WARNING LETTER
Speedwinds Nutrition, Inc.
MARCS-CMS 609298 —
December 22, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Clayton J. Montgomery
Recipient Title
President
Speedwinds Nutrition, Inc.
818 SW 3rd Avenue
Portland
,
OR
97204
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
December 22, 2020
In reply, refer to CMS 609298
WARNING LETTER
Dear Mr. Montgomery:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.speedwinds.com in December 2020, and has determined that you take orders there for the products Synotrex and Sephren. We also reviewed your website at www.speedwindsnutrition.com, which contains links to www.synotrex.com and www.sephren.com where the products can be purchased. Furthermore, we reviewed www.amazon.com where you sell Synotrex. The claims on your websites and Amazon storefront establish that the Synotrex and Sephren products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include the following:
Synotrex
On the Synotrex webpage on www.speedwinds.com website:
• “[W]e have developed the most effective joint pain product on the market!”
• “Within a few short days of using Synotrex, you can expect the following benefits: Reduced joint pain, swelling and stiffness . . . Rebuild worn out and damaged cartilage . . . Relief of chronic pain . . . Minimize discomfort from osteoarthritis or injury.”
On the product website at www.synotrex.com:
• “Proven to Reduce Pain & Swelling in 30 Days or Less!”
• “Safely & Naturally Eliminate Joint Pain Without a Prescription”
• “Whether you suffer from inflamed cartilage in your joints - commonly known as arthritis . . . Synotrex can help you regain mobility, safely and naturally without the use of dangerous prescription drugs.”
• “Within 2 weeks of using Synotrex, you can expect the following benefits: Reduced joint pain, swelling and stiffness . . . Rebuild worn out and damaged cartilage . . . Relief of chronic pain . . . Minimize discomfort from osteoarthritis or injury.”
• “Each dose of Synotrex delivers powerful phytonutrients to your body to fight the causes of joint degeneration and reduce associated pain.”
• “Synotrex is a scientifically designed supplement to repair injured or damaged joint tissue . . . Whether you suffer from arthritis . . . Synotrex can provide you with a safe and effective program for healthy joints.”
• “Synotrex has been shown to alleviate joint pain related to . . . osteoarthritis . . . This is accomplished by offsetting joint space narrowing and the loss of cartilage within the joint . . . rebuild cartilage damaged by injury, repetitive motion, and osteoarthritis . . .”
• “Synotrex contains a proven blend of glucosamine and chondroitin that is the most effective in treating osteoarthritis.”
On the webpage titled “Rheumatic Diseases and Arthritis :: Synotrex” at www.synotrex.com/rheumatoid-arthritis.html which contains links to purchase your Synotrex product:
• “Rheumatic diseases are characterized by inflammation . . . There are more than 100 rheumatic diseases . . . Examples of Rheumatic Diseases . . . Osteoarthritis . . . Rheumatoid arthritis . . . Juvenile rheumatoid arthritis . . . Fibromyalgia . . . Gout . . . Infectious arthritis . . . Psoriatic arthritis … Bursitis . . . Tendinitis.”
• “Experience the Amazing Joint Pain Relief You Can Achieve with Synotrex!”
On the webpage titled “Chronic Joint Pain :: Synotrex” at www.synotrex.com/chronic-joint-pain.html, which contains links to purchase your Synotrex product:
• “Chronic Joint Pain is a severe problem that strikes more than 100 million Americans each year . . . Arthritis can be treated either medically or more naturally. Medical options include: Corticosteroids . . . DMARDs or SAARDs . . . NSAIDs . . . More natural treatment options on the market include a number of supplements and herbs that work similar ways to the above drugs, but with less side effects.”
• “Experience the Amazing Joint Pain Relief You Can Achieve with Synotrex!”
On the webpage titled, “Turmeric :: Synotrex Ingredients” at www.synotrex.com/join-pian-turmeric.html:
• “For thousands of years, turmeric [an ingredient in your Synotrex product] has also been sued [sic] as an anti-inflammatory supplement. It is known to be a pain relieving agent as well, and a 2006 issue of ‘Arthritis and Rheumatism’ recognized the effects of turmeric for reducing joint inflammation, treating arthritis symptoms and inhibiting an enzyme known as cox-2, which has been shown to lessen neuropathic pain, Turmeric has also been shown to reduce melanoma (cancer) cells as well as prevent psoriasis and cystic fibrosis. It may even slow the spread of breast cancer.”
• “A UCLA research center found that turmeric may be useful in preventing some of the destruction to Alzheimer's patients, as the active ingredient in Turmeric (curcumin) has been shown to inhibit the production of beta almyloids.”
• “[I]t's [sic] anti-inflammatory properties as well as its ability to reduce pain make it a useful herbal supplement for preventing joint pain cause by osteoarthritis.”
On the webpage titled, "SAM-e (S-adenosylmethionine) :: Synotrex Ingredients” at www.synotrex.com/join-pian-sam-e.html:
• “SAM-e (S-adenosylmethionine) [an ingredient in your Synotrex product] … is used in Europe as an all natural anti-depressant as well as a pain killer for joint pain. It has been researched thoroughly for its many natural abilities by natural biopsychologists searching for alternative medicines for depression, fibromyalgia, chronic fatigue and arthritis.”
• "SAM-e may reduce toxicity in the liver during cancer treatments. It has also been shown to . . . fight insomnia . . .”
• “It has some anti-inflammatory properties and has also been known to heal tissues in order to protect joints and reduce joint pain. It has shown itself to be as effective as many NSAIDs (Non-steroidal anti-inflammatory drugs) . . . ”
• “SAM-e . . . has been shown to help reduce depression, since a low dose of SAM-e can cause depression and sleep issues.”
On the Synotrex webpage on your Amazon.com storefront:
• “FIGHTS INFLAMMATION: Eases joint inflammation safely & naturally for better movement . . . Synotrex's formula is all natural, side effect free and fights joint pain.”
• On your graphic titled, “ALL-NATURAL SUPPLEMENT FOR JOINT PAIN”:
o “RELIEVES CHRONIC PAIN”
• On your graphic titled, “ADVANTAGES”:
o “Synotrex . . . fight the causes of joint degeneration and reduce associated pain.”
o “[The] ingredients in Synotrex alleviate the constant pain and inflammation that you feel in your joints . . .”
Sephren
On the webpage titled, “HAIR LOSS IN WOMEN” at www.sephren.com/hair-loss-in-women, which contains links to purchase your Sephren product:
• “[M]ajor surgery can also cause changes in the body that can lead to hair loss . . . Problems with the thyroid gland or immune system of the body can also cause hair loss. Some medications such as non-steroidal pain relievers, chemotherapy drugs and antidepressants can also cause hair loss.”
• “With Sephren, you can feel confident that Sephren will: . . . Stop the root causes of hair [sic] female hair loss.”
On the webpage titled, “CAUSES OF FEMALE HAIR LOSS” at www.sephren.com/female-hair-loss, which contains links to purchase your Sephren product:
• “Telogen Effluvium . . . occurs after some kind of stressful event on the body . . . Hormonal imbalances such as hypothyroidism can often cause hair loss in women . . . Certain vitamin and mineral deficiencies also lead to hair loss. Acute and infectious illness can put a strain on the body and send hair into a resting phase causing hair loss.”
• “Alopecia Areata . . . is often thought to be an autoimmune response from the body… Thyroid disease can also trigger this type of hair loss in women.”
• “With Sephren, you can feel confident that Sephren will: . . . Stop the root causes of hair [sic] female hair loss.”
Your website www.synotrex.com also contains evidence of intended use in the form of quotes attributed to media organizations and personal testimonials recommending or describing the use of Synotrex for the cure, mitigation, treatment, or prevention of disease. Examples of such media and personal testimonials include:
• “Clearly, research has demonstrated that chondroitin [an ingredient in your Synotrex product], especially when taken with glucosamine [an ingredient in your Synotrex product], has shown a benefit for those suffering from osteoarthritis. To discourage its use as a treatment option is ill-considered, particularly when the alternatives are limited or nonexistent.”
• “After suffering a knee injury in college 20 years ago, I have been dealing with bad knee pain. I've tried all kinds of stuff, but no matter what, nothing really makes it feel better. My wife saw an ad for Synotrex, so she bought me some. I took it reluctantly, but amazingly enough it really worked. Synotrex has made a huge difference and am now able to be active again.”
• “Before finding Synotrex, I was really starting to miss out on a lot life's special moments. I've had arthritis for years and have always struggled with it. I found Synotrex online and it seemed to address my needs. after [sic] using it consistently for 4 months, I'm a new person. My RA has gotten a lot better and more importantly, I can keep up with my grandchildren. I no longer feel like I'm missing out!”
• “[A] friend recommended Synotrex, and I’ve rediscovered what it’s like to live without joint pain.”
Your Synotrex and Sephren products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. 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 and information demonstrating that the drug is safe and effective.
Furthermore, your Synotrex product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that 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 your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address 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 addressing these violations within fifteen (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: Jinkee M. Vila-Binayug, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions regarding this letter, please contact Compliance Officer Vila-Binayug at
425-302-0413
.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
01/12/2021
Regulated Product(s)
Dietary Supplements