Is my product a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated?

Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.

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Legal action pushes FDA on its response to qualified health claims

A federal judge recently held that the disclaimer required by the FDA for a qualified health claim about green tea and the risk of cancer is so strongly worded that it “effectively negates” the manufacturer’s claim.

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FDA warns consumers about grapefruit juice

Grapefruit juice and fresh grapefruit can interfere with the action of some prescription drugs, FDA warns consumers.

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Dietary supplements regulations make IRS rules read like Hemingway

Dietary supplement regulation requires companies to seek careful legal guidance before bringing products to market.

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Weight loss products raise legal issues

As with HCG and other weight loss products in the U.S., weight loss products become the focus of regulation in the Gulf region.

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R U Making Unauthorized Disease Claims with Your Dietary Supplements

Does your dietary supplement make illegal disease claims or authorized structure/function claims? How do you know?

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Legal Advice For New Dietary Supplement, Nutritional Product or Cosmetic

Manufacturers of new dietary supplements, cosmetics, and nutraceuticals can find legal advice about labeling and FDA-compliant claims by following these guidelines.

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Physician use of bioidential hormones raises legal concerns

Medical use of bioidentical hormones raises legal concerns that can be addressed by solid attorney advice and a carefully crafted informed consent.

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Is it legal for an integrative care center, medical spa, or clinical practitioner to make a profit by selling dietary supplements?

The question of selling dietary supplements in the clinical care setting arises with many clients in the holistic health care field who care about legal and regulatory issues.

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When Integrative Medicine Physicians Sell Dietary Supplements: Legal Issues

Serious legal issues can arise when physicians and CAM practitioners sell dietary supplements.

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FTC Cracks Down on Weight Loss Products

Dietary supplement labeling issues come to the fore again, which is why manufacturers and distributors of dietary supplements and cosmetics need good legal advice on their labeling.

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FDA Substantiation of Dietary Supplement Claims

Dietary supplement claims must be substantiated by scientific evidence, the FDA has guidance for industry about this.

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Green MSM FDA Warning Letter

Search the FDA warning letters if you want to start researching whether a given dietary supplement claim or label is acceptable or potentially illegal.

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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements

The FDA regulation regarding structure-function claims is a good place to start for evaluating whether these claims are permissible or violate the federal Food, Drug & Cosmetic Act.

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Drugs Dietary Supplements and Structure-Function Claims

When does a dietary supplement become a drug?

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Guidance for Dietary Supplement Industry from the FDA

The FDA also has issued guidance summarizing the 136 page regulation on structure-function claims.

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Claims that can be made for conventional foods and dietary supplements

What's the difference between health claims, nutrient content claims, and structure/function claims?

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Herbs for calm and restful sleep

A dietary supplement company announced release of a product to help "calm the mind and maintain restful sleep."

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Anti-kickback laws concern integrative medicine doctors

Our law practice has recently represented physicians and alternative care practitioners on anti-kickback issues.

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FDA steps up enforcement actions against dietary supplement manufacturers

The FDA is stepping up enforcement actions against dietary supplement manufacturers, sometimes bypassing warning letters.

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Dietary Supplements: structure-function and implied disease claims

Dietary supplements that make claims to "treat disease" suddenly become classified as drugs.

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Physicians, Dietary Supplement Sales, and Kickbacks 2

States have different laws governing physician sales of dietary supplements and other health care products.

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Physician Sales of Dietary Supplements - Referrals, Conflicts of Interest

Many physicians are calling our law office asking about generating passive income through referrals to dietary supplement manufacturers.

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In-office physician sale of dietary supplements: conflict of interest

Can MDs or DOs sell patients dietary supplements from the office?

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Do Canadian pharmacy students know about herbal medicine

Knowledge of herbal medicine is not a yes-no question.

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Most commonly used herbs, acupuncture benefits, faith heals

Herbal medicine, acupuncture, and faith are all in the news.

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California law for non-licensed practitioners and nutritional advice

California law dealing with unlicensed health care providers also addresses a topic often neglected: advice involving nutrition.

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Complementary and alternative medicine doctor urges restraint on energy drinks

Energy drinks can cause a host of health problems, warns one CAM physician.

