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  5. Nature Essence Small Molecule Co., LTD - 586327 - 02/12/2020
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WARNING LETTER

Nature Essence Small Molecule Co., LTD MARCS-CMS 586327 —

Delivery Method:
United Parcel Service
Product:
Cosmetics
Recipient:
Recipient Name
Lifang Zheng
Recipient Title
Owner
Nature Essence Small Molecule Co., LTD

3475 Lyon Drive Apartment 62
Lexington, KY 40513-1132
United States

Issuing Office:
Division of Human and Animal Food Operations East V

United States

February 12, 2020

WARNING LETTER 586327


Dear Ms. Zheng:

The U.S. Food and Drug Administration (FDA) inspected your establishment at 3475 Lyon Drive, Apartment 62, Lexington, Kentucky, on May 6, 14, and 20, 2019. Based on a review of your ready-to-eat, raw, fermented product manufacturing and product labels collected during the inspection and a subsequent review of your emails to the FDA, we have identified serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. The claims on your product labels establish that your “Fruit Enzyme,” “Ginkco (sic) Enzyme,” and “Saponin Enzyme” (aka “Soap Enzyme”), products are unapproved new drugs. Your email claims establish that your Saponin (or Soap) Enzyme, “Environmental (Clean) Enzyme,” and “Bath Enzyme” products are drugs. Furthermore, your products are misbranded drugs under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Even if these products were not drugs, your Fruit Enzyme, “Edible Enzyme,” and Ginkco (sic) Enzyme products would be misbranded foods within the meaning of section 403 of the Act [21 U.S.C. § 343], and your Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products would be misbranded cosmetics within the meaning of section 602(b) of the Act [21 U.S.C. §362(b)]. Additionally, based on FDA’s inspectional findings, we determined that the food products manufactured in your establishment are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] and that the cosmetic products manufactured in your establishment are adulterated within the meaning of section 601(c) of the Act [21 U.S.C. § 361(c)]. It is a violation of section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a food, drug, or cosmetic that causes that product to become adulterated or misbranded while it is held for sale after the shipment of one or more of its components in interstate commerce. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New / Misbranded Drugs

FDA reviewed labels for your “Fruit Enzyme”, “Ginkco (sic) Enzyme”, and “Saponin Enzyme” (aka “Soap Enzyme”) products following the inspection at your establishment. The claims on your product labels establish that the 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 cure, mitigation, treatment, or prevention of disease.

Examples of some of the claims that establish your products are intended for use as drugs include, but may not be limited to, the following:

Fruit Enzyme

o “[D]rinking Fruit Enzyme to . . . treat cardiovascular disease, high blood pressure, high blood sugar and high blood lipids, as well as having anti-inflammatory properties...”

Ginkco (sic) Enzyme

o “[D]rinking and applying Ginkgo Enzyme to the skin to treat tuberculosis, E. coli., skin fungus, skin disease, muscle pain, bone pain, headaches, colds, respiratory disease, and acute gastroenteritis…”

o “A small amount of drinking can effectively treat colds, respiratory diseases, acute gastroenteritis. Drink one spoon each morning and evening. Depends on the situation you can take until the illness disappears.”

o “[F]or muscle, bone painful spray or use it like lotion on pain place do it until pain gone”

o “Ginkgo effect: It can kill tuberculosis, Escherichia coli, skin fungus, 88%-100% of apple anthracnose, etc., effectively remove various skin diseases, small molecules of enzymes, decomposition function, deep penetration and remove muscle pain. Bone headache substances, etc., relieve muscles, bone headache.”

o “Usage: Spray or smear on the affected area, continue to adhere, such as applying more than 2 times a day, if the condition is heavier, apply more to the affected area until the disease is eliminated, no side effects.”

Saponin Enzyme (also known as Soap Enzyme)

o “[N]o itching, no dandruff!”

Your Fruit Enzyme, Ginkco (sic) Enzyme, and Saponin Enzyme 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)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. No FDA approved applications are on file for these products.

In addition, a review of your emails to the FDA establish that your Saponin (or Soap) Enzyme, Environmental (Clean) Enzyme, and Bath Enzyme 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 cure, mitigation, treatment, or prevention of disease. Examples of some of the email claims that provide evidence that your products are intended for use as drugs include:

Saponin Enzyme (also known as Soap Enzyme)

o “For skin: deeply sterilize; relieve skin itching, sores, inflammation, ulcer, and lesion. Improve the immune system. anti-lesion, see relevant research report, as well as anti-cancer and improve immunity of AIDS.”

o “[A]nti-itching, and remove dandruff.”

