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August 26, 2020

WARNING LETTER

Refer to CMS 606456

Dear Mr. Hudlow:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your product labeling for Antiiva and LungRenew following an inspection of your facility located at 4832 Park Glen Road, Minneapolis, Minnesota, between December 12 and 31, 2019. Between February and June 2020, we also reviewed your product catalog, mailers for Antiiva and LungRestore, and your social media website, https://www.facebook.com/pages/category/Health---Wellness-Website/Hampshire-Labs-Inc-291271177574079/, where you direct consumers to your website, http://www.hampshirelabs.com/, to purchase your products. The claims on your product labeling establish that the Antiiva, LungRenew, and LungRestore 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’s regulations through links on FDA’s home page at http://www.fda.gov.

Examples of some of the claims on your product labeling that provide evidence that these products are intended for use as drugs include:

Antiiva

Antiiva Pamphlet “Medical Health News For Men”:

• “2 Times More Prostate Shrinking Beta-Sitosterol [ingredient in Antiiva]”
• “Improves prostate symptoms by 353%”
• “These 18 European Studies Prove This Nutrient Will Relieve Your Prostate Problems Fast. There are dozens of double blind studies done with men regarding the effects of beta-sitosterol on an enlarged prostate (Note: An enlarged prostate is known medically as BPH or benign prostate hypertrophy).”
• “. . . beta-sitosterol would appear to be a useful therapeutic tool in the treatment of an enlarged prostate”
• “It has been shown in studies to relieve urinary symptoms from an enlarged prostate”
• “[B]eta-sitosterol is the most promising of all medical therapies”
• “That’s exactly what the prostate supplement Antiiva does! It is the proven prostate protector that can FREE YOU FROM PROSTATE PROBLEMS IN JUST DAYS . . . and that every man like you and me over 50 should be taking every day. By addressing the REAL CAUSE of your prostate problems, it relieves your nighttime urination and fights inflammation that causes your problems.”
• “By shrinking your prostate back to its normal and healthy size, Antiiva helps restore you to normal urinary and sexual function. . .”
• “Selenium [ingredient in Antiiva] is known to help slow the production of PSA and also help reduce the symptoms of an enlarged prostate”
• “[Z]inc [ingredient in Antiiva] . . . helps reduce symptoms of BPH”

Mailer:
• “It’s been awhile since you last ordered Antiiva. . . Are you running low? You sure don’t want to have a break in the relief of your enlarged prostate symptoms. You don’t want to go back to those frequent bathroom trips and that feeling of always having to go. You know all the signs.”

LungRestore

Hampshire Labs Facebook page:
• March 29, 2018 posting: “Yes, it should help with COPD and it is only available through Hampshire Labs, direct.”
• March 23, 2018 posting with a LungRestore infographic, which states:
  o “BREATHE EASIER With NO drugs, high cost or side effects. Even if you have allergies, bronchitis or emphysema!”
  o “Fight off viral and bacterial infections”

Mailer:
• “Hopefully, by now you’re breathing easier with LungRestore. Even if you have asthma, allergies, bronchitis or emphysema, LungRestore can help without the side-effects of over the counter drugs!”

LungRenew

LungRenew Pamphlet “Lung and Breathing News”:
• “BREATHE EASIER with NO DRUGS, high cost or side effects. Even if you have asthma, allergies, bronchitis or emphysema!”
• “FIGHT OFF viral and bacterial infections”
• “For U.S. Citizens Who Have Any of the Following Health Problems. . .asthma
. . .allergies. . .sinusitis. . .bronchitis. . .obstructive lung issue. . .Or if you are taking an inhaler, anti-inflammatory shots or STEROIDS. . . LungRenew works for you.”

Product catalog:
• “LungRenew can help you breathe easier even if you have asthma, bronchitis, or emphysema. This all-natural cleanser relaxes, purifies and strengthens your lungs.”

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) and 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 products Antiiva, LungRestore, and LungRenew 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, these 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).

The violations cited in this letter are not intended to be an all-inclusive list 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 ensure that your firm complies with all requirements of federal law, including 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.

We offer the following comments regarding your compliance with the labeling regulations for dietary supplements, 21 CFR Part 101:

1. Your Hampshire Labs, Inc. brand Antiiva and Worldwide Herbals brand Holy12 product labels do not declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
  a. The Hampshire Labs, Inc. brand Antiiva product label declares “Beta Sitosterol Complex” but fails to list all (b)(4) of the complex’s sub-ingredients.
  b. The Worldwide Herbals brand Holy12 product label declares the dietary ingredient banaba. This botanical is not listed in the reference Herbs of Commerce; therefore, the product label must state the Latin binomial name of the plant in accordance with 21 CFR 101.4(h)(2).

2. Your Worldwide Herbals brand Holy12 product labels do not identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 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 Dianna Sonnenburg, Compliance Officer, at the address listed on the letterhead, Office of Human and Animal Food Operations West, Division 1, Food and Drug Administration. If you have any questions about the content of this letter, please contact Ms. Sonnenburg at (612) 758-7125 or e-mail at dianna.sonnenburg@fda.hhs.gov.

Sincerely,
/S/

Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations