General FAQ

What is a medical food?

A medical food is a classification of the FDA which is not a supplement or a pharmaceutical drug. Medical foods are products specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.

Why do your products require a prescription or attestation that the patient is under medical supervision?

As medical foods, our products must be taken under the supervision of a physician or health care provider.  Thus, our products are labeled with the statement:  Use only under medical supervision.  To ensure this FDA requirement is met, VAYA  makes its products available via a prescription or patient attestation stating that the patient is under the medical supervision of a health care provider.   If you are purchasing our products out-of-pocket through VAYA Direct, you are only required to affirm through a patient attestation statement that you or the patient is under the supervision of a health care provider. If ordering through VAYA Direct and utilizing insurance coverage or paying using funds from a Health Savings Account (HSA)**, submission of a health care provider prescription is required.   If you are planning to purchase our products through a retail pharmacy, a prescription will be required to obtain the product.

How can I get my doctor to prescribe/recommend VAYA products?

We are happy to provide you and your health care provider with additional information through mail and email, along with the support of our product information manager. If you wish to provide us with your health care provider’s information, we can have a field sales representative and/or product information manager reach out to them as soon as possible.

Do I need a prescription to purchase VAYA's products online?

If you choose to purchase our products through VAYA Direct’s online ordering system and pay out-of-pocket without any reimbursement, you will not be required to provide a health care provider prescription.   Since our products are medical foods that must be taken under the supervision of a physician or health care provider, you will be required to affirm through a patient attestation statement  that you or the patient is under the medical supervision of a health care provider.

Are there any coupons/deals that you can offer to help cost?

VAYA Direct offers $20 off the first 180-count bottle of Vayarin® or Vayarin® Plus, or the first 90-count bottle of Vayacog® ordered through VAYA Direct. Introductory coupons are limited to one per customer. Please be sure to check www.vayadirect.com, our Facebook product pages, and our email newsletter for additional promotional offers.

Are VAYA's products FDA approved?

VAYA’s products are regulated as medical foods, and not as pharmaceutical drugs or over-the-counter products. Products within the medical food category are tightly regulated by the FDA. In order to be considered by the FDA as a medical food, each product must meet several requirements. Most of these requirements relate to the quality and safety of the products.

Does insurance cover VAYA Pharma’s products (Vayarin®, Vayacog®, Vayarin® Plus)?

As medical foods, VAYA Pharma products are not universally covered by insurance. VAYA Pharma is always striving to expand insurance coverage and recommends that patients to contact their insurance provider to determine if they are covered. There are instances where insurance providers will provide coverage for our products. A prescription is generally required by insurance companies in order to process coverage.

Where can I find VAYA Pharma’s products?

VAYA currently sells its products in the U.S., Singapore, Hong Kong, Turkey and Israel. VAYA is expanding quickly and is actively working to grow in other countries across the world.

Is the harvesting of fish/krill to source the material for your products sustainable?

VAYA Pharma supports sustainable management of krill and fish populations and an eco-friendly supply chain to maintain the conservation of marine life sources.

Vayarin® FAQ

What is the difference between Vayarin® and fish oil omega-3?

Vayarin® is a unique composition containing Phosphatidylserine attached to Omega-3 fatty acids (PS-Omega-3) EPA enriched. Fish oil has a different composition from Vayarin®. Fish oil usually contains omega-3 in a different kind of lipid structure called a triglyceride. Vayarin® has a unique composition containing Phosphatidylserine attached to Omega-3 fatty acids (PS-Omega-3) EPA enriched and has no generic version in the market. This specially formulated composition is designed so more of the lipid nutrients effectively reach and are absorbed by the brain cells. Vayarin® was clinically tested and shown to reduce several ADHD behaviors.

When should the patient take the capsules?

Morning or evening: it’s recommended to take Vayarin® at the same time every day to help you remember to take it. Some patients take 1one capsule in the morning and one capsule in the evening, and some take both at once. It is recommended to take Vayarin® with a meal.

What are Vayarin®’s ingredients?

Vayarin® is a unique, patent-protected composition containing generally recognized as safe (GRAS) ingredients. Vayarin® contains phosphatidylserine bonded to omega-3 EPA enriched and is derived from krill harvested from the cold waters of the Antarctic Ocean.

