FDA goes after Miami nutrition company

[Guest guest]

Caribe Natural LLC 5/14/12

[Department of Health and Human Services logo]Department of Health and Human

Services

Public Health Service

Food and Drug Administration

Florida District

555 Winderley Place, Suite 200

Maitland, Florida 32751

Telephone:

FAX:

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-33

May 14, 2012

Maida E. Chaveco

Owner

Caribe Natural, LLC

13121 SW 122nd Avenue

Miami, FL 33186-6231

Dear Mrs. Chaveco:

This is to advise you that the U.S. Food and Drug Administration (FDA) inspected

your firm Caribe Natural, LLC from September 6, 2011 to November 23, 2011,

located at 13121 SW 122nd Ave, Miami, Florida.

During the inspection, you informed our investigators that your firm is an

own-label distributor of your GERMA® brand dietary supplements that has entered

into agreements with contract manufacturers to manufacture your dietary

supplement products. The Vice-President of your firm, Mr. Gerardo Barillas,

stated that you purchase a competitor's product and request contract

manufacturers to manufacture the same product so that you can distribute the

product under your own label. Mr. Barillas stated that you use the same list of

ingredients that is printed on the competitor's brand label for the label on

your product. As an own-label distributor that contracts with other

manufacturers to manufacture dietary supplements that your firm releases for

distribution under your firm's name, FDA considers you to be a manufacturer of

such dietary supplements. You have ultimate responsibility for the dietary

supplements that you introduce or deliver for introduction into interstate

commerce.

The inspection revealed serious violations of the Current Good Manufacturing

Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding

Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part

111 (21 CFR Part 111). These violations cause your dietary supplement products

to be adulterated within the meaning of section 402(g)(1) of the Federal Food,

Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that the dietary

supplement products have been prepared, packed, or held under conditions that do

not meet CGMP regulations for dietary supplements.

In addition, after reviewing your products' labels and your website

www.caribenatural.com<http://www.caribenatural.com>, FDA has determined that

your " Colostrum 'A' Plus " and " Urobiol " products are promoted for conditions

that cause the products to be drugs under section 201(g)(1)( of the Act [21

U.S.C. § 321(g)(1)(]. The therapeutic claims on your product labels and

website establish that these products are drugs because they are intended for

use in the cure, mitigation, treatment, or prevention of disease in humans. The

marketing of your products with these claims violates the Act.

You may find the Act and FDA's regulations through links in FDA's home page at

www.fda.gov<file:///C:\Documents%20and%20Settings\helen.sim\Local%20Settings\Tem\

porary%20Internet%20Files\Content.IE5\Documents%20and%20Settings\jxd\Local%20Set\

tings\Temporary%20Internet%20Files\www.fda.gov>.

Dietary Supplement CGMP Violations

1. Your firm failed to make and keep written procedures for the

responsibility of quality control operations, as required by 21 CFR 111.103 and

21 CFR 111.140((1). As an own-label dietary supplement distributor that

contracts with a manufacturer to manufacture a dietary supplement that you

distribute under your own label, you have an obligation to know what and how

manufacturing activities are performed so that your firm can make decisions

related to whether your packaged and labeled dietary supplement products conform

to established specifications and whether to approve and release the products

for distribution [see 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm's

quality control personnel must ensure that your manufacturing, packaging,

labeling, and holding operations ensure the quality of your dietary supplements

and that your dietary supplements are packaged and labeled in accordance with

established specifications, as required by 21 CFR 111.105 and 21 CFR 111.120(.

We have reviewed your response dated December 12, 2011 and determined it to be

inadequate. Your procedures related to quality control did not address important

requirements for quality control operations. Specifically, your procedures did

not address your quality control operations' responsibilities for conducting a

material review and making a disposition decision for returned products, as

required by 21 CFR 111.103 and 21 CFR 111.113(a)(5), or for approving for

release or rejecting any packaged and labeled dietary supplement (including a

repackaged or relabeled dietary supplement) for distribution, as required by 21

CFR 111.127(h).

2. Your firm failed to make and keep written procedures for product

complaints, as required by 21 CFR 111.570((1). Specifically, your firm did not

have written procedures for the handling of product complaints regarding the

dietary supplement products you distribute and for adequately investigating

complaints and documenting the findings of an investigation and follow-up.

We have reviewed your response dated December 12, 2011 and determined it to be

inadequate. Specifically, it appears you have provided a written form for

documenting product complaints and the action taken in response. However, you

have not provided written procedures on how to investigate the complaint and how

quality control personnel will be involved in the review and approval process.

