WARNING LETTER
Natures Boost LLC
MARCS-CMS 609846 —
November 20, 2020
Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Nathan Howerton and Tanner Vaughn
Recipient Title
Member(s)
Natures Boost LLC
9805 Northeast 116th Street, Suite A312
Kirkland
,
WA
98034
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
November 20, 2020
In reply, refer to CMS 609846
WARNING LETTER
Dear Mr. Howerton and Mr. Vaughn:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet addresses www.natures-boost.com and www.bloodboostformula.com in June, July and November 2020, and has determined that you take orders there for the products “Blood Boost Formula” and “Turmeric Curcumin”. The claims on your websites establish that these 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 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:
Blood Boost Formula
Statements referring to Blood Boost Formula on www.bloodboostformula.com:
“[I]ngredients inside the Blood Boost Formula have been studied for their effect on healthy cholesterol levels without the nasty side effects you see with statins.”
Turmeric Curcumin
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 from Roberta on August 21, 2019, at https://naturesboost.com/collections/frontpage/products/turmeric-boost-formula: “I have had chronic pain for 16+ years. I have has [sic] 3 back surgeries, total knee replacement and fibromyalgia. I started this product just recently and in 3 days I can more effectively move my back with a HUGE decrease in pain.”
Review from Charlie on August 21, 2019, at https://naturesboost.com/collections/frontpage/products/turmeric-boost-formula#shopifyproduct-reviews: “I use this along with fish oil as an anti-inflammatory for osteoarthritis in both knees and hip. I’ve had no flare-ups for some time now.”
Review from Linda on August 21, 2019, at https://naturesboost.com/collections/frontpage/products/turmeric-boost-formula#shopifyproduct-reviews: “I had been having constant shoulder pain for over a month which is a recurring event for past 4-5 years. No amount of ibuprofen was helping this time and I was taking 600mg caps. Desperate for relief I decided to try the Turmeric. After a few days on this I noticed a marked improvement. Within a week or so I had full use of my arm again.”
Your “Blood Boost Formula” and “Turmeric Curcumin” 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 the 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 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 “Turmeric Curcumin” product is intended for prevention or 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, your “Turmeric Curcumin” product fail to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
This letter is not intended to be an all-inclusive review of your website and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct 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 promptly correct the violations specified above may result in legal action without further notice, including seizure of violative products and/or 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 above 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. 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: CDR Joshua Wireman, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact CDR Joshua Wireman at
425-302-0345
.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
cc: Nathan Howerton, Member
Tanner Vaughn, Member
Nature’s Boost LLC
17146 Beaton Road SE
Suite 5
Monroe, Washington 98272
Content current as of:
12/08/2020
Regulated Product(s)
Drugs
Food & Beverages