Labeling and packaging Findings

FDA Review Violations were identified and documented during review of the product labeling of products purchased on your website www.walmart.com in July 2026. FDA purchased, “HClear for him,” “Herstat GST,” and “Terragen HG Formula” through your website, and these products were introduced or delivered for introduction into interstate commerce by Walmart via your Walmart Fulfillment Services. 1 Based on our review, “HClear for him,” “Herstat GST,” and “Terragen HG Formula” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “HClear for him,” “Herstat GST,” 2 and “Terragen HG Formula” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims observed on the product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: HClear for him “GENITAL HERPES SYMPTOMS” “>90 of USERS REPORTED LESS SEVERE OUTBREAKS” “FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING” “[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.” “[B]est used at first sign of outbreak. Early use ensures the best results.” Herstat GST “Genital Sore Treatment” “Soothes and calms genital sores” “[R]elieves pain and itching associated with genital sores.” Terragen HG Formula “Uses . . . relief of swelling and pain associated with genital sores.” “HClear for him,” “Herstat GST,” and “Terragen HG Formula” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). We recognize that the “Terragen HG Formula” product available for purchase on your website is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval. 3

FDA Review Violations were identified and documented during a review of your website https://www.aidanceproducts.com/ and your Amazon storefront 1 in July 2026. Based on our review, “Terragen HG Formula” is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website and Amazon storefront, “Terragen HG Formula” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website and Amazon storefront, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following: On the webpage www.aidanceproducts.com, consumers can “Shop by Condition” and select “Herpes,” which redirects to your Amazon storefront page for “Terragen HG Formula.” On the webpage https://www.amazon.com/Terragen-HG-Formula-Max-Sufferers/dp/B06XT8CWCC/?th=1: “Genital sores treatment, outbreak support” “FAST RELIEF & SOOTHING OINTMENT: . . . treatment cream relieves genital sores and symptoms including tingling, itch, irritation, redness, pain and inflammation. Provides relief quickly with natural, soothing ingredients. For men and woman, for daily use. Discreet packaging.” “EFFECTIVE PROTECTION & HEALING: Terragen HG MAX . . . to protect the genital area from irritation and support natural healing.” “Product description . . . o Herpes Sores o Stinging Pain” On Drug Facts image: o “[R]elief of swelling and pain associated with genital sores.” “Terragen HG Formula” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). We recognize that your “Terragen HG Formula” product is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

A drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner. You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for their intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.onlinegenericmedicine.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act. Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug product without requiring a prescription, www.onlinegenericmedicine.com jeopardizes patient safety and misbrands the drug product under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.

FDA Review Violations were identified and documented during a review of your websites, https://drsosnowski.com/ and https://www.herstat.com/ in July 2026. We have also reviewed your Facebook and Instagram accounts at https://www.facebook.com/DoctorSosnowski and https://www.instagram.com/drsosnowskis/ where you direct consumers to your website to purchase your products. Based on our review, “Herstat GST” is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “Herstat GST” 1 is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following: On the webpage https://drsosnowski.com/products/herstat-gst: On product label: “Genital Sore Treatment” “Herstat GST provides rapid and targeted relief of genital sores at tingle, blister or scab, getting to work from 1st use at any stage of an outbreak” “The formula is dual action, designed to provide effective relief of symptoms (itching, pain, irritation) and aid healing of skin during outbreaks by calming inflammation and balancing PH” On the webpage https://www.herstat.com/products/herstat-genital-sore-treatment?variant=52463728689494: “Dr Sosnowski’s Herstat GST is formulated to provide effective relief from the symptoms of genital sores.” “The carefully balanced formula of GST helps to soothe and calm the symptoms of genital sores and provides temporary relief of pain, itching and inflammation.” “Effective for the treatment of genital sores” On an October 12, 2022 post on your Facebook and Instagram page https://www.facebook.com/DoctorSosnowski and https://www.instagram.com/drsosnowskis/ respectively: On product label: “Genital Sore Treatment” “Herstat GST provides rapid, targeted relief from the symptoms of genital sores.” “[P]rovides targeted pain relief . . . soothing relief to calm the discomfort associated with genital sores.” . . . “[A]nalgesic action . . . penetrate deep into the epidermis.” “Herstat GST” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