3. Your firm failed to hold components and dietary supplements under

appropriate conditions of temperature, humidity, and light so that the identity,

purity, strength, and composition of the components and dietary supplements are

not affected, as required by 21 CFR 111.455(a), and your firm failed to

establish and follow written procedures for holding and distributing operations,

as required by 21 CFR 111.453. Specifically, you informed our investigators that

you do not measure the temperature or humidity levels in your product storage

warehouse.

We have reviewed your response dated December 12, 2011 and determined it to be

inadequate. While your response provides a form for documenting the person

responsible for temperature and humidity record-keeping, your response did not

establish written procedures for controlling and monitoring the temperature,

humidity, and light of your facility where finished and bulk products are

stored.

4. Your firm failed to make and keep written procedures for returned

dietary supplements, as required by 21 CFR 111.535((1). Specifically, you did

not have written procedures for handling any returned dietary supplements,

including when a returned dietary supplement may be salvaged in accordance with

21 CFR 111.520, or when a returned dietary supplement must be destroyed or

otherwise suitably disposed of in accordance with 21 CFR 111.515.

We have reviewed your response dated December 12, 2011 and determined it to be

inadequate. Your response indicates that you will discard damaged and/or expired

products. However, your procedures failed to include procedures for identifying

and quarantining returned dietary supplements until quality control personnel

conduct a material review and make a disposition decision, as required by 21 CFR

111.510. Your written procedures also did not include procedures for when a

returned dietary supplement may be salvaged in accordance with 21 CFR 111.520.

In addition, as required by 21 CFR 111.503 and 21 CFR 111.535(, you failed to

establish written procedures for making and keeping the following records: any

material review and disposition decision on a returned dietary supplement; the

results of any testing or examination conducted to determine compliance with

product specifications established under 21 CFR 111.70(e); documentation of the

reevaluation by quality control personnel of any dietary supplement that is

reprocessed; and the determination by quality control personnel of whether the

reprocessed dietary supplement meets product specifications established in

accordance with 21 CFR 111.70(e).

5. Your firm did not establish written procedures for holding and

distributing operations, as required by 21 CFR 111.453. Specifically, you

indicated to our investigator that you receive bulk dietary supplement product

from your contract manufacturer, but you have no written procedures for holding

and distributing operations.

We have reviewed your response dated December 12, 2011 and determined it to be

inadequate. Your " Warehouse Product Receiver Guidelines " state that " [t]he goods

must be reviewed and checked properly before being placed on the shelves. "

However, your procedures did not address holding dietary supplements under

conditions that do not lead to the mix-up, contamination, or deterioration of

dietary supplements, as required by 21 CFR 455©.

Further, our review of the inspectional evidence, including the information you

provided to our investigators, revealed the following violations:

6. Your firm failed to establish a specification for any point, step, or

stage in the manufacturing process where control is necessary to ensure the

quality of the dietary supplement and that the dietary supplement is packaged

and labeled as specified in the master manufacturing record, as required by 21

CFR 111.70(a).

7. Your firm failed to establish specifications for each component that you

use in the manufacture of your dietary supplement products, as required by 21

CFR 111.70(.

8. Your firm failed to prepare and follow a written master manufacturing

record for each unique formulation of dietary supplement that you manufacture,

and for each batch size, to ensure uniformity in the finished batch from batch

to batch, as required by 21 CFR 111.205(a).

Unapproved New Drugs

Examples of some of the therapeutic claims observed on your product labels and

website include:

COLOSTRUM " A " PLUS DIETARY SUPPLEMENT- 500 mg (120 CAPS)

· " Helps to combat Virus and Bacteria "

· " IgG mother's immune factor neutralizes and destroys poison toxins and

invading pathogens "

UROBIOL With Nirurin

· " [D]isperses calcification. Breaks kidney gallstones. "

Because your " Colostrum 'A' Plus " and " Urobiol " products are not generally

recognized as safe and effective for the above referenced uses, they are " new

drugs " as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under

section 505(a) of the Act [21 U.S.C. § 355(a)], new drugs may not be legally

marketed in the U.S. without prior approval from FDA. FDA approves new drugs on

the basis of scientific data submitted by a drug sponsor to demonstrate that the

drug is safe and effective.

Further, because your " Colostrum 'A' Plus " and " Urobiol " products are offered

for conditions that are not amenable to self-diagnosis and treatment by

individuals who are not medical practitioners, adequate directions for use

cannot be written so that a layperson can use these drugs safely for their

intended purposes. Thus, your products are also misbranded under section

502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that their labeling fails to

bear adequate directions for their intended uses. The introduction of a

misbranded drug into interstate commerce is a violation of section 301(a) of the

Act [21 U.S.C. § 331(a)].