Is Vayarin® natural?

Vayarin® is derived from a natural source.

Why does it take 30-90 days for Vayarin® to start working in the body?

Vayarin® takes time to accumulate in the system. It takes an average of 30-90 days for Vayarin® to build up in the body in order to see an optimal effect on ADHD behaviors.

I am (my child is) allergic to soy/fish/shellfish – can I (he/she) still take Vayarin®?

Vayarin® is derived from krill – a shellfish. Vayarin® is not recommended for patients with shellfish allergies. Vayarin® may contain soy or fish as it is produced in a facility that also has soy and fish based products.

Does Vayarin® contain sugar, lactose, yeast or gluten?

No.

Is there any Medicaid or Medicare coverage for Vayarin®?

Vayarin® is not covered by Medicare or Medicaid, but VAYA tries to keep the out-of-pocket price of its products affordable in order to help alleviate costs. VAYA Direct is the lowest-price channel for obtaining Vayarin®. VAYA Direct offers $20 off the first 180-count supply bottle ordered by new customers.

Are there any side effects from Vayarin®?

The most common side effect reported in the clinical studies is gastrointestinal (GI) discomfort such as upset stomach, gas, bloating or fishy burps for both products. This side effect can be minimized by taking with food and storing in fridge. For more information, we can email you our product information.

Is it safe to take Vayarin® if I am pregnant or breastfeeding?

Vayarin® was not clinically tested in pregnant or lactating women. Thus, it is not recommended for these patients. We suggest you consult with your HCP if you have further questions about this issue.

What if my child missed a dose of Vayarin®?

If a dose has been skipped or missed, simply take it when you remember and continue as usual.

Are there other ways to take Vayarin® if a patient can’t / refuses to swallow pills?

Vayarin® capsules can be opened and sprinkled on food. The foods and beverages that work best are peanut butter, applesauce, yogurt, jelly and hazelnut spread. Due to our product’s heat sensitivity, be sure to mix it into a room-temperature food, and you’ll want to encourage your child to eat the entire dish.

What are the age and/or weight guidelines for determining whether Vayarin® or Vayarin® Plus is the recommended product?

Both products are indicated based on age: Vayarin® is intended for children between 6 and 13 years of age, regardless of weight. Vayarin® Plus is intended for adolescents aged 14 and above and adults. If the patient is 14 or above, the recommended weight threshold for Vayarin® Plus is greater than or equal to 97 lbs.

Should I/my child switch from Vayarin® to Vayarin® Plus?

We suggest that you consult with your HCP about what is best for your/your child’s individual diagnosis and needs. Based on clinical trial data, Vayarin® is intended for children 6-13 years while Vayarin® Plus is intended for 14+ (and 97 lbs. or greater) and adults.

How long can Vayarin® be exposed to/stored in high temperatures without affecting the stability or efficacy of the products?

Vayarin® should be stored at 77 degrees Fahrenheit and not stored at high temperatures. VAYA has conducted quality control experiments to test the stability of Vayarin® exposed to high storage temperatures for temporary periods of time. We have certifications which ensure through testing that the ingredients of our products are stable for up to 96 hours/4 days at a temperature of up to 104 degrees Fahrenheit and up to 48 hours/2 days at a temperature of up to 140 degrees Fahrenheit.

Vayacog® FAQ

What is the difference between Vayacog® and fish oil omega-3?

Vayacog® is a unique composition containing Phosphatidylserine attached to Omega-3 fatty acids (PS-Omega-3) DHA enriched. Fish oil has a different composition from Vayacog®. Fish oil usually contains omega-3 in a different kind of lipid structure called a triglyceride. Vayacog® has a unique composition containing Phosphatidylserine attached to Omega-3 fatty acids (PS-Omega-3) DHA enriched and has no generic version in the market. This specially formulated composition is designed so more of the lipid nutrients effectively reach and are absorbed by the brain cells. Vayacog® was clinically tested and shown to improve short-term and long-term memory as well as learning abilities.

What are Vayacog®’s ingredients?

Vayacog® is a unique patent protected composition containing generally recognized as safe (GRAS) ingredients. Vayacog® contain phosphatidylserine bonded to omega-3 DHA enriched derived from oily fish.

A small amount of soy is added to the finished product.

Is Vayacog® natural?

Vayacog® is derived from a natural source.

Why does it take 30-90 days for Vayacog® to start working in the body?

Because Vayacog® takes time to accumulate in the system, it takes an average of 30-90 days for Vayacog® to build up in the body in order to see the optimal effect on Early Memory Impairment (EMI) symptoms.

If the patient is allergic to soy and fish can he or she still take Vayacog®?

Vayacog® is derived from fish with a small amount of soy added to the finished product. Vayacog® is not recommended for patients with fish or soy allergies. Vayacog® may contain krill as it is produced in a facility that also has krill based products

Does Vayacog® contain sugar, lactose, yeast, or gluten?

No.

When should the patient take Vayacog®?

Morning or evening: it’s recommended to take Vayacog® at the same time every day to help you remember to take it, and it is also recommended to take it with a meal.

Is there any Medicaid or Medicare coverage for Vayacog®?

Vayacog® is not covered by Medicare or Medicaid, but VAYA Pharma tries to keep the out-of-pocket price of their products affordable in order to help alleviate costs. VAYA Direct is the lowest-price channel for obtaining Vayacog®. VAYA Direct offers $20 off the first 90-count supply bottle ordered by new customers.

Are there any side effects from Vayacog®?

The most common side effect reported in the clinical studies is gastrointestinal (GI) discomfort such as upset stomach, gas, bloating or fishy burps. This side effect can be minimized by taking with food and storing in the fridge. For more information, we can email you product information for Vayacog®.

Is it safe to take Vayacog® if I am pregnant or breastfeeding?

Vayacog® was not clinically tested in pregnant or lactating women. Thus, it is not recommended for these patients. We suggest you consult with your HCP if you have further questions about this issue.

What if the patient missed a dose of Vayacog®?

If a dose has been skipped or missed, simply take it when you remember and continue as usual.

Are there other ways to take Vayacog® if a patient can’t or refuses to swallow pills?

Vayacog® capsules can be opened and sprinkled on food. The foods and beverages that work best are peanut butter, applesauce, yogurt, jelly and hazelnut spread. Due to our product’s heat sensitivity, be sure to mix it into a room-temperature food, and you’ll want to encourage the patient to eat the entire dish.

How long can Vayacog® be exposed to/stored in high temperatures without affecting the stability or efficacy of the products?

Vayacog® should be stored at 77 degrees Fahrenheit and not stored at high temperatures. VAYA has conducted quality control experiments to test the stability of Vayacog® exposed to high storage temperatures for temporary periods of time. We have certifications which ensure through testing that the products’ ingredients are stable for up to 96 hours/4 days at a temperature of up to 104 degrees Fahrenheit and up to 48 hours/2 days at a temperature of up to 140 degrees Fahrenheit.

Vayarin® Plus FAQ

What is the difference between Vayarin® Plus and fish oil omega-3?

Vayarin® Plus is a unique composition containing Phosphatidylserine attached to Omega-3 fatty acids (PS-Omega-3) EPA enriched. Fish oil has a different composition from Vayarin® Plus. Fish oil usually contains omega-3 in a different kind of lipid structure called a triglyceride. Vayarin® Plus has a unique composition containing Phosphatidylserine attached to Omega-3 fatty acids (PS-Omega-3) EPA enriched and has no generic version in the market. This specially formulated composition is designed so more of the lipid nutrients effectively reach and are absorbed by the brain cells. Vayarin® Plus was clinically tested and shown to reduce several ADHD behaviors.

When should the patient take the capsules?

Morning or evening: it’s recommended to take Vayarin® Plus at the same time every day to help you remember to take it. Some patients take 1 in the morning and 1 in the evening, and some take both at once. It is recommended to take Vayarin Plus with a meal.

What are Vayarin® Plus's ingredients?

Vayarin® Plus is a unique, patent-protected composition containing generally recognized as safe (GRAS) ingredients. Vayarin® Plus is derived from krill harvested from the cold waters of the Antarctic Ocean.  For additional information we can email you our product information.

Is Vayarin® Plus natural?

Vayarin® Plus is derived from a natural source

Does Vayarin® Plus contain genetically-modified ingredients?

No, Vayarin® Plus does not contain genetically modified ingredients. It is certified non-GMO.

Can Vayarin® Plus be taken with medications or OTC products?

