Notice2023-13329
Vitagene, Inc.; Analysis of Proposed Consent Order To Aid Public Comment
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 23, 2023
Issuing agencies
Federal Trade Commission
Abstract
The consent agreement in this matter settles alleged violations of Federal law prohibiting unfair or deceptive acts or practices. The attached Analysis of Proposed Consent Order to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order--embodied in the consent agreement--that would settle these allegations.
Full Text
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<title>Federal Register, Volume 88 Issue 120 (Friday, June 23, 2023)</title>
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[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41104-41107]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13329]
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FEDERAL TRADE COMMISSION
[File No. 192 3170]
Vitagene, Inc.; Analysis of Proposed Consent Order To Aid Public
Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement; request for comment.
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SUMMARY: The consent agreement in this matter settles alleged
violations of Federal law prohibiting unfair or deceptive acts or
practices. The attached Analysis of Proposed Consent Order to Aid
Public Comment describes both the allegations in the complaint and the
terms of the consent order--embodied in the consent agreement--that
would settle these allegations.
DATES: Comments must be received on or before July 24, 2023.
ADDRESSES: Interested parties may file comments online or on paper by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Please write ``Vitagene, Inc.;
File No. 192 3170'' on your comment and file your comment online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> by following the instructions on the web-
based form. If you prefer to file your comment on paper, please mail
your comment to the following address: Federal Trade Commission, Office
of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex V),
Washington, DC 20580.
FOR FURTHER INFORMATION CONTACT: James Trilling (202-326-3497), or
Elisa Jillson (202-326-3001), Attorneys, Division of Privacy and
Identity Protection, Bureau of Consumer Protection, Federal Trade
Commission, 600 Pennsylvania Ave. NW, Washington, DC 20580.
[[Page 41105]]
SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule Sec. 2.34, 16 CFR
2.34, notice is hereby given that the above-captioned consent agreement
containing a consent order to cease and desist, having been filed with
and accepted, subject to final approval, by the Commission, has been
placed on the public record for a period of 30 days. The following
Analysis to Aid Public Comment describes the terms of the consent
agreement and the allegations in the complaint. An electronic copy of
the full text of the consent agreement package can be obtained at
<a href="https://www.ftc.gov/news-events/commission-actions">https://www.ftc.gov/news-events/commission-actions</a>.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before July 24, 2023.
Write ``Vitagene, Inc.; File No. 192 3170'' on your comment. Your
comment--including your name and your state--will be placed on the
public record of this proceeding, including, to the extent practicable,
on the <a href="https://www.regulations.gov">https://www.regulations.gov</a> website.
Because of heightened security screening, postal mail addressed to
the Commission will be subject to delay. We strongly encourage you to
submit your comments online through the <a href="https://www.regulations.gov">https://www.regulations.gov</a>
website. If you prefer to file your comment on paper, write ``Vitagene,
Inc.; File No. 192 3170'' on your comment and on the envelope, and mail
your comment to the following address: Federal Trade Commission, Office
of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex V),
Washington, DC 20580.
Because your comment will be placed on the publicly accessible
website at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, you are solely responsible for
making sure your comment does not include any sensitive or confidential
information. In particular, your comment should not include sensitive
personal information, such as your or anyone else's Social Security
number; date of birth; driver's license number or other state
identification number, or foreign country equivalent; passport number;
financial account number; or credit or debit card number. You are also
solely responsible for making sure your comment does not include
sensitive health information, such as medical records or other
individually identifiable health information. In addition, your comment
should not include any ``trade secret or any commercial or financial
information which . . . is privileged or confidential''--as provided by
section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule Sec.
4.10(a)(2), 16 CFR 4.10(a)(2)--including competitively sensitive
information such as costs, sales statistics, inventories, formulas,
patterns, devices, manufacturing processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule Sec. 4.9(c). In
particular, the written request for confidential treatment that
accompanies the comment must include the factual and legal basis for
the request and must identify the specific portions of the comment to
be withheld from the public record. See FTC Rule Sec. 4.9(c). Your
comment will be kept confidential only if the General Counsel grants
your request in accordance with the law and the public interest. Once
your comment has been posted on the <a href="https://www.regulations.gov">https://www.regulations.gov</a>
website--as legally required by FTC Rule Sec. 4.9(b)--we cannot redact
or remove your comment from that website, unless you submit a
confidentiality request that meets the requirements for such treatment
under FTC Rule Sec. 4.9(c), and the General Counsel grants that
request.
Visit the FTC website at <a href="http://www.ftc.gov">http://www.ftc.gov</a> to read this document
and the news release describing the proposed settlement. The FTC Act
and other laws the Commission administers permit the collection of
public comments to consider and use in this proceeding, as appropriate.