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Labeling dietary supplements - FDA industry regulation

For those seeking basic FDA regulatory guidance on dietary supplement labeling, there is a handy summary of regulation avaiable to industry.

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Market America, Inc. designing vitamins to help with autism

Market America, Inc. (what a great name) is focusing on nutritional supplementation designed for children.

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Vitamin C can impede tumor growth

Researchers report that Vitamin C can impede tumor growth, just as Linus Pauling had claimed. Continue Reading...

World Health Organization Reports On Liver Damage Associated With Kava

The World Health Organization reports On liver damage Associated With Kava. Continue Reading...

Vitamin D therapy discussed in detail

Vitamin D therapy has a pathway pattern that is species-specific, scientists have found. Continue Reading...

adverse effects of using prescription drugs with natural health products underreported

The adverse effects of using prescription drugs side by side with natural health products (NHP) are being under-reported in Canada. Continue Reading...

Selenium supplements might increase risk of diabetes

Researchers warn that selenium supplements could increase risk of diabetes. Continue Reading...

Study cautions use of herbal remedies for depression and anxiety

A UK study cautions those using herbal remedies for depression and anxiety.

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NNFA Japan Urges Japan To Take "Strategic Approach" In Regulating Names Of Foods And Dietary Supplements

The Natural Nutritional Foods Association is working for better dietary supplement labeling in Japan.

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Singapore finds adulterated herbal medicine

The Singapore Health Sciences Authority is warning consumers about an herbal medicine product being adulterated and having serious adverse effects.

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Green tea may help treat bladder disease

Green tea makes the news again with a study of its effect on inflammatory bladder disease.

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Center to study Echinacea and St. John's wort receives funding renewal

A five-year-old research center dedicated to understanding and improving Echinacea and Hypericum perforatum (St. John's wort) has received $4.4 million in continuation funding from the National Institutes of Health.

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Ginseng or ginkgo biloba supplements unlikely to alter drug pharmacokinetics

A study has found it unlikely that supplements such as gingko or ginseng alter drug pharmacokinetics.

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FDA Guidance on Complementary and Alternative Medicine

The FDA draft publication entitled "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" has generated outcry and commentary.

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Dietary supplement recommendation as unlawful practice of medicine

Recommending dietary supplements to a patient can, in some states, cross the line into unlawful practice of medicine.

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American Herbal Products Association urges medical disclosure of dietary supplement use

The American Herbal Products Association (AHPA) has urged doctors and healthcare practitioners to ask patients about their use of herbs in an effort to foster communication on the issue.

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Vitamin D for Cancer Prevention

Two new vitamin D studies using a sophisticated form of analysis called meta-analysis, have revealed new prescriptions for possibly preventing up to half of the cases of breast cancer and two-thirds of the cases of colorectal cancer in the United States.

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Nutritional value of many (most?) foods low

The nutritional value of most foods in one chain of grocery stores was ranked and most scored almost zero.

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Health Canada warns against four supplements promoted to treat disease

Health Canada is advising consumers not to use four unauthorized natural health products that are promoted to treat serious health conditions.

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Complementary and Alternative Medicine Law and Regulation Criticized

Complementary and alternative medicine law and regulation, particularly with respect to dietary supplements, has been labeled a "futile effort costing taxpayers tens of millions of dollars a year."

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DHEA Not Impressing

The dietary supplement DHEA, touted as a "fountain of youth," lacks the benefits claimed, according to Reuters, reporting on a study in The New England Journal of Medicine.

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Dietary Supplements Legislation in India

Dietary supplements are now explicitly regulated in DSHEA-like fashion in India.

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Dietary Supplements Pose Dangers, Health Canada Warns

Dietary supplements and benefits associated with alternative medicine approaches (including nutrition) must be balanced against the potential dangers.

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Healthy Olive Oil Edges Out Vegetable Fats

When it comes to heart health, virgin olive oil may have an edge over other vegetable fats, new research suggests.

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FDA Advisory Panels Biased Toward Drug Approvals

The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer group's analysis released yesterday.

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In Obesity, Portions Count, New Analysis Reveals

Although opinions about nutrition and the real cause of the obesity epidemic abound, a health authority now gives the real scoop: portion size is responsible.