Misbranded Dietary Supplements

Your GERMA 9 Syrups, Vigaril Natural Stimulant, and Germa Colostrum " A " Plus

Dietary Supplement products are misbranded within the meaning of section

403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the labels failed to

comply with 21 CFR 101.36 as follows:

· Under 21 CFR 101.36©(1), dietary ingredients contained in the

proprietary blend that are listed under paragraph ((2) of this section must be

declared in accordance with paragraph ((2) of this section. Specifically, your

Vigaril Natural Dietary Supplement and Germa 9 Syrup products list Zinc

Gluconate, Niacinamide, and Vitamin C, respectively, which are dietary

ingredients under paragraph ((2). However, they are not declared in the

proprietary blend in accordance with 21 CFR 101.36©(1) because the dietary

ingredients which have a Reference Daily Intake (RDI) or a Daily Reference Value

(DRV) as established in 21 CFR 101.9© are not listed separately from the other

dietary ingredients in your proprietary blend which do not have an RDI or DRV

established. In addition, dietary ingredients in the Germa 7 and 9 Syrup

products must be indented under the " Proprietary Herbal Blend, as required by 21

CFR 101.36©(2).

· Under 21 CFR 101.36((2) and (3), the names of dietary ingredients

that have daily values must be listed in a specified order and in a column

display and dietary ingredient that do not have daily values must be listed in a

column or linear display. Specifically, your Germa Colostrum " A " Plus Dietary

Supplement product does not lists the individual dietary ingredients that you

described as " vitamins " and " minerals " in the nutrition information as dietary

ingredients that have an RDI or DRV established, as required by 21 CFR

101.36((2).

· Under 21 CFR 101.36((2)(iii), the percent of the daily value must be

declared for all dietary ingredients for which FDA has established daily values.

Specifically, your Germa Malt Extract with Vitamins Reinforced by B-12 dietary

supplement does not list the daily values for the dietary ingredients in your

product.

Your Vigaril Natural Stimulant dietary supplement product is misbranded within

the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it

purports to contain ginseng, but the purported ginseng ingredient is not from a

plant classified with the genus Panax. Section 403(u) of the Act, added by the

Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that

the term " ginseng " may only be considered to be a common or usual name (or part

thereof) for any herb or herbal ingredient derived from a plant classified

within the genus Panax. Your product contains an ingredient identified as

Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be

declared under a name that includes the term " ginseng " because it is not from

the genus Panax.

Your Vigaril Natural Stimulant, Germa 9 Syrup, Germa 7 Syrups, Germa Colostrum

" A " Plus, Germa Malt Extract with Vitamins Reinforced by B-12 and Germa Urobiol

with Nirurin dietary supplement products are misbranded within the meaning of

section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a

domestic address or domestic phone number through which the responsible person

may receive a report of a serious adverse event associated with such dietary

supplement.

Your Vigaril Natural Stimulant and Germa Urobiol with Nirurin dietary supplement

products are misbranded within the meaning of section 403(s)(2)© of the Act

[21 U.S.C. § 343(s)(2)©], in that the labels fail to 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).

Your Vigaril Natural Stimulant, Germa Malt Extract with Vitamins Reinforced by

B-12 and Germa Urobiol with Nirurin dietary supplement products are misbranded

within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the

product labels contain information in two languages but do not repeat all the

required information in both languages. As required by 21 CFR 101.15©, if a

product label contains any representation in a foreign language or foreign

characters, all words, statements, and other information required by or under

authority of the Act to appear on the label must appear in the foreign language.

For example, you do not repeat the nutrition labeling information ( " Supplement

Facts panel) information in Spanish.

Your Germa Colostrum " A " Plus Dietary Supplement is misbranded within the

meaning of section 403(i)(2) in that it is fabricated from two or more

ingredients, but the label fails to list the individual excipients as required

by 21 CFR 101.4(g). Your label lists " excipients, " but fails to list the names

of the individual excipients.

The violations mentioned above are not intended to be an all-inclusive list of

violations that exist in connection with your products and their labeling. It is

your responsibility to ensure that all products marketed by your firm comply

with the Act and its implementing regulations.

You should take prompt action to correct the violations described above and

prevent their further recurrence. Failure to do so may result in enforcement

action without further notice. The Act authorizes the seizure of illegal

products and injunctions against manufacturers and distributors of those

products [21 U.S.C. §§ 332 and 334].

You should respond in writing within fifteen (15) working days from your receipt

of this letter. Your response should outline the specific things you are doing

to correct the violations noted above. You should include in your response,

documentation and any other useful information that would assist us in

evaluating your corrections. If you cannot complete all corrections before you

respond, you should explain the reason for your delay and state when you will

correct any remaining violations.

Please send your reply to the Food and Drug Administration, Attention: Winston

R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida

32751. If you have questions regarding any issues in this letter, please contact

Mr. Alejo at .

Sincerely,

/S/

Emma R. Singleton

Director, Florida District

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive - Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com<www.mraclinicalresearch.com/>

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