The Commission will consider all timely and responsive public comments
it receives on or before July 24, 2023. For information on the
Commission's privacy policy, including routine uses permitted by the
Privacy Act, see <a href="https://www.ftc.gov/site-information/privacy-policy">https://www.ftc.gov/site-information/privacy-policy</a>.
Analysis of Proposed Consent Order To Aid Public Comment
The Federal Trade Commission (the ``Commission'') has accepted,
subject to final approval, an agreement containing a consent order from
1Health.io Inc. (formerly known as, and doing business as, Vitagene,
Inc.) (``Vitagene''). The proposed consent order (``proposed order'')
has been placed on the public record for 30 days for receipt of
comments from interested persons. Comments received during this period
will become part of the public record. After 30 days, the Commission
again will review the agreement and the comments received, and will
decide whether it should withdraw from the agreement or make final the
agreement's proposed order.
Since 2015, Vitagene has sold ``DNA Health Test Kits'' to
consumers. In each DNA Health Test Kit, Vitagene instructs the consumer
to provide a saliva sample by mail. Vitagene contracts with a testing
lab to analyze the sample and map a portion of the consumer's genetic
code.
Vitagene combines the testing lab's DNA analysis with the
consumer's answers to an online ``health questionnaire'' that probes
the individual's health history, lifestyle, and family health history.
Using this information, Vitagene generates reports about the consumer's
health and wellness (``Health Reports'') and ancestry. Vitagene also
sells to the consumer Health Reports that it creates by using the
consumer's answers to an online ``lifestyle questionnaire'' and raw DNA
data that the consumer sends to Vitagene after the consumer has
obtained DNA tests from certain companies other than Vitagene. The
retail cost for a package that includes a Health Report has ranged from
$29 to $259, with higher-priced packages including add-ons such as
subscriptions to personalized vitamin packs and nutritional coaching.
The Health Reports that Vitagene creates contain numerous facts
about the consumer's genetics and health. For example, one type of
Health Report first lists the consumer's name, date of birth, and
referring doctor or dietician, and then identifies salient genotype
data, pertinent questionnaire answers, and, based on the genotype data
and questionnaire answers, the level of risk for having or developing
certain health conditions, such as high LDL cholesterol, high
triglycerides, obesity, or blood clots.
As part of its information technology infrastructure, Vitagene
stores consumers' health and genetic information in the Amazon Web
Services (``AWS'') Simple Storage Service (the ``Amazon S3 Datastore'')
in virtual containers, called ``buckets.'' The files Vitagene has
stored in Amazon S3 Datastore buckets include, among other things,
consumers' Health Reports; genotype data called single-nucleotide
polymorphisms (``SNPs''), which are the most common type of genetic
variation among people; and other raw genotype data.
The proposed complaint alleges that, despite the fact that Vitagene
has stored consumers' sensitive personal information in the Amazon S3
Datastore, Vitagene did not uniformly apply basic safeguards to the
data in each of its Amazon S3 Datastore buckets. In particular, the
proposed complaint alleges that, in or about 2016,
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Vitagene created a publicly accessible bucket in which the company
stored Health Reports for at least 2,383 consumers and a publicly
accessible bucket in which it stored raw genetic data (sometimes
accompanied by first name) for at least 227 consumers. The proposed
complaint alleges that Vitagene's failure to use access controls to
restrict access to this sensitive data, encrypt it, log or monitor
access to it, or inventory it, to help ensure ongoing security resulted
in Vitagene publicly exposing the data until July 2019. According to
the proposed complaint, between July 2017 and June 2019, Vitagene
received at least three warnings that it was storing consumers'
unencrypted health, genetic, and other personal information in publicly
accessible buckets.
The proposed complaint alleges Vitagene changed its name from
Vitagene, Inc. to 1Health.io Inc. in October 2020. According to the
proposed complaint, the company published revised privacy policies in
April and December 2020 that apply to all the company's customers,
including those who purchased products and services from the company
solely before April 2020. The proposed complaint alleges that, compared
to Vitagene's previous privacy policy, the company's 2020 privacy
policies significantly expand the types of third parties with whom, and
the purposes for which, the company may share consumers' sensitive
personal information. The company did not provide direct notice to
consumers of the change, but it also did not implement the expanded
sharing.
The proposed five-count complaint alleges that Vitagene violated
section 5(a) of the FTC Act by misrepresenting the company's data
security and privacy practices, and by unfairly making material
retroactive changes to the company's policies regarding third-party
sharing of sensitive personal information.
Proposed complaint Count I alleges Vitagene deceived consumers by
misrepresenting that it exceeded industry-standard security practices.
On a web page that Vitagene devoted to describing its privacy
practices, Vitagene claimed that ``[w]e use the latest technology and
exceed industry-standard security practices to protect your privacy.''