VAYA’s products are not medications but medical foods and are intended for use under medical supervision. No drug-to-drug interactions were reported for the use of Vayarin® Plus with medications or OTC products. If you have concerns about the product please contact your health care provider.

Why does it take a long time for Vayarin® Plus to start working in the body?

Vayarin® Plus takes time to accumulate in the system because it is compensating for and managing nutritional imbalances. It is not a “quick fix”. It takes an average of 4 to 8 weeks for Vayarin Plus to build up in the body in order to see an optimal effect on ADHD behaviors.

Can a patient take Vayarin® Plus with his/her current ADHD medications?

Vayarin® Plus efficacy was tested in ADHD patients not taking any ADHD medications. Vayarin Plus ingredients are safe and well tolerated. Your health care provider should decide the best approach to help address the patient’s behavior.

I am allergic to shellfish. Can I still take Vayarin® Plus?

Vayarin® Plus is derived from krill – a shellfish. Vayarin® Plus is not recommended for patients with shellfish allergies.

Does Vayarin® Plus contain sugar, lactose/dairy, yeast or gluten?

No.

Are there any side effects from taking Vayarin® Plus?

The most common side effect reported in the clinical studies is gastrointestinal (GI) discomfort such as upset stomach, gas, bloating or fishy burps. This side effect can be minimized by taking with food and storing in fridge. For more information, we can email you our product information.

What if I miss a dose of Vayarin® Plus?

If a dose has been skipped or missed, simply take when you remember and continue as usual.

Are there other ways to take Vayarin® Plus if a patient can't or refuses to take the capsules?

Vayarin® Plus capsules can be opened and sprinkled on food. The foods and beverages that work best are peanut butter, applesauce, yogurt, jelly and hazelnut spread. Due to our product’s heat sensitivity, be sure to mix it into a room-temperature food.

Where should I store Vayarin® Plus?

VAYA has conducted quality control experiments to test the stability of Vayarin® exposed to high storage temperatures for temporary periods of time. We have certifications which ensure through testing that the products’ ingredients are stable for up to 96 hours/4 days at a temperature of up to 104 degrees Fahrenheit and up to 48 hours/2 days at a temperature of up to 140 degrees Fahrenheit. Vayarin Plus® should not be stored over temperatures of 140 degrees Fahrenheit.

We recommend storing at up to 77°F (25°C) and protecting from light and moisture.

What is the difference between Vayarin® and Vayarin® Plus?

Vayarin® is intended for children between the ages of 6-13 years. Vayarin® Plus is an extra-strength version of Vayarin® which is intended for adolescents/adults (above 14) above 97lbs. Vayarin® Plus is 3 x the dose of Vayarin®. Vayarin® capsule has 75mg of Lipirinen™, and a daily dose of 150mg of Lipirinen™. Vayarin® Plus capsule has 225mg of Lipirinen™ and a daily dose of 450mg of Lipirinen™. Vayarin® Plus capsules are bigger.

Is it safe to take Vayarin® Plus if I am pregnant or breastfeeding?

Vayarin® Plus was not clinically tested in pregnant or lacatating women. Thus, it is not recommended for these patients. We suggest you consult with your HCP if you have further questions about this issue.

Is there a weight threshold requirement for adolescents and adults to meet before taking Vayarin® Plus?

Vayarin® Plus is intended for adolescents/adults (above 14) above 97 lbs or as directed by a health care provider.

Can a child take Vayarin® Plus?

Vayarin® Plus was not clinically tested in children. Vayarin® Plus is intended for adolescents 14+ and adults.

What are the age and/or weight guidelines for determining whether Vayarin® or Vayarin® Plus is the recommended product?

Both products are indicated based on age: Vayarin® is intended for children between 6 and 13 years of age, regardless of weight. Vayarin® Plus is intended for adolescents aged 14 and above and adults. If the patient is 14 or above, the recommended weight threshold for Vayarin® Plus is greater than or equal to 97 lbs.

Should I/my child switch from Vayarin® to Vayarin® Plus?

We suggest that you consult with your HCP about what is best for your/your child’s individual diagnosis and needs. Based on clinical trial data, Vayarin® is intended for children 6-13 years while Vayarin® Plus is intended for 14+ (and 97 lbs. or greater) and adults.