WARNING LETTER
Natural Hope Herbals, LLC
MARCS-CMS 612467 —
June 10, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Benjamin L. Stoltzfus
Recipient Title
CEO
Natural Hope Herbals, LLC
670 Phillips Road
Millersburg
,
PA
17061-9044
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS #612467
June 10, 2021
Dear Mr. Stoltzfus:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.naturalhopeherbals.com in March 2021 and has determined that you take orders there for your Super Tonic, Respiratory Aid, Wild Cherry Honey Syrup, Ivy Oaky, Jewelweed Spray Combo Pack, Jewelweed Spray, Prostate Health, Kidney/Bladder, and Bone & Tissue Connect supplement products. 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 FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the claims observed on your website https://www.naturalho-peherbals.com that provide evidence that your products are intended for use as drugs include:
Super Tonic
Stated in your Autumn 2020 Newsletter, Maintaining Urinary health- https://naturalho-peherbals.com/wp-content/uploads/2020-NHH-autumn.pdf
• “At the first sign of infection, begin boosting your immune system and help your body fight possible infection. Be sure to consume sufficient water, add vitamin C, echinacea, and Super Tonic to your immune improving routine.”
Wild Cherry Honey Syrup
Stated in the Autumn 2020 Newsletter, Breath Easy: Herbal Support for Coughshttps://naturalhopeherbals.com/wp-content/uploads/2020-NHH-autumn.pdf
• “For dry coughs that need to be quelled, we carry a Wild Cherry Compound (both a regular formula and a Tasty formula for children) and a soothing Wild Cherry Honey Syrup.”
Ivy Oaky/Jewelweed Spray Combo Pack/Jewelweed Spray
On the product webpage- https://naturalhopeherbals.com/products/immune-system/ivyoaky-jewelweed-spray-combo-pack/
• “Jewelweed Spray…The perfect product to accompany Ivy Oaky. Jewelweed, the inspiration for this formula, is one of the most popular herbs for soothing summertime rashes.”
Stated in the Summer 2019 Newsletter, Your Herbal Aid Toolbox- https://naturalhopeherbals.com/wp-content/uploads/NHH-2019SummerNewsletterLGFinal.pdf
• “Ivy-Oaky and Jewelweed Spray are perfect for helping out with poison ivy and oak and other strange rashes that might happen. Keep them close by. Ivy Oaky is taken internally to support the healing process from the inside out.”
Prostate Health
On the product webpage- https://naturalhopeherbals.com/products/male-health/prostate-health/
• “Decreased prostate function (benign prostate hypertrophy) is a normal part of a man’s aging process”
Kidney/Bladder
Stated in the Autumn 2020 Newsletter, Maintaining Urinary Health- https://naturalhopeherbals.com/wp-content/uploads/2020-NHH-autumn.pdf
• “Kidney/Bladder and Stone Breaker (kidney stones) Compound formulas…For example, fresh corn silk is a soothing diuretic. Parsley leaf and root assists kidney stone and other kidney related complaints including pressure of the prostate gland (benign prostatic hyperplasia). Goldenseal increases kidney function and eases the irritated urinary system. Stinging nettle, an ideal urinary tonic, aids gravel in the kidneys and in kidney infections. It is a solvent to uric acid calculi deposits (kidney stones). Uva ursi…provides a slight a antiseptic effect on the mucous membranes. Juniper berry is included in the formula for its dynamic ability to increase urination and flush waste from the bloodstream.”
• “It is a great healer to the kidneys, urinary passages and bladder,” according to Dr. Christopher”.
Bone & Tissue Connect
Stated in the Winter 2019 Newsletter, Formula Spotlight- https://naturalhopeherbals.com/wp-content/uploads/NHH-20181120-Winter-2019-Newsletter_web.pdf
• “When desperate for pain relief, people are apt to take more than the suggested dose. The first five herbs are nourishing tonic herbs that provide minerals and other cofactors required for bone and other connective tissue healing”.
Your website also contains evidence of intended use in the form of a personal testimonial recommending or describing the use of Respiratory Aid for the cure, mitigation, treatment, or prevention of disease. An example of such a testimonial is included in the Summer 2019 Newsletter - https://naturalhopeherbals.com/wp-content/uploads/NHH-2019SummerNewsletterLGFinal.pdf.
• “I use Respiratory Aid all the time for whenever my daughter seems like she’s getting a bug…”
Your Super Tonic, Respiratory Aid, Wild Cherry Honey Syrup, Ivy Oaky, Jewelweed Spray Combo Pack, Jewelweed Spray, Prostate Health, Kidney/Bladder, and Bone & Tissue Connect supplement 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)]. With certain exception not applicable here, 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) and 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” mean 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 Prostate Health and Kidney/Bladder supplement products 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, your Prostate Health and Kidney/Bladder supplement products fail to bear adequate directions for their intended use and, therefore, the products are 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may 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 that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any 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 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.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 6000 Metro Drive, Suite #101, Baltimore, Maryland 21215. If you should have any questions regarding any issue in this letter, please contact Melissa B. Libby, Compliance Officer, or by e-mail to melissa.libby@FDA.HHS.GOV. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Melissa B. Libby at (973) 331-4997.
Sincerely,
/S/
Randy F. Pack
Program Division Director
Division Director
Human & Animal Food Division II East
Baltimore District Office
Content current as of:
07/13/2021
Regulated Product(s)
Food & Beverages