WARNING LETTER
Fresh Nutrition Inc
MARCS-CMS 612984 —
May 27, 2021
Delivery Method:
United Parcel Service
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Ms. Angela Duan
Recipient Title
Chief Executive Officer
Fresh Nutrition Inc
23860 Nicole Way
Yorba Linda
,
CA
92887-5626
United States
Issuing Office:
Office of Human and Animal Food Operations –West Division 5
United States
WARNING LETTER
WL 612984
Dear Ms. Angela Duan:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://fresh-nutrition.com in March and May 2021 and has determined that you take orders there for the products Berberine, Echinacea, European Elderberry, Milk Thistle, Lion’s Mane Mushroom, Turmeric Curcumin, Fish Oil, and Green Lipped Mussels.We have also reviewed your Amazon storefront which directs consumers to your Amazon product pages to purchase your products. Based on our review, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find links to the Act and applicable regulations on our website,
www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
The claims on your website and Amazon product pages establish that your Berberine, Echinacea, European Elderberry, Milk Thistle, Lion’s Mane Mushroom, Turmeric Curcumin, Fish Oil and Green Lipped Mussels products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, 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.
Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include:
On your Berberine product page at https://fresh-nutrition.com/products/berberine-90-capsules:
“Berberine is well regarded for its broad antibacterial, antimicrobial and anti-inflammatory properties.”
On your Echinacea product page at https://fresh-nutrition.com/products/echinacea-90-capsules:
“Widely used to prevent the common cold, Echinacea has been used for hundreds of years as a natural pain reliever. Certain studies have linked Echinacea to … relieve symptoms of anxiety and depression.”
“Relief from Common Cold and Flu, Natural Pain Reliever, Mental Health, Anxiety, Depression, Antibiot [sic] Properties, Fight Infections… Inflammation”
On your European Elderberry product page at https://fresh-nutrition.com/products/elderberryimmune-support-90-capsules:
On the picture of your product label: “Elderberry is the top antiviral herb on the planet. … Research shows that elderberry is a safe, efficient, and cost-effective treatment for cold and flu symptoms. When it comes to colds, flu … elderberry is very popular.”
“In addition to suppressing influenza viruses and relieving cold symptoms, Elderberry...”
On your Milk Thistle product page at https://fresh-nutrition.com/products/milk-thistle-120-servings-of-2000mg-best-for-liver-cleanse:
“Milk Thistle is… acknowledged for its ability as an anti-inflammatory, to assist with side effects during cancer treatments, protect from bone loss”
“When overconsumption of alcohol, an antioxidant called Glutathione becomes depleted leading to common symptoms of a hangover. Taking Milk Thistle helps replenish your Glutathione levels by protecting your liver cells by reducing inflammation and repairing the damage, and speeding up the recovery time.”
On your Lion’s Mane Mushroom product page at https://fresh-nutrition.com/products/lionsmane-mushrooms-90-capsules:
“Lions Mane Mushrooms have been shown to have many benefits, mainly improved cognitive function and brain health caused through regeneration, remyelination and increased nerve growth factor (NGF). They are used to… give relief from gastritis while being… anti-inflammatory… and improving lipid profile.”
On your Turmeric Curcumin product page at https://fresh-nutrition.com/products/turmeric-curcumin-best-natural-joint-pain-relief:
On the picture of your product label: “Curcumin… have been shown to have antiinflammatory… benefits”
“…our Turmeric Curcumin Supplement has been proven to reduce pain and inflammation, regulate blood pressure, clotting & cholesterol levels, bone density … and multiply Brain-Derived Neurotropic Factor (BDNF) protein in your brain. BDNF can help fight against age-related brain diseases, … and balance Serotonin & Dopamine levels helping with anxiety and depression.”
“Boswellia Serrata Extract 65% [an ingredient in your Turmeric Curcumin product] has been a potential anti-inflammatory agent for years. It has been are [sic] most commonly used for chronic inflammatory ailments. Based on the recent scientific research, natural anti-inflammatory herbs, including Turmeric and Boswellia, may work as well as aspirin and ibuprofen for treating osteoarthritis. Boswellia has been investigated for its benefits in osteoarthritis (OA), and it appears that oral Boswellia supplements can suppress pain and immobility associated with OA quite significantly taking as little as a week to start improving.”
On your Fish Oil product page at https://fresh-nutrition.com/products/fish-oil-75-capsules:
“[Fish oil is] rich in omega-3 fatty acids which are important in preventing and managing heart disease. Studies have shown that fish oil may help lower blood pressure.”