The proposed complaint alleges that Vitagene's public exposure of
consumers' Health Reports, raw genetic data, and other personal
information in AWS S3 buckets until July 2019 contradicted this claim.
Proposed complaint Count II alleges Vitagene deceptively claimed on
multiple web pages that it stored consumers' DNA results without name
or any other common identifying information. The proposed complaint
alleges that this claim was deceptive because Vitagene stored
consumers' DNA results with their names and other common identifying
information.
Proposed complaint Count III alleges Vitagene deceptively claimed
that it would remove all of a consumer's information if the consumer
requested deletion of his or her data. Vitagene made this claim on a
web page that Vitagene devoted to describing its privacy practices. The
proposed complaint alleges that the claim was deceptive because, from
approximately 2016 through July 1, 2019, Vitagene's lack of a data
inventory made it impossible for the company to search comprehensively
in response to consumers' requests for Vitagene to delete their data.
Proposed complaint Count IV alleges Vitagene deceived consumers by
claiming on multiple web pages that it destroys consumers' physical DNA
saliva samples shortly after analysis of them. The proposed complaint
alleges that this claim was deceptive because, beginning in
approximately December 2016, Vitagene did not have a contract provision
with its genotyping laboratory partner requiring such destruction.
Proposed complaint Count V alleges it was unfair for Vitagene to
post on its websites in April and December 2020 revised privacy
policies that describe materially expanded practices for the company's
sharing of consumers' sensitive health and genetic information with
third parties--including the information of consumers who purchased
products and services from Vitagene solely before April 2020--without
taking any additional steps to notify consumers or obtain consumers'
consent.
The proposed order contains provisions to address Vitagene's
conduct and prevent it from engaging in the same or similar acts or
practices in the future. Part I of the proposed order prohibits
Vitagene from misrepresenting (1) the extent to which it meets or
exceeds industry-standard security or privacy practices, (2) the extent
to which it stores any Health Information (as defined in the order)
with any other element of Personal Information (as also defined in the
order), (3) the extent to which, or the purposes for which, it
collects, uses, discloses, maintains, deletes, or destroys a consumer's
(i) physical DNA sample or (ii) Personal Information upon request, (4)
it is a member of, adheres to, complies with, is certified by, or
otherwise participates in, any privacy or security program sponsored by
a government entity or third party, (5) the extent to which it
otherwise protects the privacy, security, availability,
confidentiality, or integrity of Personal Information, or (6) it has
received approval or authorization for its claims, products, or
services from any government agency.
Part II prohibits Vitagene from disclosing Health Information to
any Third Party (as defined in the order) unless the company obtains
the Affirmative Express Consent (as also defined in the order) of the
individual who is identifiable by the Health Information. Part III
requires Vitagene to instruct any laboratory that collected physical
DNA samples pursuant to a contract with Vitagene to destroy any such
sample that the laboratory retained for more than 180 days after
Vitagene accepted the results of the analysis of the sample.
Part IV requires Vitagene to establish, implement, and maintain a
comprehensive information security program that protects the security,
confidentiality, and integrity of Personal Information. Part V requires
Vitagene to obtain initial and biennial data security assessments from
a third-party assessor for twenty years. Part VI requires Vitagene to
disclose all material facts to the assessor and prohibits Vitagene from
misrepresenting any fact material to the assessments required by Part
V.
Part VII requires Vitagene to submit to the Commission an annual
certification that Vitagene has implemented the requirements of the
Order and is not aware of any material noncompliance that has not been
corrected or disclosed to the Commission. Part VIII requires Vitagene
to submit a report to the Commission if it discovers any Covered
Incident (as defined in the order).
Part IX requires Vitagene to pay $75,000 in monetary relief. Part X
provides that the Commission may use Vitagene's monetary relief payment
to provide, and pay expenses related to the administration of, consumer
redress. Part XI requires Vitagene to provide the Commission customer
information to enable the Commission to efficiently administer consumer
redress.
Parts XII-XV are reporting and compliance provisions. Part XII
requires Vitagene to acknowledge receipt of the order and distribute it
to persons with responsibilities relating to the subject matter of the
order. Part XIII requires Vitagene to submit an initial compliance
report to the Commission and notify the Commission of changes in
Vitagene's corporate status. Part XIV requires Vitagene to create and
retain certain documents relating to its compliance
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with the order. Part XV requires that Vitagene provide the Commission
additional information or compliance reports, as requested. Part XVI
states that the proposed order will remain in effect for 20 years, with
certain exceptions.
The purpose of this analysis is to aid public comment on the
proposed order. It is not intended to constitute an official
interpretation of the complaint or proposed order, or to modify in any
way the proposed order's terms.
By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2023-13329 Filed 6-22-23; 8:45 am]
BILLING CODE 6750-01-P
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</html>Indexed from Federal Register on June 23, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.