Environmental (Clean) Enzyme

o “Brushing your teeth: Each time you brush your teeth, drop 1-3 drops of enzyme on your toothpaste to remove dental stains, remove calculus, and reduce dental disease.”

Bath Enzyme

o “For the health care of ordinary people, adding 50ML in water can effectively help remove toxins, kill the skin's Candida and other bacteria, and make the skin soft and shiny.”

o “Full-enzyme bathing, for critically ill patients, for example, cancer patients, when eating is more difficult, choose a bath to pass the skin to let the enzymes enter the body, help the body function recovery, the skin has a filtering function, so that patients can safely let Enzymes enter the body, bathing requires a lot of enzymes, enzymes are widely produced, there are peels, pine needles, wild leaves, edible vegetables, brown sugar, water, sealed fermentation for more than 3 months, preferably more than 6 months, in In [sic] China, we have already seen some cancer patients get medical treatment. They don't need surgery to cut them off. They don't need chemotherapy. After a few months, they insist on bathing for half an hour to an hour every day. The tumors become bigger and smaller, slowly disappear and return to health.”

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 Fruit Enzyme, Ginkco (sic) Enzyme, Saponin (or Soap) Enzyme, Environmental (Clean) Enzyme, and Bath Enzyme products are intended for treatment of one of 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, Fruit Enzyme, Ginkco (sic) Enzyme, Saponin (or Soap) Enzyme, Environmental (Clean) Enzyme, and Bath Enzyme fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. It is also a violation of section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a drug that causes the drug to become misbranded while it is held for sale after the shipment of one or more of its components in interstate commerce.

Adulterated Food Products

Even if your products did not have claims that make them drugs, they would still be adulterated foods. Your Fruit Enzyme, Ginkco Enzyme, and Edible Enzyme ready-to-eat, raw, fermented food enzyme products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby the food products may have become contaminated with filth, or whereby they may have been rendered injurious to health. During our inspection of your establishment, FDA investigators found violations of the Current Good Manufacturing Practice regulations for human foods under 21 CFR Part 117, subpart B. The significant violations are as follows:

1. You do not employ appropriate quality control operations to ensure that your food is suitable for human consumption, as required by 21 CFR 117.80(a)(2). Specifically, none of your ready-to-eat, raw, fermented food enzyme products (your Fruit Enzyme, Ginkco Enzyme, and Edible Enzyme products) are manufactured using a planned and systematic procedure for taking all actions necessary to prevent these products from being adulterated. There is no consistency in the length of fermentation or amount and types of fruits and other plant material used for each batch of the same products. Using different types and amounts of fruits and plant material with varying sugar compositions and acidity in the production of fermented foods could affect the initial pH and sugar content, as well as other parameters of the mixture, which could allow for pathogenic microbial growth.

Also, your ready-to-eat, raw, fermented food enzyme products are manufactured with raw materials, such as (b)(4) and (b)(4), which were all collected from local roadsides, parks, and neighborhoods. You did not determine that the raw materials are clean and suitable for processing into food, or that they do not contain levels of microorganisms that may render the food injurious to the health of humans, as required by 21 CFR 117.80(b).

2. You do not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b). Specifically, during the filtration step of your ready-to-eat, raw, fermented Fruit Enzyme product, on May 14, 2019, our investigator observed that you did not wash your hands prior to dipping your bare hands into batches of raw product, which you scooped out with what appeared to be an unwashed plastic beverage container and poured into a paper-lined sieve placed over a plastic bucket. Further, you did not wear a hair net during any of the observed filtration operations.

3. You do not clean and sanitize your utensils or food-contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and contamination of food, as required by 21 CFR 117.35(d). Specifically, our investigator observed that you used discarded plastic buckets from local restaurants—many of which were used to store allergens such as soy sauce—in the manufacturing of your ready-to-eat, raw, fermented food enzyme products. Your process for preparing these buckets for use in fermentation of your enzyme products does not involve a sanitization step or a proper cleaning step. Moreover, the cleaning solution you used on May 14, 2019, to clean a bucket for use in fermentation, was a mixture of (b)(4). You did not verify that this cleaning solution is free from undesirable microorganisms and is a safe and adequate cleaning solution, as required by 21 CFR 117.35(b).