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Omega-3 Has Real Scientific Backing, Researchers Conclude

A high dose of Omega-3 fatty acids apparently helped rescued miner McCloy recover.

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Ayurvedic Herbal Medicines Criticized

An article in Frontline, India's national magazine, argues that the efficacy and safety of Ayurvedic drugs, and especially those claiming to provide miraculous cures, need to be subjected to scientific scrutiny.

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Traditional (Herbal) Medicine Guidelines Proposed

The American Herbal Products Association, in conjunction with about a dozen other CAM organiations in a "Traditional Medicines Congress,"
is proposing new herbal and dietary supplement regulation.

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Oreos and You

The Chicago Tribune reported on the addictive effects of snacks as part of a series on current causes of obesity.

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CODEX Update

The Natural Solutions Foundation has been invited to appear before a Codex Office Public Hearing on CODEX ALIMENTARIUS set for June 9, 2005 at the USDA in Washington.

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FDA Warns Manufacter of Drugs Claims in Herbal Formula

The FDA has sent a warning letter to Two Feathers, a nutraceutical company that produces Two Feathers Healing Formula, also known as Compound X.

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American Association of Oriental Medicine (AAOM) suggests FDA is Interfering Unlawfully with the Practice of Chinese Herbal Medicine

The AAOM recently released a statement criticizing FDA regulation of herbs.

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Cancer patients in Europe use complementary and alternative medicine (CAM)

More than a third of cancer patients in Europe use complementary and alternative medicine (CAM), most often to increase their body's ability to fight the disease, according to the first study of alternative medicine across Europe.

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Herbal Supplements Don't Mix with Surgery

Many Americans take herbal supplements to boost their health, but they may not realize that continuing to do so prior to surgery could have life-threatening results.

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Food is Medicine, U.S. HHS Secretary Says in Dietary Guidelines for Americans 2005

"Our medicines are no farther away than the shelves of the grocery and the sidewalks so that we can use for a brisk walk," said U.S. Secretary of Health and Human Services Tommy Thompson, in a press release announcing the Dietary Guidelines for Americans 2005

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School Vending Machines Getting Color-coded for Safety

"Vending machines are getting their own color-coded safety guide as part of a campaign started ... by the vending industry to fight childhood obesity," reported the Washington Times.

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Nutritional Genomics Promises to Unravel Links Between Nutrition and Genetics

Newsweek reported that the new model for "nutritional genomics" suggests that just as drug effectiveness varies by individual and interacts with genes, so too do the effectiveness of nutritional strategies.

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National Conference to Examine Effects of Dietary Supplements in Patients Taking Blood Thinning Medications

The National Heart, Lung, and Blood Institute will convene a conference this week to evaluate the risks of interactions between dietary supplements and prescription blood-thinning medications which are used by four million Americans to ward off heart attack or stroke.

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Are Drugs More Dangerous than Supplements?

Ask parents of those teenagers who committed suicide while taking antidepressants, and the parents might respond, "yes, drugs are more dangerous than dietary supplements."

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FDA Announces Major Initiatives for Dietary Supplements

The Food and Drug Administration (FDA) announced three major regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA): a regulatory strategy, an open public meeting, and a draft guidance document for industry.

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Advising Patients Regarding Dietary Supplements

Clinicians often ask: "How do I advise patients when evidence concerning dietary supplements is non-existent or conflicting?" And: "Does selling supplements in my office create an ethical conflict?" Here's an approach to tackling these questions.

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Are Dietary Supplements Unregulated?

Aren't dietary supplements unregulated? How does that affect the institution's ability to handle their use?

The regulatory category of "dietary supplements" causes institutions (and clinicians) considerable confusion, both clinically and legally. A key to clarifying the legal issues is understanding the Dietary Supplements Health Education Act of 1994, or DSHEA.

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Selling Dietary Supplements On-Line

Selling dietary supplements on-line raises a host of legal issues, including rules relating to licensure and scope of practice; malpractice laws; legal rules and regulations by professional boards and organizations regarding conflict-of-interest (in medicine as in other health professions); rules about fraud; and rules governing Internet advertising and promotion.

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