoids and Piles.
- Swelling, Inflammation - Arthritis
- Tendinitis, Tumors, Mastitis
- Back, Shoulder, Neck and Muscular Pains.
- Neuralgia and Abnormal Nerve Functions.
- Herpes, Paralysis, Sciatica Skin Elasticity and Texture.
- Chapping, Skin Aging, Wrinkles.
- Damaged, Burnt and Scarred Tissue
- Clogged Pores, Pimples, Acne
- Toxicity, Hepatitis, Cirrhosis, Cystitis, Uric Acid.
- Gastric and Duodenal Ulcers.
- Menstrual problems, PMS, Yeast problems
- Fungus, Viruses, Bacteria, Parasites.
- Migraine, Headaches, Nose Bleeds - Earache,
- Tinnitus. (Ringing in the Ears)
- Carpal Tunnel Syndrome
- Diabetes Mellitus.
- Sports Injuries - Colds, Flu, Fever.
- Ear Diseases.
- Gastroenteric Problems.
- Shoulder Stiffness.
- Arthritis, Gout, Rheumatoid, DJD (each substantially relieved or improved).
- Adhesions (common in competitive athletes, trauma, and repetitive stress syndromes).
- TMJ Arthritis.
- Acel-Decel Injury Sequelae.
- Low-Back Pain (relieved).
- Bursitis (eliminated).
- Brain Contusion (accelerated healing).
- Disc-Protrusion Related Neuralgia.
- Compression Fractures (in one situation pain stopped for three days with one treatment).
- Muscle Tension (relaxed).
- Muscle Spasms (reduced or eliminated).
- Post-Exercise Muscle Pain (good results - vital to competitive athletes).
- Shoulder pain (relieved or improved).
- Spinal Chord Shock (reversed post traumatic shock).
- Tight Shoulders (more relaxed).
- Traumatic Arthritis.
- Body Odor.
- Chronic middle-ear inflammation of infection.
- Clogged pores (unplugged of cosmetics, unexcelled skin texture and tone).
- Dandruff (increased blood flow through the scalp).
- Eczema and Psoriasis (respond well).
- Lacerations (healed quicker with less pain and scarring).
- Nettle rash.
- Nose bleeding (reduced).
- Skin Conditions (improved).
- Teenage skin problems (clearing acne and blackheads).
- Poor skin tone - Scars and pain from burns or wounds (decreased in severity and extent).
- Sore throats.
- Tinitus (chronic severe case cleared with 10 infrared treatments).
- Used routinely in burn units throughout Asia.
- Shoulder Stiffness
- Gastroenteric Problems
- Ear Diseases
- Burns (relieves pain and decreases healing time with less scarring)
- High blood pressure (safe in 40 to 50 degrees Celsius, 104 to 122 degrees Fahrenheit, regular use helps lower pressure)
- Low blood pressure (sauna trains the body to raise the pressure)
- Brain damage (accelerated repair in brain contusions)
- Short-term memory loss (improved)
- Cancer of the tongue (improved)
- Toxic electromagnetic fields (effects neutralized)
- Cerebral hemorrhage (speeds and significantly enhances recovery)
- Arthritis, acute and chronic (greatly relieved)
- Gouty arthritis (relieved)
- Rheumatoid Arthritis (relieved)
- Menopausal symptoms (relieved chills, nervousness, depression, dizziness, head- and stomach-aches)
- Weight loss (produced through sweating, the energy expended to produce sweating, and through direct excretion of fat)
- Auto accident-related soft tissue injury