4. You do not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas of your establishment and to protect against contamination of food by pests, as required by 21 CFR 117.35(c). Specifically, on May 14, 2019, our investigator observed apparent fruit flies on finished bottles of enzyme product and on an open jar of liquid in your manufacturing area. The fruit flies were flying around open buckets of fermenting product during (b)(4) testing and flying around the open buckets and equipment used during the (b)(4) process of your Fruit Enzyme product.

5. You do not maintain your establishment in a clean and sanitary condition, as required by 21 CFR 117.35(a). Specifically, on May 14, 2019, during the manufacturing of ready-to-eat, raw, fermented food enzyme products, our investigator observed uncleaned, open food containers and cooking equipment for personal use throughout the kitchen area and near the sink where a bucket was being cleaned for use in fermentation of your enzyme products. You informed the investigator this is where you mix all the raw materials for fermentation.

Cosmetic Adulteration

Even if your products were not drugs, they would still be adulterated cosmetics. Under section 201 of the Act [21 U.S.C. § 321(i)], cosmetics are defined as: "(I) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof, for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap." Under Section 601(c) of the Act [21 U.S.C. § 361(c)], a cosmetic is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

During the inspection, our investigator observed and documented insanitary conditions whereby your “Saponin Enzyme,” “Environmental (Clean) Enzyme” and “Bath Enzyme” products may have become contaminated with filth or rendered injurious to health. Specifically, there was apparent filth on manufacturing equipment and insect contamination in the production area. For example, we noted the following:

• Insect contamination was observed in the processing area. The investigator observed fruit flies in the processing area and flying around open buckets of fermenting product during (b)(4) testing.
• Holding/fermentation containers were encrusted with old material residues and not adequately maintained, cleaned, sanitized and/or sterilized. Further, the investigator noted the equipment is not sanitized prior to use.

Food Misbranding

Moreover, even if your products were not drugs, they are misbranded foods.

1. Your Fruit Enzyme, Edible Enzyme, and Ginkco (sic) Enzyme products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Further, your products are not consistently made with the same ingredients and may include local seasonal flora.

2. Your Fruit Enzyme, Edible Enzyme, and Ginkco (sic) Enzyme products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).

3. Your Fruit Enzyme, Edible Enzyme, and Ginkco (sic) Enzyme products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7.

Cosmetic Misbranding

Furthermore, even if your products were not drugs, they are misbranded cosmetics.

1. Your Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products are misbranded within the meaning of section 4 of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. 1454(c)(3)(B)] in that the products are not labeled with a statement of identity which is the common or usual name of the cosmetic; is an appropriately descriptive name or, when the nature of the cosmetic is obvious, a fanciful name understood by the public to identify such cosmetic; or an appropriate illustration or vignette representing the intended cosmetic use, as required by 21 CFR 701.11(b).

2. Your Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products are misbranded within the meaning of section 4 of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. 1454(c)(3)(B)] as the label does not include a statement of the ingredients as required by 21 CFR 701.3(a). Further, we note that your products are not consistently manufactured with the same ingredients and vary depending on what is available in the neighborhood flora.

3. Your Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products are misbranded within the meaning of section 602(b) of the Act [21 U.S.C. §362(b)] as the label does not include:

a. A statement of the place of business for the manufacturer, as required by 21 CFR 701.12. The business address must include the street address, name of the city, state, and the zip code. The street address may be omitted if the firm is listed in a current city or telephone directory.

b. A net quantity of contents statement, as required by 21 CFR 701.13.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your establishment or 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 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 these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Please note that additional information on the manufacture and labeling of cosmetic products can be found on FDA's website at https://www.fda.gov/cosmetics. For FDA’s guidelines on manufacturing cosmetic products, please see FDA’s Draft Guidance for Industry, Cosmetic Good Manufacturing Practices at https://www.fda.gov/media/86366/download. You are encouraged to review your cosmetic manufacturing process and labeling to ensure compliance with all applicable cosmetic laws and regulations.

Within fifteen 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 fifteen 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 Kimberly A. Dutzek, Compliance Officer, Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217 or via email orahafeast5firmresponses@fda.hhs.gov Any questions you may have regarding this process should be directed to Mrs. Dutzek at (615) 366-7808.

Sincerely,
/S/

Kimberly L. McMillan
Acting Director, Division V
Office of Human and Animal Foods Operations-East

 
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