FDA Review Violations were identified and documented during review of the product labeling of products purchased on your website www.amazon.com in July 2026. FDA purchased, “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” through your website and these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service. 1 Based on our review, “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of the product labeling, “FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” 2 “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims observed on the product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: FemiClear “Genital Herpes Symptoms” “Fast-acting ointment for recurring outbreak symptoms” “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS” “[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.” “[B]est used at first sign of outbreak. Early use ensures the best results.” HClear for him “GENITAL HERPES SYMPTOMS” “>90 of USERS REPORTED LESS SEVERE OUTBREAKS” “FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING” “[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.” “[B]est used at first sign of outbreak. Early use ensures the best results.” HerpCare Ointment “FAST-ACTING GENITAL HERPES SYMPTOM RELIEF” “Soothes and calms genital sores” “Purpose: o Anti-Fungal o Anti-microbial” “Provides temporary relief from skin inflammation, irritation, and/or tingling caused by genital herpes.” HerpCare Spray “Relief on the Go: o Fast-acting formula in a convenient spray format . . . o Herpes Symptoms” “To maintain optimal hygiene and support skin health, incorporate the HerpCare Genital Wash into your daily routine. Formulated specifically for sensitive skin, it helps maintain a balanced environment and supports the natural healing process . . . help manage symptoms effectively throughout the day and night.” “Gentle & effective care for intimate areas” “Soothes irritation, burning & itching quickly” Genital Herpes Intimate Wash “Formulated for Herpes Relief” “Antiviral Action . . . reduce viral activity . . . powerful antimicrobial properties” “Pain Relief . . . numbs pain and soothes itching by targeting nerve endings, providing fast and lasting relief during flare-ups” “Anti-Inflammatory . . . reduce redness, swelling, leaving your skin feeling refreshed.” “Healing Support . . . hydrates and promotes skin repair, aiding in faster recovery” Herstat GST “Genital Sore Treatment” “Soothes and calms genital sores” “[R]elieves pain and itching associated with genital sores.” Genital Herpes Ointment “FAST ACTING GENITAL HERPES RELIEF” “Soothes Genital Sores.” “Purpose: o Anti-Fungal o Anti-Microbial” “[R]elief of inflammation, irritation, and tingling caused by genital herpes.” RoyceDerm Herpes Relief Cream “Helps relieve the symptoms of rashes or blisters, itchy, redness and pain.” “FIGHTS OUTBREAKS” “SOOTHES & COOLS” “REDUCES RECURRENCE” “[S]pecifically formulated to help relieve the symptoms of Herpes, rashes or blisters, redness & pain.” Terragen HG Formula “Uses . . . relief of swelling and pain associated with genital sores.” “FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). We recognize that the “Terragen HG Formula” product available for purchase on your website is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval. 3

FDA Review Violations were identified and documented during a review of your website https://femiclear.com/ in July 2026. We have also reviewed your Facebook and Instagram accounts at https://www.facebook.com/FemiClear and https://www.instagram.com/femiclear, respectively, where you direct consumers to your https://femiclear.com/ website to purchase your products. Based on our review, “HClear for him” and “FemiClear Genital Herpes Symptoms” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an allinclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “HClear for him” and “FemiClear Genital Herpes Symptoms” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website and social media accounts, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: HClear for him On the webpage https://femiclear.com/products/hclear-for-him-for-genital-herpes-symptoms-24-ea?selling_plan=3741548730: On the image of the product o “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS” o “GENITAL HERPES SYMPTOMS” o “FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING” “Try the FemiClear topical ointment for men that kills 99.9% of the herpes simplex I & II viruses” On a September 10, 2024, post on your Facebook page https://www.facebook.com/FemiClear/posts/pfbid02GZLSvy4rJUch7SvLwKcZbP8r5aAipKeCruw7qjkDnjKVLigQPhSu8i7CroLJf6cjl: “Say goodbye to the discomfort of genital herpes symptoms with HClear for Him! This all-natural, organic ointment is designed specifically for men, targeting itching, tingling, and burning caused by herpes outbreaks. With a powerful formula that kills 99.9% of herpes simplex viruses (HSV1 & HSV2), you can trust HClear to bring fast relief. Over 90% of users reported milder symptoms, and over 50% experienced no blisters when used at the first sign.” “Explore The Benefits HClear for Him for Genital Herpes Symptoms” FemiClear Genital Herpes Symptoms On the webpage https://femiclear.com/products/femiclear-herpes-treatment-multi3symptom?selling_plan=3740434618: On the image of the product o “Fast-acting ointment for recurring outbreak symptoms” o “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS” “Looking for genital herpes symptom relief? Try the FemiClear topical ointment that kills 99.9% of the herpes simplex I & II viruses (HSV1 & HSV2) and works fast to relieve Itching & Tingling + Pain & Burning symptoms caused by a herpes outbreak.” On a January 29, 2026, post on your Facebook page https://www.facebook.com/photo.php?fbid=1343141094494950&set=pb.100063972160769.-2207520000&type=3: On the image of the product o “GENITAL HERPES SYMPTOMS Fast-acting ointment for recurring outbreak symptoms” On an April 4, 2025, post on your Instagram page https://www.instagram.com/p/DICmMYfOANa/: “Herpes Relief for Less” “Genital Herpes Symptoms” “We know managing outbreak symptoms can be tough. The last thing you need is a price tag standing between you and relief. That’s why we dropped the price of FemiClear for Genital Herpes Symptoms.” Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include, but are not limited to, the following from the Reviews section of the “FemiClear Genital Herpes Symptoms” product webpage https://femiclear.com/products/femiclear-herpes-treatment-multisymptom?selling_plan=3740434618: “Works like magic! I have had genital herpes for 35 years, and in the past 15 years, the outbreaks have been horrible and hard to get rid of. I won't take meds because they mess up my stomach. However, this ointment effectively eliminates the blisters within 24 hours. I have tried EVERYTHING, and this product truly works.” “HClear for him” and “FemiClear Genital Herpes Symptoms” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. 1 Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).