Kimberly L. Otto/Aaron G. Otto
- Moon Valley Natural Products LLC
3288 Valley Highway
Deming, WA 98244
- Issuing Office:
- Seattle District Office
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Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
August 11, 2017
In reply refer to Warning Letter SEA 17-20
Kimberly L. Otto, Owner
Aaron G. Otto, Owner
Moon Valley Natural Products, LLC
dba Moon Valley Organics
3288 Valley Highway
Deming, Washington 98244
Dear Mr. and Mrs. Otto:
This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 3288 Valley Highway, Deming, Washington, from February 14, 2017, through February 28, 2017, and collected finished product labeling, and subsequently reviewed your website at the Internet address www.moonvalleyorganics.com
. We determined that you take orders there for the products Muscle Rub, Rejuvenating Rub, PsoriaSoothe, Herbal Heal, and Peppermint Foot Rub. The claims on your website establish that the 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 can find the Act and the 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:
- “[D]eeply penetrate into muscles and joints to warm and comfort sore areas”
- “Massage into over-taxed muscles, sprains, strains, arthritic joints, or any other aches and pains…”
- “[D]eeply penetrate into sore muscles and joints to warm and comfort sore areas”
- “[D]eeply penetrate into sore muscles and joints to stimulate circulation and relieve minor aches and pains.”
- “[T]emporary relief to minor aches and pains and bruised areas”
- “[R]elaxing the body from throbbing head to aching toe”
- “Great for relieving headaches…”
Box Label and Product Brochure:
- “[S]oothe itchy, dry and flaking skin”
- “[S]oothe itchy, dry and flaking skin”
Furthermore, the product name “PsoriaSoothe” suggests the product is intended for psoriasis.
- “Our Recipe for Tending Damaged Skin”
- “…recuperating cuts, minor burns and abrasions”
- “…soothe…recuperating cuts, minor burns and abrasions. Sting free!”
- “Our Recipe for Tending Minor Wounds”
- “[S]oothe recuperating cuts, minor burns and abrasions”
- “It is free of any stinging ingredients…”
- “Apply to affected area of minor cuts, burns and infections. Great for healing tattoos…”
Peppermint Foot Rub
- “[S]oothe skin inflammation…”
- “[P]ain-relieving and anti-inflammatory…”
- “Massage into sore areas of your feet…”
Your website page, “All About Herbs” makes claims about several ingredients including lavender, arnica, and calendula, that are used in your cosmetic products. The claims regarding these ingredients are attributable to any products that contain the ingredients. For example, claims made regarding arnica on your website www.moonvalleyorganics.com/blogs/all-about-herbs
- “[U]sed to treat uterine hemorrhage, myocarditis, angina pectoris, and cardiac insufficiency.” These claims, and any potential violations relating to them, would apply to any product containing arnica.
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
- Review by customer on 02/03/17, “I have osteoarthritis and when my knees or feet are aching…just rub it on & it instantly takes the pain…away”
- Review by customer on 01/02/17, “I always look for products that help stimulate circulation. It is important for the diabetic in my life.”
- Review by customer on 01/02/17, “I used the foot rub on my boyfriend who needs…care on his feet and legs (from diabetes 1)…”
- Review by customer on 12/06/16, “I suffer from TMJ it’s a muscle disorder and I would be in debilitating pain if it wasn’t for this cooling rub”
- Review by customer on 04/14/17, “Soothed my sunburn and my psoriasis”
Your 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), 335(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the 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 Muscle Rub and Rejuvenating Rub are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Muscle Rub and Rejuvenating Rub fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 321(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 301(a) of the Act [21 U.S.C. § 331(a)].
We received your letter on March 21, 2017, which responded to our Inspectional Observations (Form FDA 483), issued at the close of our inspection on February 28, 2017. Your letter will be made part of your firm’s establishment file. The changes you have proposed or have made do not relate to the violations described and will be evaluated during a subsequent inspection.
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 the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations 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 correct the 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 fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be sent to Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian by telephone at 425-302-0444.
Miriam R. Burbach