On your Green Lipped Mussels product page at https://fresh-nutrition.com/products/greenlipped-mussel-90-capsules:
“Main benefits are… joint pain, range of motion, … inflammation, arthritis”
On the picture of your product label: “These nutrients [in Green Lipped Mussels] have been shown to ease joint pain”
Furthermore, you operate an Amazon storefront under the name Fresh Nutrition. We reviewed your product listings for Berberine, Echinacea, Elderberry Immune Support, Milk Thistle, Lion’s Mane Mushroom, and Green Lipped Mussels. Examples of some of the claims observed that provide evidence that your products are intended for use as drugs include:
On your Berberine Amazon product page at https://www.amazon.com/Berberine-500mg-Added-Chromium-Gastrointestinal/dp/B086J6YNLH/:
“Fresh Nutrition Berberine and Chromium Benefits? … lower blood sugar and cholesterol … natural support to women with PCOS by regulating insulin and glucose levels.”
On your Echinacea Amazon product page at https://www.amazon.com/Echinacea-Strongest-Conditions-Depression-Infections/dp/B07WSRFHTZ/:
“Echinacea… Pain Reliever, Anxiety, Depression, Fight Infections”
“Fresh Nutrition Echinacea Benefits? … Natural Pain Reliever… Anxiety, Depression, Antibiot [sic] Properties, Fight Infections… Inflammation…”
On your Elderberry Immune Support Amazon product page at https://www.amazon.com/Elderberry-Immune-Support-Strongest-Verified/dp/B086RRMWSK:
“Fresh Nutrition Elderberry Benefits? … Antibiot [sic] Properties, Fight Infections…”
On your Milk Thistle Amazon product page at https://www.amazon.com/Milk-Thistle-Organic-Sylimarin-Standardized/dp/B01NC34QAX:
“Cure Your Hangover Fast; Milk Thistle … helps speed up the recovery process for your liver, getting rid of your hangover faster!”
“Taking the product on a regular basis before drinking may also aid in reducing the possibility of a hangover in the morning.”
On your Lion’s Mane Mushroom Amazon product page at https://www.amazon.com/Mushroom-Capsules-Strongest-1500mg-Special/dp/B07BD3DHZG/:
“Lions Mane Mushrooms have been shown to have many benefits, mainly improved cognitive function and brain health caused through regeneration, remyelination and increased nerve growth factor (NGF). They are used to… give relief from gastritis while being… anti-inflammatory… and improving lipid profile.”
On your Green Lipped Mussels Amazon product page at https://www.amazon.com/Green-Lipped-Mussel-Capsules-Canaliculus/dp/B07WTQ6W5S/:
“Green Lipped Mussel Capsules … for Hip and Joint Relief – Joint Pain Supplement”
“Main benefits are… joint pain, range of motion, … inflammation, arthritis”
On the picture of your product label: “These nutrients [in Green Lipped Mussels] have been shown to ease joint pain”
Your Berberine, Echinacea, European Elderberry, Milk Thistle, Lion’s Mane Mushroom, Turmeric Curcumin, Fish Oil and Green Lipped Mussels products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions 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), 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 Berberine, Echinacea, European Elderberry, Fish Oil, Lion’s Mane Mushroom, Milk Thistle, and Turmeric Curcumin 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 products Berberine, Echinacea, European Elderberry, Fish Oil, Lion’s Mane Mushroom, Milk Thistle, and Turmeric Curcumin 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)].
Unapproved New Animal Drugs
During our review of your website (https://fresh-nutrition.com) and Amazon product pages, FDA determined that your Green Lipped Mussels product is also intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes it a drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the Act.
Examples of claims observed on your website (https://fresh-nutrition.com) that establish the intended use of your product as a drug include:
On your Green Lipped Mussels product page at https://fresh-nutrition.com/products/greenlipped-mussel-90-capsules:
“Great for dogs and humans alike! Main benefits are… joint pain, range of motion, … inflammation, arthritis”
On the picture of your product label: “These nutrients [in Green Lipped Mussels] have been shown to ease joint pain”
Furthermore, you operate an Amazon storefront under the name, Fresh Nutrition. We reviewed your product listings for Green Lipped Mussels. Examples of claims observed that establish the intended use of your products as drugs include:
On your Green Lipped Mussels Amazon product page at https://www.amazon.com/Green-Lipped-Mussel-Capsules-Canaliculus/dp/B07WTQ6W5S/:
“Green Lipped Mussel Capsules … for Hip and Joint Relief – Joint Pain Supplement”
“Great for dogs and humans alike! Main benefits are… joint pain, range of motion, inflammation, arthritis”
On the picture of your product label: “These nutrients [in Green Lipped Mussels] have been shown to ease joint pain”
Based on our review, this product is a "new animal drug" under section 201(v) of the Act [21 U.S.C. 321(v)] because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. New animal drugs that are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing are unsafe under section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction of these products into interstate commerce is prohibited under 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 and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will do so.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612
Refer to Unique Identification Number 612984 when replying.
If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5
Content current as of:
06/22/2021
Regulated Product(s)
Animal & Veterinary
Food & Beverages