WARNING LETTER
Dr. Berne’s Whole Health Products
MARCS-CMS 665456 —
November 22, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Dr. Berne’s Whole Health Products
174 Tesuque Village Rd, Unit 458
Tesuque
,
NM
87574
United States
hello@drsamberne.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
November 22, 2023
RE: 665456
Dear Samuel Berne:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://shop.drsamberne.com/ in August 2023. The FDA has observed that your website offers the products “Dr. Berne’s MSM Eye Drops 5%,” “Dr. Berne’s MSM Eye Drops 15%,” and “Dr. Berne’s MSM Eye Mist 15%” for sale in the United States. Based on our review, these products 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 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).
Your “Dr. Berne’s MSM Eye Drops 5%,” “Dr. Berne’s MSM Eye Drops 15%,” and “Dr. Berne’s MSM Eye Mist 15%” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.
In addition, the results of the FDA laboratory testing of a batch of Dr. Berne's MSM Eye Drops 5% demonstrate that this drug product is adulterated within the meaning of section 501(a)(1) of the FD&C Act, 21 U.S.C. 351(a)(1), in that it consists in whole or in part of any filthy, putrid, or decomposed substance. Introducing or delivering this product for introduction into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Drugs
Based on a review of your website, your “Dr. Berne’s MSM Eye Drops 5%,” “Dr. Berne’s MSM Eye Drops 15%,” and “Dr. Berne’s MSM Eye Mist 15%” products 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 from your website https://shop.drsamberne.com/ that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
From the Customer Sheet section on the product pages for “Dr. Berne’s MSM Eye Drops 5%” https://shop.drsamberne.com/collections/msm-drops/products/msm-drops, “Dr. Berne’s MSM Eye Drops 15%” https://shop.drsamberne.com/collections/msm-drops/products/15-msm, and “Dr. Berne’s MSM Eye Mist 15%” https://shop.drsamberne.com/collections/msm-drops/products/msm-eye-mist:
“
Allergies
[,] MSM has strong anti-inflammatory activity in the body, which can greatly assist in reducing inflammation that is common with allergic reactions. Both environmental and food allergies can be reduced with MSM. Asthma and hay fever sufferers also have reported significant relief with MSM.”
From your March 16, 2018, YouTube video titled, “MSM Eye Massage (Eye Exercise)” on your webpage https://www.drsamberne.com/msm-eye-massage/ where you demonstrate an eye massage with one of your MSM eye drop products:
“This MSM eye massage is great for inflammatory eye conditions, blepharitis, dry-eye, improving the lymph system, and stimulation of tears.”
From your July 6, 2022, YouTube video titled, “Diagnosing Macular Degeneration” on your webpage https://www.drsamberne.com/diagnosing-macular-degeneration/:
“. . . I’d start using my natural eyedrops called MSM drops, and I would get the 5%, MSM and the 5% MSM. MSM is a sulfur molecule is the third leading trace mineral found in the body. And it supports collagen in the eye. It’s an anti inflammatory agent. And it will lubricate and moisturize your eyes, which neutralizes drusen production because drusen likes to grow in a dry environment. And the other thing it will do is it will lubricate your macula. So when you’ve got dry macular degeneration, the macula is basically drying out. And that’s where you start getting these distortions.”
From your October 12, 2022, YouTube video titled, “I’m Answering Your Questions! Sulfa vs. Sulfur” on your webpage https://www.drsamberne.com/im-answering-your-questions-sulfa-vs-sulfur/:
“[T]he difference between those two pharmaceuticals and MSM eyedrops, so MSM definitely is an anti inflammatory agent. It’s a natural sulfur product that is found in your body.”
From your October 31, 2022, YouTube video titled, “I’m Answering Your Questions” on your webpage https://www.drsamberne.com/im-answering-your-questions-12/:
“My MSM eyedrops are really great for corneal dystrophies, like fuks, and it’s really about hydrating, protecting your eyes from too much sunlight, and also blue light . . .”
Your “Dr. Berne’s MSM Eye Drops 5%,” “Dr. Berne’s MSM Eye Drops 15%,” and “Dr. Berne’s MSM Eye Mist 15%” products are not generally recognized as safe and effective (GRASE) for their above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Adulteration Violations
FDA laboratory testing of a batch of Dr. Berne's MSM DROPS 5% Solution drug product (lot 6786, “Best By 032025”) found that it contained microbial contamination. The sample results failed to meet USP <71>, sterility tests. Therefore, this drug product is adulterated under section 501(a)(1) of the FD&C Act, in that it consists in whole or in part of any filthy, putrid, or decomposed substances.
Fungal and bacterial microorganisms were identified from drug product samples analyzed for sterility, which included, but were not limited to Exophiala sp. and Bacillus spp. The presence of microorganisms in conjunction with the route of administration poses a high risk to patients. Using contaminated eye drops could result in a range of ocular infections, from minor to serious vision-threatening infections, which could progress in some cases to a life-threatening infection.
During the FDA teleconference on August 21, 2023, you stated that your drug products are manufactured by a contract manufacturer, and you agreed to conduct a voluntary recall of the lot currently in U.S. distribution.
On August 26, 2023, you voluntarily recalled lot 6786 of Dr. Berne’s MSM DROPS 5% Solution to the consumer level due to microbial contamination. In addition, you are voluntarily recalling all lots of Dr. Berne’s MSM DROPS 5% Solution, Dr. Berne’s MSM DROPS 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution to the consumer level due to potential microbial contamination, as noted on the following FDA website:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-bernes-whole-health-products-issues-voluntary-nationwide-recall-dr-bernes-msm-drops-5-and-15
On August 22, 2023, FDA issued the following drug alert warning to consumers not to purchase and to immediately stop using Dr. Berne’s MSM Drops 5% Solution due to bacterial contamination, fungal contamination, or both:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops-due
Use of Contract Manufacturers
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act. For additional information regarding contract manufacturing, please refer to FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
Conclusion
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 any violations may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, 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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
11/28/2023
Regulated Product(s)
Drugs